EXERCISE SAFETY ROLE OF FITBITS AMONG WOMEN WITH … · The third component of this PhD research...

EXERCISE SAFETY, FEASIBILITY AND THE

ROLE OF FITBITS AMONG WOMEN WITH

STAGE II+ BREAST CANCER

Benjamin Singh

Bachelor of Clinical Exercise Physiology

Masters by Research

Thesis by monograph

Submitted in fulfilment of the requirements for the degree of

Doctor of Philosophy

School of Public Health and Social Work

Faculty of Health

Queensland University of Technology

2019

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer i

Keywords

Breast cancer; breast neoplasm; exercise; physical activity; wearable technology;

physical activity monitor.

ii Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer iii

Abstract

Breast cancer is the most common cancer among women in Australia [1]. While

stage at diagnosis is not routinely reported at the national level, Queensland data

indicates that 47% of women are diagnosed with stage I disease and 45% are diagnosed

with stage II to IV (8% were unknown) [2]. Women with stages II to IV disease have

a lower, five-year relative survival compared with women with stage I disease (83%

versus 98%, respectively) [1, 2]). Further, breast cancer and its treatment are associated

with significant physical and psychosocial side effects, with higher stages of breast

cancer being associated with more extensive treatment, more severe and frequent

treatment-related side effects, and lower quality of life.

Exercise is considered safe and feasible during and following breast cancer

treatment and is recommended to reduce treatment-related side effects, improve

fitness, function and quality of life [3-6], and potentially improve survival [7]. A

consistent and growing evidence base has led to physical activity recommendations by

international cancer [8] and exercise organisations [5, 9, 10] which are promoted to all

women with breast cancer. Specifically, those diagnosed with breast cancer are

recommended to perform at least 150 minutes of moderate intensity (or 75 minutes of

vigorous intensity) aerobic exercise and at least two resistance exercise sessions each

week [9]. Despite a compelling evidence base, exercise is yet to form part of standard

breast cancer care within Australia, and questions regarding the safety, feasibility and

effectiveness of exercise for the wider breast cancer population remain. Specifically,

the generalisability of findings from exercise trials to physically inactive women with

stage II+ disease, who make up 45% of the breast cancer population is unclear [1, 11,

12]. The broad aim of this PhD was to evaluate the safety, feasibility, and effectiveness

of exercise among physically inactive women with stage II+ breast cancer. It was also

an objective to improve understanding of the ways in which physical activity can be

maintained in the longer term. To achieve this, there were four components to this

research: 1) a systematic review and meta-analysis to evaluate the safety, feasibility

and effectiveness of exercise among women with stage II+ breast cancer (Chapter 2);

2) an exploratory data analysis of a previous exercise trial (the Exercise for health

trial), to explore the association between the number of visits of an allied health

professional and improvements in health outcomes (Chapter 2); 3) a 12-week single-

iv Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

group pre-post study to evaluate the safety, feasibility and effectiveness of a 12-week

exercise intervention delivered through a pragmatic supervision model among a

sample of women with stage II+ breast cancer (the SAFE study, Study 1), and; 4) a

12-week RCT to evaluate the effect of a physical activity tracker device on longer-

term physical activity maintenance in physically active women with stage II+ breast

cancer (the SAFE-Maintain study).

The first component of this PhD research involved a systematic review and meta-

analysis to assess exercise safety, feasibility and effectiveness among women with

stage II+ breast cancer. Specifically, the review evaluated: 1) the number of adverse

events (safety); 2) study recruitment, withdrawal and adherence rates (feasibility); and

3) the effect of exercise on various health outcomes including quality of life, aerobic

fitness and fatigue. A total of 61 RCTs that involved samples comprising at least 50%

of women with stage II+ breast cancer was included. Results of the meta-analysis

showed no difference in adverse event risk between the exercise and usual care groups

(risk difference, RD: 0.00 [95% CI=-0.01, 0.01]), p=0.38). Median (minimum,

maximum) recruitment rate was 56% (1, 96%), withdrawal rate was 10% (0, 41%) and

adherence rate was 82% (44, 99%). Meta-analyses of health outcomes showed that

compared with usual care, there were significant effects in favour of exercise for

quality of life, aerobic fitness, muscular strength, anxiety, depression, fatigue, waist

circumference and body mass index (standardised mean difference, SMD, range: 0.17

to 0.77, p<0.05), with supervised interventions being more effective than unsupervised

interventions (p<0.05). Overall, the findings support the safety, feasibility and

effectiveness of exercise in this cohort. However, under the current Australian

Medicare Chronic Disease Management Plan (CDMP), individuals with a chronic

medical condition, including breast cancer, are only eligible for up to five rebatable

supervised exercise sessions with an Accredited Exercise Physiologist (AEP) each

year [13]. It is unclear how five visits have been determined to be an appropriate

number of sessions for the provision of exercise prescription services. Further, the

level of supervision provided as part of the supervised interventions that contributed

to the meta-analyses findings exceeded this level of support (number of supervised

sessions in studies included in the review ranged from eight to 40 sessions). As such,

it is yet to be determined whether the Australian rebatable model of exercise

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer v

supervision from an AEP is safe, feasible and sufficient to achieve clinically relevant

improvements in health outcomes for women with stage II+ breast cancer.

The second component of this PhD research involved an exploratory data

analysis of a previous exercise trial (the Exercise for Health trial [4, 14]) to assess the

association between the number of AEP sessions received during the trial and change

in quality of life, fatigue and aerobic fitness between baseline (six weeks post-breast

cancer diagnosis) and six months post-surgery [4, 14]. Analyses using generalised

estimating equation modelling showed that improvements in quality of life and fatigue

between six weeks and six months post-surgery were significant for those who

received eight or more sessions (mean improvement, quality of life: 5.42 [95%

CI=3.00, 7.85]; fatigue: 2.21 [95% CI=0.48, 3.94]). In contrast, changes in health

outcomes for those who received fewer than eight sessions with an AEP did not reach

the clinically relevant thresholds (quality of life: 3.29 [95% CI= –2.93, 9.53]; fatigue:

0.67 [95% CI= –3.28, 4.63]). Further, those who received fewer than eight sessions

showed greater declines in aerobic fitness during the intervention compared with those

who received eight or more sessions with an AEP, although these findings were not

supported statistically. While these results reflect associations rather than causality,

the findings nonetheless highlight uncertainties about whether five supervised visits

with an allied health professional prescribing exercise as a form of treatment is

sufficient to minimise risk of exercise-related adverse events and whether this level of

contact is sufficient for helping people to become and stay regularly active in the short

and longer-term.

The third component of this PhD research was a 12-week single-group pre-post

study to evaluate the safety, feasibility and effectiveness of a 12-week exercise

intervention delivered through a pragmatic supervision model among a sample of

women with stage II+ breast cancer (the SAFE study, Study 1). The broad aim of this

study was to increase physical activity in this sample through exercise prescription.

Eligibility criteria included having a diagnosis of stage II+ breast cancer; currently

undergoing or have completed breast cancer treatment within the previous five years;

engaging in less than 150 minutes of moderate intensity physical activity per week;

and diagnosis with at least one comorbidity, chronic disease (e.g. hypertension,

osteoporosis or type II diabetes), or breast cancer treatment sequelae (e.g. fatigue).

These eligibility criteria ensured that the subgroup of the breast cancer population who

vi Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

have been least likely to participate in previous exercise trials (but may have the most

to gain from doing so) was specifically targeted. All participants received an

individualised, progressive 12-week home-based exercise program with a weekly

exercise target of 150 minutes of moderate intensity, combined resistance and aerobic

exercise. The intervention involved five face-to-face, supervised exercise sessions

across the 12-week intervention period. Primary outcomes were intervention safety

(evaluated by adverse events resulting from exercise) and feasibility (evaluated by

retention, compliance and adherence), while secondary outcomes included aerobic

fitness, upper and lower body strength, balance, body weight, body composition,

quality of life (and related outcomes) and physical activity levels. Thirty (n=30)

participants consented to participate. There was a total of 45 adverse events

experienced by 18 participants during the 12-week intervention period. Of these, 28

events were exercise-related, with the most common being mild, delayed onset muscle

soreness following exercise (n=7 events). No exercise-related adverse event resulted

in cessation of exercise for two or more weeks; however, approximately one-third of

general events (39%, n=11 events in eight participants) resulted in exercise

modification, such as lowering of exercise intensity, duration or frequency or

substitution of a particular exercise. Results also showed that retention (90%),

adherence to supervised sessions (87%) and compliance to the exercise prescription

(83% of the weekly target) were high. Adherence to unsupervised exercise sessions

was lower (68%). Due to individual circumstances, four (13%) participants had a

weekly prescription that was purposely less than the target, while two participants

(7%) never met the weekly target. Over half (59%) of participants met the intervention

weekly target >75% of the time, and at 12 weeks most participants (85%, n=23) were

performing at least 150 minutes of moderate intensity physical activity. The

intervention was also associated with clinically relevant improvements in aerobic

fitness, upper body strength, quality of life, functional wellbeing, physical health,

physical function, depression, fatigue and satisfaction with social roles and physical

activity (all p<0.05). Overall, key findings from the SAFE study were that (1) an

exercise intervention delivered in accordance with the level of supervision provided

under the current Medicare CDMP was implemented safely and feasibly, and (2)

participating in the intervention was associated with mean improvements in various

health-related outcomes. However, given that a substantial proportion (41%) of the

sample was unable to meet physical activity recommendations at least 75% of the time

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer vii

and that between 4 and 54% either reported no change or declines in health outcomes

following the intervention period, these findings highlight the importance of an

individualised, exercise prescription approach, including a need for flexibility in the

provision of support for AEP services for this population.

The objective of the final part of this PhD research was to evaluate the effect of

a physical activity tracker device on longer-term physical activity maintenance in

physically active women with stage II+ breast cancer (the SAFE-Maintain study). That

is, while SAFE (study 1) was designed to increase physical activity levels, SAFE-

Maintain (study 2) was designed to evaluate effect of strategies on maintainence of

physical activity levels in this sample. The trial was a 12-week RCT (n=52), with

random allocation to a physical activity counselling session with an AEP and provision

of a physical activity booklet (PAC group, n=26) or to a physical activity counselling

session and provision of a physical activity booklet, plus a physical activity tracker (a

Fitbit) to wear and use for the 12-week follow-up period (PAC+F group, n=26).

Results showed trends for higher objectively-assessed, moderate-to-vigorous physical

activity (MVPA, p=0.09) and steps per day (p=0.07) in the PAC+F group compared

with the PAC group at the 12-week follow-up, although results were not supported

statistically. The PAC group showed reductions in moderate-intensity physical activity

(mean change: –45.8 [95% CI: –83.7, –7.8] minutes per week, p=0.01) and total

activity (mean change: –94.4 [95% CI: –177.4, –11.3] minutes per week, p=0.02) over

the 12 weeks, while no changes were observed in the PAC+F group (p>0.05). At the

12-week follow-up, the PAC+F group was performing a higher amount of total

activity, compared with the PAC group (between-group mean difference: 112.2 [95%

CI=12.5, 211.8], p=0.02). No significant group by time interactions were observed for

overall quality of life assessed using the FACT-G (p>0.05); however, the PAC group

showed a clinically relevant reduction in overall quality of life (mean change: –6.0

[95% CI= –12.2, 0.1]). Feasibility data indicated that the Fitbit was easy to use and

comfortable to wear. Participants were satisfied overall with how the device assisted

them to keep physically active, and most (96%) reported they would continue to use a

physical activity tracker in the future. In summary, the key findings from the SAFE-

Maintain study were that physical activity trackers (in addition to physical activity

counselling from an AEP) may be a feasible, cost-effective, accessible and scalable

strategy to promote longer-term physical activity in this population.

viii Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

Overall, the findings from this PhD research have important clinical and public

health implications. This work supports that exercise delivered in accordance with the

current funding model of AEP supervision is associated with safe, feasible and

effective exercise participation among physically inactive women with stage II+ breast

cancer who have a high disease burden. Moreover, AEPs may implement

complementary strategies (such as physical activity trackers) to help women with stage

II+ breast cancer who have recently become sufficiently active to maintain longer-term

physical activity (and associated health benefits). However, this work also highlights

the need for individualised and targeted exercise and physical activity advice. This

advice will require AEPs to use a combination of evidence, alongside clinical

knowledge and experience to help women become and stay sufficiently active in the

short and longer-term. This will allow AEPs to recognise who responds to exercise

(and to what extent), whether the focus of their service provision should be on exercise

prescription or behaviour change advice and support, and whether additional tools and

strategies are needed to help optimise the benefits that women can gain through

exercise and physical activity.

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer ix

Table of Contents

Keywords .................................................................................................................................. i

Abstract ................................................................................................................................... iii

List of Figures ....................................................................................................................... xiv

List of Tables ..........................................................................................................................xv

List of Abbreviations ........................................................................................................... xvii

Statement of Original Authorship ....................................................................................... xviii

Acknowledgements ............................................................................................................... xix

Chapter 1: Introduction .................................................................................... 21

1.1 Breast cancer in Australia and worldwide ....................................................................21

1.2 Breast cancer treatment .................................................................................................23 1.2.1 Surgery ...............................................................................................................23 1.2.2 Radiotherapy ......................................................................................................24 1.2.3 Chemotherapy ....................................................................................................24 1.2.4 Hormone therapy ................................................................................................25 1.2.5 Targeted therapy .................................................................................................25

1.3 Treatment and disease stage .........................................................................................26

1.4 Common treatment-related side effects following breast cancer diagnosis ..................27 1.4.1 Overview ............................................................................................................27 1.4.2 Fatigue, weight gain and reduced aerobic fitness ...............................................28 1.4.3 Upper body morbidity ........................................................................................29 1.4.4 Comorbidities at time of breast cancer diagnosis ...............................................30 1.4.5 Comorbidities following breast cancer diagnosis and treatment ........................30 1.4.6 Early versus late-stage breast cancer ..................................................................31 1.4.7 Reduced physical activity participation following breast cancer diagnosis .......31

1.5 Benefits of exercise following breast cancer diagnosis ................................................33 1.5.1 Overview ............................................................................................................33 1.5.2 Effect of exercise on health outcomes and subsequent chronic disease risk ......33 1.5.3 Survival benefits of exercise ..............................................................................33 1.5.4 Limitations of current evidence ..........................................................................34

1.6 Physical activity and breast cancer stage ......................................................................35

1.7 Summary .......................................................................................................................36

1.8 Thesis outline ................................................................................................................36

1.9 Contribution to the studies and the broader program of research within which this

work sits ..................................................................................................................................38

Chapter 2: The safety, feasibility and effectiveness of a translational exercise

intervention for women with stage II+ breast cancer (Study 1, the SAFE study)

39

2.1 Chapter overview ..........................................................................................................39

2.2 Literature review part one: systematic review and meta-analysis ................................39 2.2.1 Background ........................................................................................................39 2.2.2 Purpose ...............................................................................................................40 2.2.3 Methods ..............................................................................................................40 2.2.4 Results ................................................................................................................41

x Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

2.2.5 Overview of key findings .................................................................................. 41 2.2.6 Lack of adverse event reporting ......................................................................... 42 2.2.7 Limited representativeness of samples .............................................................. 42 2.2.8 Lack of post-intervention follow-up .................................................................. 43 2.2.9 Limited ability to translate findings into clinical practice ................................. 43 2.2.10 Summary direction for future work ................................................................... 44

2.3 Literature review part two: evaluation of the association between number of

supervised exercise sessions and changes in health outcomes ............................................... 44 2.3.1 Background ........................................................................................................ 44 2.3.2 Secondary data analysis ..................................................................................... 45 2.3.3 Limitations and potential implications of these findings ................................... 46

2.4 Direction for future study ............................................................................................. 47

2.5 The SAFE study (Study 1) ........................................................................................... 48 2.5.1 Aim 48 2.5.2 Hypotheses ......................................................................................................... 48 2.5.3 Ethical approval and informed consent.............................................................. 49 2.5.4 Methods ............................................................................................................. 49 2.5.4.1 Eligibility criteria ............................................................................................ 49 2.5.4.2 Recruitment ..................................................................................................... 51 2.5.4.3 Blinding ........................................................................................................... 53 2.5.4.4 Intervention ..................................................................................................... 53 2.5.4.5 Delivery and location of supervised sessions .................................................. 56 2.5.4.6 Scheduling of supervised sessions .................................................................. 56 2.5.4.7 Role of the AEP during the supervised sessions ............................................. 57 2.5.4.8 Structure and content of supervised session 1 ................................................. 57 2.5.4.9 Structure and content of supervised sessions 2 to 5 ........................................ 59 2.5.4.10 Exercise logbooks ...................................................................................... 60 2.5.4.11 Data collection ........................................................................................... 61 2.5.4.12 Outcomes of interest .................................................................................. 61 2.5.4.13 Secondary outcomes .................................................................................. 63 2.5.4.14 Exploratory outcome .................................................................................. 68 2.5.4.15 Sample size ................................................................................................ 68

2.6 Data management and quality control .......................................................................... 68

2.7 Statistical analysis ........................................................................................................ 69

2.8 Results .......................................................................................................................... 71 2.8.1 Participant flow .................................................................................................. 71 2.8.1.1 Baseline characteristics ................................................................................... 73 2.8.1.2 Safety............................................................................................................... 76 2.8.1.3 Feasibility outcomes ........................................................................................ 78 2.8.1.3.1 Retention .................................................................................................... 78 2.8.1.3.2 Adherence .................................................................................................. 78 2.8.1.3.3 Compliance ................................................................................................ 79 2.8.1.3.4 Summary of feasibility outcomes ............................................................... 83 2.8.1.4 Secondary outcomes ........................................................................................ 84 2.8.1.5 Exploratory outcome ....................................................................................... 93

2.9 Discussion .................................................................................................................... 94 2.9.1.1 Primary outcomes ............................................................................................ 94 2.9.1.2 Safety (adverse events).................................................................................... 94 2.9.1.3 Feasibility ........................................................................................................ 96 2.9.1.4 Retention ......................................................................................................... 96 2.9.1.5 Compliance ..................................................................................................... 97 2.9.1.6 Secondary outcomes ........................................................................................ 99

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer xi

2.9.2 Exploratory outcome ........................................................................................102 2.9.2.1 Barriers to exercise ........................................................................................102

2.10 Limitations ..................................................................................................................103

2.11 Strengths .....................................................................................................................104

2.12 Clinical Implications ...................................................................................................104

2.13 Summary .....................................................................................................................106

Chapter 3: The effect of a physical activity counselling session plus a Fitbit

versus physical activity counselling alone on physical activity maintenance

(Study 2, the SAFE-Maintain study) .................................................................... 109

3.1 Chapter overview ........................................................................................................109

3.2 Literature review .........................................................................................................109 3.2.1 Introduction ......................................................................................................109 3.2.2 Behaviour change techniques ...........................................................................110 3.2.3 The Social Cognitive Theory (SCT) .................................................................111 3.2.4 Transtheoretical Model (TTM) .........................................................................112 3.2.5 The Theory of Planned Behaviour (TPB).........................................................113 3.2.5.1 The TPB and physical activity maintenance among women with breast

cancer................................................................................................................116 3.2.5.2 Comparison between models .........................................................................116 3.2.5.3 Use of behaviour change models in the development of SAFE ....................117 3.2.5.4 Pedometers .....................................................................................................118 3.2.5.4.1 Pedometers to facilitate self-monitoring and goal-setting ........................118 3.2.5.5 Consumer-based physical activity trackers ....................................................119 3.2.5.6 Consumer-based physical activity trackers and behavior change

techniques .........................................................................................................120 3.2.5.7 Feasibility and effectiveness of Fitbits ..........................................................120 3.2.5.7.1 Feasibility .................................................................................................121 3.2.6 Physical activity following breast cancer .........................................................122 3.2.6.1 Post-intervention physical activity maintenance among women with

breast cancer .....................................................................................................123 3.2.7 Summary of key points .....................................................................................124

3.3 Background to Study 2 ...............................................................................................125

3.4 Study overview, design and aim .................................................................................125

3.5 Ethical approval and informed consent ......................................................................125

3.6 Hypothesis ..................................................................................................................125

3.7 Secondary objectives ..................................................................................................126

3.8 Exploratory objective..................................................................................................126 3.8.1 Feasibility .........................................................................................................126 3.8.2 Acceptability ....................................................................................................127

3.9 Methods ......................................................................................................................127 3.9.1 Setting ...............................................................................................................127 3.9.2 Inclusion criteria ...............................................................................................127 3.9.3 Exclusion criteria ..............................................................................................127 3.9.4 Recruitment ......................................................................................................128 3.9.5 Physical activity counselling session and intervention booklet ........................128 3.9.6 Booklet development and components .............................................................129 3.9.7 Physical activity counselling session (received by PAC and PAC+F

groups) ..............................................................................................................129

xii Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

3.9.8 Provision of a Fitbit (received by PAC+F group only) .................................... 130 3.9.9 Data collection and blinding ............................................................................ 131 3.9.10 Primary outcome .............................................................................................. 131 3.9.10.1 Self-reported physical activity ................................................................. 131 3.9.10.2 Objectively-measured physical activity ................................................... 132 3.9.11 Secondary outcomes ........................................................................................ 133 3.9.12 Exploratory outcome: Fitbit feasibility and acceptability ................................ 134 3.9.12.1 Feasibility ................................................................................................. 134 3.9.12.2 Acceptability ............................................................................................ 135 3.9.13 Sample size ...................................................................................................... 135 3.9.14 Statistical analysis ............................................................................................ 136 3.9.15 Data management and quality control ............................................................. 137

3.10 Results ........................................................................................................................ 138 3.10.1 Participant flow ................................................................................................ 138 3.10.2 Participant baseline characteristics .................................................................. 140 3.10.3 Primary outcome: physical activity levels ....................................................... 144 3.10.3.1 Secondary outcomes: ............................................................................... 149 3.10.4 Fitbit feasibility ................................................................................................ 154 3.10.4.1 Summary of Fitbit feasibility and acceptability results ............................ 156

3.11 Discussion .................................................................................................................. 157 3.11.1 Overview of key findings ................................................................................ 157 3.11.2 Primary outcomes (physical activity) .............................................................. 157 3.11.2.1 Comparison to similar studies .................................................................. 158 3.11.2.2 Secondary outcomes ................................................................................ 158 3.11.2.3 Exploratory outcomes: Fitbit feasibility and acceptability ...................... 159 3.11.3 Barriers and dislikes......................................................................................... 162

3.12 Study limitations and strengths .................................................................................. 163

3.13 Clinical implications and summary ............................................................................ 165

Chapter 4: Future research and conclusions ................................................. 168

4.1 SAFE .......................................................................................................................... 168

4.2 SAFE-Maintain .......................................................................................................... 170

4.3 Overall summary ........................................................................................................ 171

Bibliography ........................................................................................................... 173

Appendices .............................................................................................................. 197

4.4 Appendix A: Systematic review and meta-analysis manuscript ................................ 198

4.5 Appendix B. Results tables from the secondary data analyses of Section 2.3. .......... 239

4.6 Appendix C: Copy of the published commentary article from the secondary analyses

of Section 2.3. ....................................................................................................................... 243

4.7 Appendix D: Telephone screening questionnaire ...................................................... 247

4.8 Appendix E: Case management folder (used by the exercise physiologist) .............. 255

4.9 Appendix F: Participant exercise logbook ................................................................. 270

4.10 Appendix G: Data collection sheet ............................................................................ 273

4.11 Appendix H: Summary of statistical tests used for each outcome ............................. 275

4.12 Appendix I: Log of all adverse events ....................................................................... 277

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer xiii

4.13 Appendix J: Box plots showing median and interquartile ranges of minutes per week

of moderate intensity aerobic and resistance exercise (Rating of Perceived Exertion: 12 to

14) that was performed during each of the 12 weeks ............................................................280

4.14 Appendix K: Physical activity counselling booklet (“Staying active after SAFE”) ...281

4.15 Appendix L. Overview of the theory of planned Behaviour constructs and summary of

how they were implemented into the booklet (“staying active after SAFE”) .......................289

4.16 Appendix M. DESCRIPTION of the booklet components and Theory Planned

Behaviour constructs that each component addressed. .........................................................291

4.17 Appendix N: Fitbit feasibility questionnaire ..............................................................293

4.18 Appendix O: Detailed Fitbit feasibility results ...........................................................300

xiv Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

List of Figures

Figure 1.1 Overview of the Safety and Feasibility of Exercise (SAFE) studies. ...... 37

Figure 2.1 Study CONSORT flow diagram ............................................................... 72

Figure 2.2 Individual participant plots of minutes of moderate intensity aerobic

and resistance exercise (Rating of Perceived Exertion: 12 to 14) that

was performed during each of the 12 weeks ................................................ 81

Figure 2.3 Mean (standard deviation) minutes per week of moderate intensity

aerobic and resistance exercise (Rating of Perceived Exertion 12 to

14) that was performed during each of the 12 weeks. ................................. 82

Figure 3.1 Social Cognitive Theory and physical activity behaviour. Adapted

from "Health Promotion by Social Cognitive Means", by S. Bandura,

2004, Health Education & Behavior, 3 (12), p.143. Copyright 2004 by

SAGE ......................................................................................................... 112

Figure 3.2 Theory of Planned Behaviour and its components. Adapted from

"Behavioural reasoning theory: Identifying new linkages underlying

intentions and behavior", by J. Westaby, 2005, Organizational

Behavior and Human Decision Processes, 98 (2), p.97. Copyright

2018 by Elsevier B.V. [227]. ..................................................................... 114

Figure 3.3 CONSORT participant flow diagram ..................................................... 139

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer xv

List of Tables

Table 1.1 Breast cancer stages ................................................................................. 22

Table 1.2 Common treatment options for the different stages of breast cancer ........ 27

Table 2.1 Summary of eligibility criteria ................................................................... 50

Table 2.2 Example of supervised intervention delivery and integration of five

supervised sessions ...................................................................................... 54

Table 2.3 Examples of scheduling of sessions of resistance and aerobic

exercise during the 12-week intervention .................................................... 55

Table 2.4 An example of an individualised exercise prescription with target

weekly dose of 150 weekly minutes of moderate+ intensity exercise

during the 12-week intervention .................................................................. 56

Table 2.5 Summary of the structure of supervised session 1 ..................................... 57

Table 2.6 Education content covered during supervised session 1 ........................... 58

Table 2.7 Summary of the structure of supervised sessions 2 to 5 ............................. 59

Table 2.8 Overview of the education content covered by the AEP during the 12-

week intervention ......................................................................................... 60

Table 2.9 Overview of all secondary outcomes ......................................................... 64

Table 2.10 Participant baseline characteristics (n=30) ............................................ 74

Table 2.11 Adverse events separated by grade of severity described as exercise

and non-exercise-related ............................................................................. 77

Table 2.12 Adherence to participating in the supervised exercise sessions

during the 12-week intervention .................................................................. 78

Table 2.13 Adherence to prescribed exercise sessions, presented as weekly

sessions and total number of prescribed sessions during the

intervention .................................................................................................. 79

Table 2.14 Summary of feasibility outcomes.............................................................. 83

Table 2.15 Change in fitness, strength, balance, bodyweight and body mass

index between pre- and post-exercise intervention ...................................... 85

Table 2.16 Change in quality of life (FACT-G) outcomes between pre- and

post-exercise intervention ............................................................................ 87

Table 2.17 Change in PROMIS questionnaire results between pre- and post-

exercise intervention .................................................................................... 88

Table 2.18 Change in exercise self-efficacy between baseline and post-

intervention .................................................................................................. 89

Table 2.19 Minutes per week of self-reported physical activity at baseline and

12 weeks ....................................................................................................... 90

Table 2.20 Proportions meeting physical activity guidelines at baseline and 12-

weeks ............................................................................................................ 91

xvi Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

Table 2.21 Proportions of participants that showed a clinically relevant

improvement, no change or worsening in secondary outcomes .................. 92

Table 2.22 Barriers to exercise, separated as health or medical-related and

non-health or medical-related reasons ........................................................ 93

Table 3.1 Participant baseline characteristics ........................................................ 141

Table 3.2 Comparison of objectively-assessed physical activity at the 12-week

follow-up between PAC and PAC+F ......................................................... 144

Table 3.3 Self-reported physical activity (minutes per week) at baseline and 12-

week follow-up between the PAC and PAC+F groups .............................. 146

Table 3.4 Proportion of participants meeting physical activity guidelines at

baseline (self-report) and 12 weeks (self-report and objectively

assessed) ..................................................................................................... 147

Table 3.5 Proportion of participants that either increased, did not change or

decreased physical activity between baseline and 12 weeks ..................... 148

Table 3.6 Quality of life (FACT-G and subscales) scores are baseline, 12

weeks and change scores between intervention and control groups ......... 150

Table 3.7 Quality of life (PROMIS-43 and all subscale, PROMIS Global short-

form and PROMIS Upper-Extremity) scores at baseline, 12 weeks and

change scores between intervention and control groups ........................... 151

Table 3.8 Exercise self-efficacy between baseline and 12 weeks for intervention

and control groups ..................................................................................... 154

Table 3.9 Summary of Fitbit feasibility and acceptability outcomes with respect

to study objectives ...................................................................................... 156

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer xvii

List of Abbreviations

AEP: Accredited Exercise Physiologist

BMI: Body mass index

CDMP: Chronic Disease Management Plan

CI: Confidence interval

CTC-AE: Common Terminology Criteria for Adverse Events

FACT-B: Functional Assessment of Cancer Therapy-Breast

FACT-G: Functional Assessment of Cancer Therapy-General

HR: Hazard ratio

MVPA: Moderate-to-vigorous intensity physical activity

OR: Odds ratio

PAC: Physical activity counselling group

PAC+F: Physical activity counselling plus Fitbit group

PEDro: Physiotherapy Evidence Database

PROMIS: Patient-Reported Outcomes Measurement Information System

RCT: Randomised controlled trial

RD: Risk difference

RR: Relative risk

SD: Standard deviation

SEER: The Surveillance, Epidemiology, and End Results program

SIR: Standardised incidence ratio

SMD: Standardised mean difference

WMES: Weighted mean effect size

xviii Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer

Statement of Original Authorship

The work contained in this thesis has not been previously submitted to meet

requirements for an award at this or any other higher education institution. To the best

of my knowledge and belief, the thesis contains no material previously published or

written by another person except where due reference is made.

Signature:

Date: February 2019

QUT Verified Signature

Exercise safety, feasibility and the role of Fitbits among women with stage II+ breast cancer xix

Acknowledgements

Professor Sandi Hayes

Dr. Rosa Spence

Dr. Jonathan Peake

Scholarship: Research Training Program (Stipend) Domestic (RTP)

I acknowledge the services of professional editors, who provided copyediting and

proofreading services, according to the guidelines laid out in the university endorsed

national ‘Guidelines for editing research theses’.

Chapter 1: Introduction 21

Chapter 1: Introduction

1.1 BREAST CANCER IN AUSTRALIA AND WORLDWIDE

Breast cancer is the most common cancer among women worldwide [11].

Approximately 1.7 million women are diagnosed yearly, which represents 12% of all

new cancer cases and 25% of all cancers in women [11]. In Australia, breast cancer

accounts for 28% of all new cancer diagnoses [1]. It is the most common cancer among

women, with one in eight women diagnosed prior to the age of 85 [1]. The incidence

of breast cancer is increasing, with 14,181 new cases being diagnosed in 2010, and

17,200 new cases in 2017 [15, 16]. Most recently obtained national data indicated that

in 2012 there were 66,000 people living with breast cancer in Australia who had been

diagnosed in the previous five years (from 2008 to 2012), and 193,730 people who had

been diagnosed in the previous 10 years (from 1982 to 2012) [15]. Breast cancer is

also the second leading cancer-related cause of death among women in Australia [1,

15, 17]. Nonetheless, due to improved screening and treatment, women with breast

cancer are living significantly longer [18]; between 2006 and 2010, the five-year

relative survival for women with breast cancer in Australia was 89%, compared to

72% between the years 1982 and 1987 [1].

Breast cancer is classified into stages. Each stage is dependent on tumour size,

the number of affected lymph nodes, and whether the cancer has spread (or

metastasised) to other parts of the body [19]. A detailed overview of the different

stages is shown in Table 1.1. Stage 0 represents breast cancer that is typically detected

early, whereby the cancer cells are confined to the breast ducts or glands and there is

no evidence that the cancer cells have spread beyond the site where they originated, or

that they have invaded surrounding breast tissue (i.e. non-invasive breast cancer) [19-

21]. In stage I, the tumour is two centimetres or less in diameter and the cancer cells

have not spread outside of the part of the breast where they originated, or invaded

surrounding lymph nodes [20, 21]. In stage II, the tumour is between two and five

centimetres and/or has spread more extensively to the axillary (i.e. armpit) lymph

nodes, with up to three lymph nodes affected [19-21]. Stage II is further categorised

as IIA or IIB, depending on tumour size and lymph node involvement. In stages IIIA

to C, there is evidence that the cancer has spread beyond the breast tissue and invaded

22 Chapter 1: Introduction

surrounding tissues such as the chest wall or skin of the breast, which in turn signifies

‘advanced’ cancer [19-21]. In stage IV, the cancer has metastasised beyond the breast

to other parts of the body such as the skin, bones, lungs, distal lymph nodes, brain,

liver, or other organs [19-21].

Table 1.1

Breast cancer stages

Stage Size of cancer Lymph node involvement

Has the cancer

spread to other

parts of the

body?

0 Size not used for stage 0 0 No

I <2 cm 0 No

IIA <2 cm 1 to 3 axillary lymph nodes No

2 to 5 cm 0

No cancer found in breast 1 to 3 axillary lymph nodes

IIB 2–5 cm 1 to 3 axillary lymph nodes No

>5 cm 0

IIIA <2 cm 4 to 9 axillary lymph

nodes1

No

2 to 5 cm 4 to 9 axillary lymph

nodes1

>5 cm 1 to 3 axillary lymph nodes

>5 cm 4 to 9 axillary lymph

nodes1

No cancer found in breast 4 to 9 axillary lymph

nodes1

IIIB Any size but the cancer has

spread to nearby muscles

and skin

>0 No

IIIC Any size >10 axillary lymph nodes1 No

IV Any size >0 Yes 1 Or >1 or lymph nodes under the breastbone or collarbone

Note. Adapted from Stages of Breast Cancer. Copyright 2018 by Cancer Australia

[19].

Among Queensland women diagnosed with breast cancer between 2002 and

2006, 47% had stage I breast cancer and 45% were diagnosed with stage II to IV (8%

were unknown) [2]. Of note, national data in relation to the stage of diagnosis are

currently not collected systematically across Australia [22]. Therefore, more recent

Australian data on the proportion of women diagnosed by stage are not presently

available. Recently obtained international data from the United Kingdom indicated

that, in 2015, 40% of breast cancer diagnoses were stage I, 38% were stage II, 14%

were stage III to IV and 7% were unknown [23]. Up to 10% of women will initially be

diagnosed with stage IV (metastatic) disease and approximately one-third who are


treated for stage I to II disease will progress to stage IV disease [24, 25]. Queensland

data indicates that the five-year relative survival for women with stage I disease is 98%

[2]. In contrast, for women diagnosed with stages II to IV breast cancer, the five-year

relative survival is lower (83% overall [1, 2]), with international data indicating rates

as low as 49% for stage IIIC [26], and 26% for women with distant metastases at

diagnosis [27].

1.2 Breast cancer treatment

Treatment options for breast cancer are determined by factors such as breast

cancer type, disease stage, and patient characteristics. Treatment for breast cancer

typically includes surgery with or without radiation, chemotherapy, hormone therapy

and/or targeted therapy. Surgery and radiation therapy are local treatments, where the

treatment specifically targets the cancer site (e.g. surgery or radiation to the breast or

chest region). Chemotherapy, hormone and targeted therapies are systemic treatments

[28]. Systemic treatments are drug treatments that are administered either orally or

directly into the bloodstream (intravenously) [28]. Once administered into the

circulatory system, the drugs can reach and act on cancer cells to prevent the growth

or reduce the risk of recurrence of breast cancer [28]. The types and extent of treatment

that each patient receives vary and depend on factors such as breast cancer stage and

type, including hormone receptor status, genetic factors (such as the presence of known

mutations in inherited breast cancer genes), as well as the patient’s age, menopausal

status, general health, and individual preferences [29]. Overall, Australian data

indicate that 35% of women with stage I to IV breast cancer receive a mastectomy,

65% receive a lumpectomy, 41% receive chemotherapy, 75% receive radiation therapy

and 58% receive hormonal therapy [30].

1.2.1 Surgery

Most women (>90% [31]) receive some form of surgery as component of their

treatment. Depending on patient and disease characteristics, surgery may be performed

to remove the cancer, or remove as much of as possible (breast-conserving surgery or

a mastectomy), to investigate if the cancer has spread to the axillary lymph nodes, to

restore the shape of the breast after the cancer has been removed (breast

reconstruction), or to help improve symptoms of advanced cancer such as pain [32].

The two major forms of surgery to treat breast cancer are breast-conserving surgery


and a mastectomy. Breast-conserving surgery, also referred to as a lumpectomy or a

partial mastectomy, is a procedure where only the section of the breast containing the

cancer, and a small amount of unaffected surrounding tissue, is removed [32]. This

surgery is usually recommended for women with early-stage breast cancer, or if a

patient has a small tumour (5 centimetres or less) [29]. A mastectomy represents more

extensive breast surgery, whereby the entire breast is removed, including most or all

of the lymph nodes in the axillary region of the affected side [32]. A mastectomy is

usually recommended if there is more than one tumour in the breast or if a patient has

a large tumour (greater than 5 centimetres) [29]. A double (or bilateral) mastectomy

may be performed when a patient has bilateral disease, or as preventive surgery if the

patient is considered at high-risk of having a cancer recurrence in the opposite breast;

for example, due to genetic factors [29, 32].

1.2.2 Radiotherapy

Radiotherapy uses high-energy rays to kill cancer cells that may be remaining in

the breast or axillary region after surgery [32]. Treatment with radiation depends on

factors such as type of surgery, whether the cancer has spread to the lymph nodes or

other parts of the body, and age [33]. It is usually recommended following breast-

conserving surgery and sometimes following a mastectomy to reduce the risk of

recurrence or spread [33]. The two main types of radiotherapy used to treat cancer are

external beam radiation (this type of radiation is administered from a machine external

to the body) and internal radiation (i.e. brachytherapy, where a radioactive source, such

as a pellet, is temporarily inserted inside the body) [28, 29]. External beam radiation

is the most common form of radiation treatment for women with breast cancer [29].

The radiation is administered to the area affected by the cancer (i.e. to the chest wall

or axillary region) [28, 29]. Treatment with radiotherapy is usually administered five

days a week for five to six weeks [29].

1.2.3 Chemotherapy

Chemotherapy is treatment with one or more cytotoxic (i.e. cancer-killing) drugs

that are administered either orally or intravenously [32]. The drugs enter and travel in

the bloodstream to act on cancer cells in most parts of the body to minimise the growth

of cancer cells, or risk of recurrence of breast cancer [29, 33]. Chemotherapy drugs act

by destroying fast-growing cells in the body, such as cancer cells. Normal healthy cells

which are fast growing (e.g. in the mouth, stomach, bowel, skin, hair and bone marrow)


also are affected but may repair over time [32]. Chemotherapy may be recommended

before (neoadjuvant chemotherapy) or after surgery (adjuvant chemotherapy) [33].

The aim of neoadjuvant chemotherapy is to shrink the tumour, so that it can then be

removed with less extensive surgery, or to treat cancers that are too large for surgical

removal at the time of diagnosis [29, 33]. Adjuvant chemotherapy is usually

recommended following surgery to kill any remaining or undetectable cancer cells, or

cancer cells that have spread to other parts of the body to reduce the risk of breast

cancer recurrence and metastasis [29, 33]. Due to the toxic effects of the drugs,

chemotherapy is typically administered in cycles, with treatment cycles followed by a

recovery period. Depending on the specific drugs that are administered, their

effectiveness and side effects that a patient experiences, each cycle is usually two to

three weeks in duration, for a total of three to six months [29, 33].

1.2.4 Hormone therapy

Hormone therapy is a systemic treatment used for several types of breast cancer

[32]. Approximately three in four breast cancers are sensitive to the female hormones

oestrogen and progesterone, meaning these naturally occurring hormones help breast

cancer cells to grow and spread [29]. These are called hormone receptor-positive breast

cancers [32]. Hormone therapy drugs use various mechanisms to stop the growth of

cancer cells by either lowering estrogen levels, or inhibiting estrogen from acting on

breast cancer cells [29, 34]. Hormone therapy may also be used as treatment for cancer

that has returned following initial treatment, or to treat cancer that has spread to other

parts of the body [29]. Hormone therapy is most often used following surgery (as

adjuvant therapy) to help reduce the risk of cancer recurrence, but may also be

recommended before surgery (as neoadjuvant treatment) [34]. Patients are usually

placed on hormone therapy for at least five years [34]. Common hormone therapy

drugs include Tamoxifen (this drug blocks estrogen receptors in the breast cancer cells)

and aromatase-inhibiting drugs, which inhibit estrogen production [29, 33].

1.2.5 Targeted therapy

Targeted therapy is a therapy involving drugs that specifically inhibit the growth

and spread of cancer cells, without harming healthy non-cancer cells (unlike

chemotherapy, which targets cancer cells and healthy non-cancer cells) [32]. As a

result, targeted drugs often lead to less severe side effects than chemotherapy, and are

used to treat early- to late-stage breast cancer [29]. Targeted therapy is typically used


in combination with other treatments, such as radiation therapy, chemotherapy or

surgery, or may be used alone if other treatments have been ineffective [35]. A

common targeted therapy drug is Trastuzumab (Herceptin), which is used to treat

early- to late-stage breast cancer. When commenced before or after surgery in early-

stage breast cancer, this treatment is normally prescribed for a total of one year [36].

For patients with metastatic breast cancer, it can also be administered for as long as

the patient experiences benefit from the treatment, as longer-term treatment option

[36].

1.3 TREATMENT AND DISEASE STAGE

Treatment options for the different stages of breast cancer are shown in Table

1.2 [37-39]. There are no current Australian statistics available for describing

treatment by stage of disease. International (United States) data indicate that among

women with stage I to II breast cancer, 59% receive breast-conserving surgery (a

lumpectomy), 36% receive a mastectomy, 62% receive radiation therapy and 40%

receive chemotherapy (including targeted therapy and immunotherapy drugs) [40]. In

comparison, among women with stage III to IV breast cancer, 13% receive breast-

conserving surgery, 59% receive a mastectomy, 75% receive radiation therapy, and

74% receive chemotherapy (including targeted therapy and immunotherapy drugs)

[40]. Further, combined mastectomy, radiation therapy and chemotherapy is received

by 6% of women with stage I to II and 36% of women with stage III to IV [40]. Overall,

compared with women with stage I to II disease (36%), greater proportions of women

with stage III to IV disease (59%) receive more extensive surgery (i.e. a mastectomy

rather than breast-conserving surgery), with more having this surgery combined with

multiple adjuvant treatments (stage I to II: 6%; stage III to IV: 36%) [40].


Table 1.2

Common treatment options for the different stages of breast cancer

Stage Treatment

I • Mastectomy (radiation therapy after mastectomy only rarely needed)

• Lumpectomy plus radiation therapy, or very occasionally lumpectomy alone without

radiation therapy

• Chemotherapy

• Hormonal therapy

• Targeted therapy

II • Mastectomy (radiation therapy after mastectomy may be needed)

• Lumpectomy plus radiation therapy.

• Chemotherapy (commonly recommended)



III IIIA and Operable IIIC:

• Mastectomy followed by radiation therapy

• Lumpectomy plus radiation therapy following chemotherapy

• Chemotherapy (almost always recommended)


• Targeted (endocrine) therapy

IIIB and Inoperable IIIC:

• Chemotherapy followed by mastectomy and radiation




IV • Surgery, radiation therapy, or both




Note. Adapted from “Breast cancer overview: current treatments”, by B. Blowers and

S. Foy, 2009, Practice Nursing, 20(6), p. 282. Copyright 2018 by MA Healthcare

Limited [37]; “Treatment Options by Cancer Stage” from Breastcancer.org.

Copyright 2018 by 2018 Breastcancer.org [39].

1.4 COMMON TREATMENT-RELATED SIDE EFFECTS FOLLOWING

BREAST CANCER DIAGNOSIS

1.4.1 Overview

There are significant physical and psychosocial side effects associated with

breast cancer and its treatment, many of which can persist for years after completion

of treatment [30, 41-43]. Observational evidence indicates that breast cancer

treatments are associated with: fatigue, reduced fitness (aerobic fitness and muscular

strength) and physical function; upper body morbidity (including pain, weakness,


stiffness, numbness, poor range of motion and lymphoedema); impaired cardiac

function, increased body fat, and reduced lean body mass (muscle wasting); cognitive

impairment, depression, anxiety, negative effects on body image and self-perceptions;

an increased risk of development of comorbidities, and reduced overall quality of life

[30, 41-48]. Findings from a prospective, cohort study of a representative sample of

287 women with breast cancer reported that six months following diagnosis, 90% of

women experience at least one significant adverse treatment-related effect (including

fatigue, pain, weight gain and lymphoedema), with three in five of these women

reporting multiple side effects [49]. Beyond 12 months following diagnosis,

continuing treatment-related effects are reported by 60 to 70% of women [49].

1.4.2 Fatigue, weight gain and reduced aerobic fitness

Fatigue is one of the most common and debilitating adverse treatment-related

effects [50]. Up to 94% of breast cancer patients experience fatigue at some point

following diagnosis [51], with 26% and 16% of women continuing to experience

fatigue six months and six years after completing treatment, respectively [49]. Weight

gain is also common among women with breast cancer. Up to 84% of women gain

weight after a breast cancer diagnosis [52, 53], with average gains in weight ranging

between 2.5 to 5.2 kilograms during the treatment period [42, 54, 55]. Breast cancer

survivors also experience reductions in physical fitness and function at faster rates

compared with normal age-related reductions [56]. Aerobic fitness is an important

indicator of physical fitness, function and all-cause mortality [57]. During a typical

12-week period of chemotherapy treatment, reductions in aerobic fitness of between

10 and 33% have been reported in prospective trials [58-61]. Further, evidence from a

cross-sectional study indicates that compared with age-matched sedentary women

without a history of breast cancer, aerobic fitness is 31% lower in newly diagnosed

untreated patients before receipt of surgery and adjuvant therapy (i.e. before

treatment), 31% lower in patients receiving adjuvant chemotherapy (i.e. during

treatment), 22% lower among survivors six months to three years post-treatment (i.e.

after treatment) and 33% lower among those with stage IV (metastatic) breast cancer

[56]. Approximately one-third of women (32%) with breast cancer have an aerobic

fitness level less than the threshold for functional independent living during and up to

approximately three years following completion of treatment [56]. Overall, fatigue,

weight gain and reduced fitness are three common and interrelated adverse effects. For


example, the presence of treatment-related fatigue can lead to increased sedentary

behaviour and contribute to weight gain and deconditioning (i.e. reduced fitness). In

turn, deconditioning can cause patients to become more easily fatigued, with this

ongoing cycle leading to a worsening of adverse effects [62].

1.4.3 Upper body morbidity

Upper body morbidity is also common among women treated for breast cancer.

It is defined as the presence of symptoms and impairments such as pain, weakness,

poor range of motion, numbness, tightness, or swelling in the shoulder, arm, and/or

breast of the affected side [43]. Findings from a review of the literature [43] indicate

that up to 60% of women experience at least one upper body symptom (weakness,

stiffness, numbness, tingling, pain, poor range of motion, swelling) between six

months and three years after surgery. Prospective findings from a representative

sample of women with breast cancer (n=287) have shown that up to 42% of women

experience declines in upper body function between six- and 18-months post-surgery

[63]. Approximately one in five (22%) women experience upper body symptoms

(tingling, weakness, pain, stiffness, range of motion, swelling and numbness) six

months after surgery, with 15 to 25% continuing to experience impaired upper body

function six years post-surgery [49]. Strength is also affected, with 28% of women

experiencing upper body weakness between 6 and 12 months post-surgery [64]; while

24 to 36 months post-surgery, prospective findings report that 40% of women have an

upper body strength impairment of 10% or more (as determined by comparing strength

of the surgical and non-surgical side) [65]. Other common adverse upper body

concerns following breast cancer treatment, identified in prospective studies, include

upper body pain, which is experienced by 51% of patients between one and three years

post-surgery [65], numbness (experienced by 32 to 35%) and tightness (experienced

by 35 to 55%) between 6 and 12 months post-surgery [64]. It is likely that differences

in timing of outcome measures, methods of assessing upper-body morbidity (i.e.

differences in both self-report questionnaires and objective measures), differences in

time since breast cancer diagnosis, treatment characteristics of patients (i.e. post-

treatment versus currently undergoing treatment) and different stages of disease

contribute to differences in reported prevalence rates across the literature. Regardless,

upper body morbidity following breast cancer diagnosis is common and may persist

for years following completion of treatment.


1.4.4 Comorbidities at time of breast cancer diagnosis

The prevalence of comorbidities among women at time of breast cancer

diagnosis is the same as age-matched women with no history of breast cancer [66, 67].

Specifically, no differences in the prevalence of arthritis (29.5% vs. 30.4%),

osteoporosis (6.6% vs. 4.4%), chronic lung disease (11.7% vs. 10.8%), diabetes (8.4%

vs. 7.8%), congestive heart failure or a previous heart attack (4.5% vs. 5.5%) or

hypertension (30.1% vs. 33.8%) were found between a sample of 941 women with

breast cancer (at diagnosis) compared with a representative sample of women without

cancer (n=865) matched for age, race and education [67].

At the time of diagnosis, US population-based data indicates that 67.8% of

women (including pre- and post-menopausal women) have no other comorbidity

present, 22.4% have one comorbidity, and 9.8% have two or more, compared with

68.2%, 20.9% and 10.9% (respectively) among age-matched controls with no history

of cancer [66]. These data are supported by population-based data from the

Surveillance, Epidemiology, and End Results (SEER) US database [26] that indicate

that the prevalence of comorbidities among women with breast cancer is 32% [26],

with the most common comorbidities being diabetes (16%), chronic obstructive

pulmonary disease (16%), congestive heart failure (10%) and cardiovascular disease

(6%) [26].

1.4.5 Comorbidities following breast cancer diagnosis and treatment

Following diagnosis, breast cancer treatments increase the risk of developing

new comorbidities [67, 68]. Between four and nine years after being diagnosed with

breast cancer, survivors experience an average of three newly diagnosed comorbid

conditions [69]. Prospective population-based findings involving 1,183 women with

breast cancer showed that women treated with chemotherapy only (Odds ratio, OR=3.2

[95% CI=1.5, 6.8]), chemotherapy and radiation (OR=1.9 [95% CI=1.02, 3.7]), or

radiation and tamoxifen (OR=1.9 [95% CI=1.1, 3.2]) were significantly more likely to

experience at least one new comorbid condition 24 months post-diagnosis compared

with women who received no adjuvant therapy [67]. Further, prospective findings

from a cohort study involving a sample of breast cancer survivors (n=4,414) indicated

that at a median follow-up of 18 years post-treatment, compared with the general

female population (with no history of breast cancer), breast cancer survivors had a

significantly increased (p<0.05) risk of cardiovascular disease (myocardial infarction:


standardised incidence ratio, SIR=1.23, [95% CI= 1.08, 1.39]; angina pectoris:

SIR=1.30 [95% CI=1.16, 1.45] and congestive heart failure: SIR=1.35 [95% CI=1.22,

1.49]) [70].

Overall, comorbid conditions are common among women with breast cancer.

Due to adverse effects associated with breast cancer therapy and effects secondary to

treatment (e.g. reduced activity and weight gain), women with breast cancer are at an

increased risk of being diagnosed with a subsequent chronic disease compared with

age-matched women without a history of breast cancer [70]. Further, compared with

women with breast cancer who do not receive chemotherapy, radiation or hormone

therapy, women with breast cancer who receive these treatments (either individually,

or in combination) are at higher odds of being newly diagnosed with a comorbidity

post-treatment [67].

1.4.6 Early versus late-stage breast cancer

There are important clinical differences between the different stages of breast

cancer. As described in Section 1.3, higher stages are associated with more invasive

and extensive surgery. More advanced stages of disease are also associated with

greater treatment-related side effects and lower quality of life [71]. Evidence from

prospective studies that have compared women with stage I disease versus stage II to

III disease [71] and stage I to II versus stage III disease [72, 73] indicate that between

two months and seven years post-diagnosis, more advanced stages are associated with

greater upper body morbidity (OR=1.77, [95% CI=1.07, 2.93]) [71] and significantly

worse anxiety, and physical, emotional, functional and overall quality of life (all

p<0.05) [72, 73]. However, a limitation of previous research is the inconsistent

groupings used to compare different stages of breast cancer across studies (e.g. stage

I versus stages II to III; stage I to II versus stage III). Despite this, the findings indicate

that compared with lower stages, more advanced breast cancer is associated with more

extensive treatments, more severe and frequent treatment-related side effects, lower

quality of life and lower survival.

1.4.7 Reduced physical activity participation following breast cancer diagnosis

Evidence from prospective population-based breast cancer cohort studies

demonstrates that, after diagnosis, physical activity levels decline [74-76]. Prospective

population data indicate that between pre-diagnosis and six months post-diagnosis, the


proportion of women who are sufficiently physically active (i.e. engage in at least 150

minutes per week of moderate intensity physical activity) decreases from 60% to 35%,

while the proportion of those who are sedentary increases from 16% to 42% [76]).

Further, findings from a prospective study involving 1,735 women with breast cancer

aged between 20 and 74 years showed that approximately 60% of women reduced their

physical activity levels by greater than 30 minutes per week between pre- and six

months post-diagnosis [76]. Of the remaining sample, approximately 25% of women

did not change their physical activity, while less than one-fifth (15%) increased their

amount of physical activity (by greater than 30 minutes per week) [76]. Findings from

another population-based prospective cohort study (n=1,185) reported that the total

reduction in the amount of physical activity between pre- and 12 months post-

diagnosis is estimated to be 120 minutes per week [75]. This includes participation in

light, moderate, and vigorous intensity physical activity, sports, and household activity

[75].

Understanding physical activity levels at the time of diagnosis and following

diagnosis is important because reduced and insufficient levels of physical activity

among women with breast cancer are associated with more severe and frequent breast

cancer treatment-associated symptoms [49, 77-80]. This includes sleep disturbances,

cognitive issues, reduced fitness and function (particularly of the upper body), anxiety,

depression, fatigue and reduced quality of life [49, 77-80]. Specifically, cross-sectional

findings indicate that three to four months after breast cancer treatment, higher levels

of sedentary behaviour are associated with higher levels of fatigue (β=0.04, p<0.01),

higher levels of pain (β=0.03, p=0.06), and higher levels of depression (β= 0.25,

p<0.01). In contrast, light levels of physical activity were significantly associated with

lower levels of fatigue (β= –0.19, p<0.01) and lower depression (β= –0.15, p=0.05)

[81]. Other cross-sectional findings involving 432 breast cancer patients suggest that

compared to women who were sufficiently active, sedentary women were more likely

to report experiencing weight gain (OR=2.29; 95% CI=1.44, 3.64; p<0.01), shoulder

limitations (OR=1.77; 95% CI=1.14, 2.77; p=0.01), breathlessness (OR= 2.30; 95%

CI=1.35, 3.92; p<0.01), chest pain (OR=1.69; 95 % CI=1.07, 2.65; p=0.023) and arm

lymphedema (OR=1.68; 95% CI=1.04, 2.71; p=0.03) while controlling for age, current

treatment, and surgery type [82].


1.5 BENEFITS OF EXERCISE FOLLOWING BREAST CANCER

DIAGNOSIS

1.5.1 Overview

There is a compelling evidence base demonstrating the benefits of exercise for

women with breast cancer. Exercise trials involving women with breast cancer make

up most of the exercise trials conducted in the cancer survivorship field, with over 80%

of participants in exercise and cancer studies being women with breast cancer [83].

There have been over 140 randomised controlled trials (RCTs) that have demonstrated

the safety, feasibility and effectiveness of exercise for women with breast cancer [83-

86]. Key findings from this work are discussed below.

1.5.2 Effect of exercise on health outcomes and subsequent chronic disease risk

In a meta-analysis of 66 high quality RCTs involving various cancer populations,

but predominantly women with breast cancer (83%), exercise during and following

treatment improved in physical activity levels, aerobic fitness, upper and lower body

strength, body weight, body fat, body mass index (BMI), quality of life, mood, anxiety,

confusion, physical self-perception, self-esteem, fatigue, general symptoms and side

effects and blood biomarkers (all p<0.01, weighted mean effect sizes, WMES range=

0.14 to 0.99) [83]. Findings from another meta-analysis of 56 RCTs specifically

involving women with breast cancer reported significant (p<0.01) benefits for fatigue

(d=0.31), depression (d=0.26), body image (d=0.28) and quality of life (d =0.29) [87].

In terms of longer-term benefits, findings from a longitudinal prospective study of

2,973 women with breast cancer (mean age: 57 years) showed a 23% reduced risk of

cardiovascular events (p<0.01) among breast cancer survivors who adhered to the

National Exercise Guidelines for individuals with cancer, compared with those who

did not follow the Guidelines [88].

1.5.3 Survival benefits of exercise

Survival outcomes in relation to exercise and physical activity have also been

evaluated among women with breast cancer [6, 89-91]. Observational evidence

indicates that increased and higher levels of physical activity post-diagnosis are

associated with improved survival among women with breast cancer [6, 89-91].

Specifically, in a recent meta-analysis of 36 studies (n=68,285 participants with

cancer, 66% with breast cancer), exercise following a cancer diagnosis was associated

with a 28 to 44% reduced risk of cancer mortality, a 21 to 35% lower risk of cancer


recurrence, and a 25 to 48% reduced risk of all-cause mortality [92]. Findings from

another meta-analysis of cohort studies (n=6) specifically involving women with

breast cancer (n=12,108) also demonstrated that post-diagnosis physical activity was

associated with a 41% reduction in all-cause mortality (Hazard ratio, HR=0.59, [95%

CI=0.53, 0.65], p<0.01), 34% less breast cancer deaths (HR=0.66 [95% CI=0.57,

0.77], p<0.01), and a 24% reduction in cancer recurrence (HR=0.76 [95% CI=0.66,

0.87], p<0.01) [90]. This was independent of other prognostic factors including disease

stage and obesity [90].

The potential survival benefits of physical activity highlighted by observational

evidence have recently been supported by findings from two prospective RCTs.

Exploratory follow-up analyses of an RCT (n=242) reported an improved eight-year

disease-free survival in women who performed exercise during chemotherapy

compared to those receiving usual care (82.7% versus 75.6%; HR=0.68; [95%

CI=0.37, 1.24]; log-rank, p=0.21) [93]. More recently, Hayes et al. [94] conducted

exploratory survival analyses of an eight-month RCT evaluating a pragmatic exercise

intervention that commenced six weeks post-surgery involving newly diagnosed

women with breast cancer. After a median follow-up of eight years, 5% versus 12%

of women in the exercise and usual care groups, respectively, had died (overall

survival HR, exercise group=0.45 [95% CI=0.20, 0.96]; p=0.04). Further, disease-free

survival events for the exercise versus usual care group was 12% and 18%,

respectively (HR=0.66 [95% CI=0.38, 1.17]; p=0.16) [94]. Although preliminary, the

findings of survival benefits strengthen a growing evidence base in support of

integrating exercise into breast cancer care. It is this consistent and growing evidence

base that has led to recommendations by international cancer [8] and exercise

organisations [5, 10] that consider exercise as a safe, feasible and effective form of

adjuvant therapy for breast cancer [5, 10].

1.5.4 Limitations of current evidence

Despite a compelling evidence base, exercise is yet to form part of standard

breast cancer care within Australia or internationally. This may be, at least in part, due

to limited existing knowledge. Specifically, the generalisability of findings derived

from the evidence base of exercise trials involving women with breast cancer is unclear

[12]. A systematic review was specifically conducted to determine the generalisability

of safety, feasibility and effect of exercise findings to the wider breast cancer


population [12]). The authors of the review compared the eligibility criteria of previous

breast cancer studies, and compared characteristics of the recruited samples to the

characteristics of a representative population of women with breast cancer [12].

Findings indicated that over two-thirds of studies (77%) restricted eligibility based on

medical conditions, functional status or breast cancer side effects [12]. The mean age

of participants for 60% of included studies was younger than the international average

age of breast cancer diagnosis (less than 56 years, compared with 56 to 62 years,

respectively). Between 30 and 60% of the women were also already physically active

at baseline [12]. Further, almost one-third of the trials (27%) did not report disease

stage of participants, while only one study (1%) specifically recruited women with

stage IV disease [12]. Overall, findings from the review demonstrated that the

eligibility criteria of the majority of breast cancer and exercise studies restricted the

ability to recruit women that are representative of the wider breast cancer population,

and participants in exercise trials tended to be of younger age, with stage I to II disease,

minimal disease burden (i.e. no treatment-related sequelae or comorbidities), and who

have a history of exercise participation [12]. As such, the generalisability of safety,

feasibility and effectiveness findings from exercise trials to older, physically inactive

women with stage II+ disease (who make up 45% of the breast cancer population) is

potentially unclear [2, 12].

1.6 PHYSICAL ACTIVITY AND BREAST CANCER STAGE

As highlighted earlier, the stage of disease at diagnosis influences the treatment

type as well as survival, and the extent and type of treatment is associated with

frequency and severity of treatment-related side effects. The stage of disease also

influences post-diagnosis physical activity levels. More specifically, between pre- and

post-diagnosis, longitudinal evidence indicates that women with later-stage disease are

more likely to reduce their physical activity by greater amounts compared with those

diagnosed with earlier stages [75]. To illustrate this point, evidence from a population-

based, multicentre, multiethnic, prospective cohort study that enrolled 1,185 breast

cancer patients [75] showed that between pre-diagnosis to four to 12 months post-

diagnosis, 52%, 58%, and 62% of patients with stage 0, stage I, and stage II to III

breast cancer, respectively, decreased their total physical activity levels (between

group p<0.05) [75]. Further, those with stage I disease showed average reductions of

3.8% (–0.7 [SD=0.8] hours per week), whereas those with stage II or III disease


reported reductions of 8.9% (–1.7 [SD=0.9] hours per week) [75]. This represents more

than double that of those with localised disease [75].

1.7 SUMMARY

In Australia, breast cancer is the most common cancer among women [1]. There

are significant physical and psychosocial side effects associated with breast cancer and

its treatment (e.g. fatigue and upper body morbidity), which may persist following

completion of treatment. There is compelling evidence that supports exercise as an

important adjuvant therapy for breast cancer. Exercise is considered safe, feasible and

an effective adjuvant therapy, and is recommended during and following breast cancer

treatment [5, 10]. Exercise participation after diagnosis reduces treatment-related side

effects, improve fitness, function and quality of life [3-6]. Preliminary research also

shows that exercise may improve breast cancer survival [6, 89]. Overall, exercise has

the potential to improve patient care, improve physical and psychosocial health and

reduce both the severity and number of side effects associated with treatment [48].

Despite the compelling evidence base, questions regarding the safety, feasibility

and effectiveness of exercise for the wider breast cancer population remain. The

samples of women who have participated in breast cancer and exercise trials to date

are biased towards the more well women with less advanced disease. As such, this

evidence lacks generalisability to women with stage II+ cancer, who make up 45% of

the breast cancer population [1, 11]. There are discrepancies in reporting and grouping

of disease stage in the literature (e.g. stage I and II to IV, or stage I to II and III to IV).

More advanced stages are associated with more intensive treatment, more frequent and

severe treatment-related side effects, greater reductions and lower physical activity

levels and higher morbidity and mortality. All of these factors can potentially influence

the safety, feasibility and effectiveness of exercise.

1.8 THESIS OUTLINE

The broad aim of this PhD was to better understand exercise safety, feasibility,

effectiveness and maintenance among physically inactive women with stage II+

disease. To achieve this, two studies were conducted as part of this PhD research. First,

the safety, feasibility and efficacy of an exercise intervention that was delivered using

a real-world approach was evaluated (Study 1, the SAFE trial, Figure 1.1). Next, the


feasibility and effectiveness of a technology-based intervention to support physical

activity maintenance was evaluated (Study 2, the SAFE-Maintain trial, Figure 1.1).

Figure 1.1 Overview of the Safety and Feasibility of Exercise (SAFE) studies.

Overview of Studies 1 (SAFE, shown in red) and 2 (SAFE-Maintain, shown in blue);

PAC: Physical Activity Counselling group; PAC+F: Physical Activity Counselling

plus Fitbit group.

The details of this PhD research program are divided into chapters, as follows:

Chapter 2 includes a two-part literature review, followed by the study purpose,

methods, results and discussion of Study 1 (the SAFE study). The SAFE study

involved evaluation of a translational exercise intervention for women with stage II+

disease. This study was a 12-week single group pre-post intervention to evaluate an

exercise intervention delivered under the current Medicare funding model of five

supervised exercise sessions.

In Chapter 3, the evaluation of strategies to enable longer-term physical activity

behaviour change are described. This chapter includes a literature review, followed by

the study purpose, methods, results and discussion of Study 2 (the SAFE-Maintain

trial). The SAFE-Maintain was an RCT that evaluated the effectiveness of a physical


activity behavioural counselling session with or without the provision of a consumer

physical activity tracker on exercise maintenance.

In Chapter 4 (Conclusion), the key findings of this PhD research, the significance

of the findings, and how this research contributes to the wider evidence base are

summarised. Finally, how these findings may be used to influence clinical practice and

direct future research is discussed.

1.9 CONTRIBUTION TO THE STUDIES AND THE BROADER

PROGRAM OF RESEARCH WITHIN WHICH THIS WORK SITS

This PhD program involved contributing to the SAFE research project that was

being conducted by the wider research group. The overall SAFE RCT (n=60) involved

two intervention arms: a high supervision arm (n=30) which involved 20 supervised

exercise sessions during a 12-week exercise intervention (not shown in Figure 1.1),

and a low supervision arm (n=30) which involved five supervised exercise sessions

during a 12-week exercise intervention (shown in red in Figure 1.1). The low

supervision arm (n=30) was the focus of Study 1 of this PhD research (shown in red

in Figure 1.1, referred to as SAFE herein). This PhD involved:

1) Implementing 50% of both arms of the overall SAFE RCT (n=60), data

collection and entry, database development and management, data analysis and

write-up.

2) Development of study concept and design of SAFE-Maintain, intervention

implementation, data collection and entry, database development and

management, data analysis and write-up.

Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage

II+ breast cancer (Study 1, the SAFE study) 39

Chapter 2: The safety, feasibility and

effectiveness of a translational

exercise intervention for women

with stage II+ breast cancer

(Study 1, the SAFE study)

2.1 CHAPTER OVERVIEW

This chapter involves a two-part literature review consisting of: 1) a systematic

review and meta-analysis that evaluated the safety, feasibility and effectiveness of

exercise in women with stage II+ breast cancer (Section 2.2); and 2) secondary data

analysis to explore the relationship between number of supervised exercise sessions

and change in health outcomes (Section 2.3–2.4). Findings from the review and

exploratory analysis subsequently informed the design and conduct of the SAFE study

(Study 1). Section 2.5 includes the background, methods, results and discussion of the

SAFE study.

2.2 LITERATURE REVIEW PART ONE: SYSTEMATIC REVIEW AND

META-ANALYSIS

2.2.1 Background

There exists compelling evidence demonstrating the benefits of exercise for

women with breast cancer. However, the generalisability of these findings to women

with stage II+ breast cancer is unclear. As highlighted in the previous chapter, prior

research demonstrating the safety, feasibility and benefits of exercise is derived from

studies primarily involving younger women with early-stage (stage I to IIA) breast

cancer, with minimal disease burden (e.g. no treatment-related side effects or comorbid

conditions), and who are already physically active [12]. As such, it is plausible that

women with stage II+ disease are underrepresented in the body of evidence that

currently supports exercise as being safe, feasible and effective during and following

breast cancer treatment. As a component of this PhD research, a systematic review and

meta-analysis was conducted to evaluate the safety, feasibility and effectiveness of

exercise among women with stage II+ disease. A full version of this systematic review

and meta-analysis is included in Appendix A as a manuscript which has been accepted

40 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with

stage II+ breast cancer (Study 1, the SAFE study)

for publication in Archives of Physical Medicine and Rehabilitation. A summarised

version is included in this chapter.

2.2.2 Purpose

The aim of this systematic review and meta-analysis was to assess the safety,

feasibility and effectiveness of exercise in women with stage II, III or IV disease (i.e.

stage II+). Specifically, this review evaluated: 1) the number, type and severity of

adverse events (safety); 2) study recruitment, withdrawal and adherence rates

(feasibility); and 3) the effect of exercise on health outcomes including quality of life,

aerobic fitness and fatigue. These analyses were performed by evaluating findings

derived from RCTs that involved samples consisting of at least 50% of women with

stage II+ breast cancer.

2.2.3 Methods

Nine electronic databases were searched for articles published prior to 1 March

2017. Randomised, controlled exercise trials involving a sample with at least 50% of

women diagnosed with stage II+ breast cancer were included. Risk of bias was

assessed in each RCT using the Physiotherapy Evidence Database (PEDro) scale [95,

96]. Adverse event severity was classified as grade 1 to 5 using the Common

Terminology Criteria [97] (grade 1: mild symptoms; grade 2: moderate symptoms;

grade 3: severe symptoms, but not immediately life-threatening; grade 4: life-

threatening symptoms; or grade 5: death). Subsequently, the number of adverse events

that occurred in the exercise participants compared with the usual care participants was

pooled and analysed using a Mantel-Haenszel random effects model. The risk

difference (RD) and 95% confidence interval was calculated as the effect measure.

Feasibility was evaluated by computing median (range) recruitment, withdrawal and

adherence rates. Meta-analyses were also performed to evaluate exercise effects on

quality of life, aerobic fitness, fatigue, upper body strength, anxiety, depression, body

mass index, body fat percentage, body mass index and waist circumference. The

effects of exercise mode (aerobic, resistance, combined and other exercise),

intervention supervision (supervised and unsupervised), intervention duration (12

weeks or less and longer than 12 weeks) and intervention timing (during and after

treatment) were also explored.



2.2.4 Results

Following a search of databases and screening of studies, 61 RCTs were included

(low quality, n=24, 39%; high quality, n=37, 61%). Pooled analyses of 60 RCTs (n=1

excluded due to insufficiently reported data) involving 5,200 participants (exercise:

n=2,621; usual care: n=2,579) showed no difference in the risk of a grade 3 to 5 adverse

event between exercise and usual care (exercise: n=54 events, usual care: n=37 events,

RD: 0.00 [91% CI= –0.00, 0.01]; p=0.38; I2=0%). Median (minimum, maximum)

recruitment rate was 56% (1, 96%), withdrawal rate was 10% (0, 41%) and adherence

rate (i.e. session attendance) was 82% (44, 99%). Safety and feasibility outcomes were

similar irrespective of exercise mode, intervention supervision, intervention duration

and intervention timing. Effects of exercise for quality of life, fitness, fatigue, strength,

anxiety, depression, body mass index and waist circumference compared with usual

care were significant (standardised mean difference range, SMD: 0.17 to 0.77,

p<0.05).

2.2.5 Overview of key findings

These findings suggest that exercise is safe, feasible and effective for improving

health outcomes among women with stage II+ breast cancer. Adverse events that were

reported to have occurred as a consequence of exercise during or following treatment

for stage II+ breast cancer were rare, occurring in less than 5% of women. Of the 54

grade 3 to 5 adverse events reported, less than half of these (42%) were exercise-

related, and of these, they were typically mild in nature, representing acute and normal

physiological responses to exercise (e.g. muscle soreness or stiffness).

In terms of feasibility, median recruitment rate was 56%, withdrawal rates were

low (10%) and adherence was high (approximately 80%). Previous systematic reviews

and meta-analyses of exercise trials comprising predominantly of women with early-

stage disease have reported that recruitment rates have ranged between 20 to 70% [86],

withdrawal rates have been low (<10%) and exercise adherence rates have been high

(80–90%) [83, 86, 98, 99]. The findings from this review indicate that exercise during

and following treatment for stage II+ breast cancer is feasible. Findings also indicated

that exercise during and following treatment improved quality of life, fatigue, aerobic

fitness, upper body strength, anxiety, depression, waist circumference and body mass

index (SMD range=0.17–0.77). With the exception of depression and anxiety, these

effects were also similar to those reported in previous meta-analyses involving samples



predominantly consisting of women with early-stage breast cancer [83, 87, 98-105].

Regarding depression and anxiety, greater effects were observed in the present

findings compared with previous findings involving early-stage disease [83, 87, 98-

105]. Further, in the present meta-analysis, subgroup analyses restricted to studies

involving only participants with stage II+ disease showed that the effects of exercise

were greater for quality of life and fatigue, compared with results from analyses

involving all studies. Therefore, there is some evidence to suggest that women with

stage II+ breast cancer experience similar, if not greater, benefits from exercise

compared with women with early-stage disease. However, four key limitations of this

review were identified and are discussed below.

2.2.6 Lack of adverse event reporting

Caution with exercise remains relevant because approximately one-third of

studies (n=21) included in the review made no mention of adverse events (i.e., whether

they occurred or not). Further, most studies (n=49, 80%) did not comprehensively

describe procedures for adverse event monitoring and recording. This lack of reporting

may not indicate the absence of adverse events; instead, exercise-related adverse

events may have been underreported.

2.2.7 Limited representativeness of samples

This review ensured evaluation of women with stage II+ disease (median

proportion of the samples with stage II+ disease across the included studies was 72%;

range: 50–100%); however, sample bias remains plausible. For example, the mean age

of study participants was 53 years, whereas the international median age of a woman

with breast cancer is 62 years [31]. Only one trial specifically evaluated women with

stage IV (metastatic) disease. Further, most trials (79%; n=48) excluded participants

with various comorbidities, yet at least 30% of women with breast cancer experience

at least one comorbidity [49, 66]. Consenting participants were also likely to have a

history of exercise participation, because many of the trials (n=28, 45%) included

participants who were physically active at baseline. In contrast, approximately 60% of

the wider breast cancer population is sedentary or insufficiently active at time of

diagnosis up to six months post-treatment [74-76]. Overall, women involved in the

studies included in this review were likely younger, more healthy, and more physically

active than the wider stage II+ breast cancer population. Further, due to the insufficient

reporting, it was not possible to isolate the different stages and compare effects of



exercise between stages (e.g. stages II, III and IV). Therefore, there may have been

differences in effects between stages which may have been masked by analysing stage

II+ as a subgroup.

2.2.8 Lack of post-intervention follow-up

The median intervention duration across the included studies was 12 weeks, and

less than 10% of trials included post-intervention follow-up to evaluate maintenance

of physical activity and health outcomes. Further, none of the 10 trials that involved

samples consisting solely of women with stage II+ breast cancer involved post-

intervention follow-ups to evaluate maintenance of outcomes. Maintenance of

outcomes is considered important for informing translation of evidence-based health

interventions into practice [106, 107]. The present lack of evidence in relation to

longer-term exercise participation and maintenance among women with stage II+

breast cancer indicates an important area for future research.

2.2.9 Limited ability to translate findings into clinical practice

The extent to which the findings from this review can be translated into clinical

practice in Australia is unclear. Approximately two-thirds (67%, n=41) of the

interventions included in this review were facility-based (i.e. the exercise sessions took

place at a venue such as a research institute or exercise clinic), whereas approximately

half of all interventions (54%, n=33) involved moderate to high levels of supervision

(1 to 3 weekly supervised sessions or telephone-based support for 8 to 52 weeks) from

various professionals, including accredited exercise physiologists (AEPs). These

intervention characteristics do not align with the current reimbursement structure in

Australia. Specifically, under the current Medicare funding structure for chronic

disease (a Chronic Disease Management Plan, CDMP), women with breast cancer are

eligible to receive up to five funded visits with an AEP each year. Although this is

somewhat unique worldwide, this level of supervision and frequency of contact with

a health professional with experience in exercise prescription and behaviour change is

much lower than what has been evaluated in exercise and breast cancer trials to date.

Therefore, the evidence indicating that the real-world approach as being safe, feasible

and effective, particularly for women with stage II+ disease is lacking.



2.2.10 Summary direction for future work

Various limitations of the existing literature are apparent. Notably, it is unknown

if the level of exercise supervision from an AEP that is currently available across the

Australian healthcare system under the Medicare CDMP is in fact safe, feasible and

sufficient to achieve clinically relevant improvements in health outcomes for women

with stage II+ breast cancer. In order to evaluate this specific issue further, Part two of

this literature review involved an exploratory analysis to evaluate the association

between the number of supervised exercise sessions completed and change in health

outcomes among women with breast cancer during participation in a previous exercise

trial. The following section (Section 2.3) includes a discussion of the findings from

this work, and implications of the findings for future research.

2.3 LITERATURE REVIEW PART TWO: EVALUATION OF THE

ASSOCIATION BETWEEN NUMBER OF SUPERVISED EXERCISE

SESSIONS AND CHANGES IN HEALTH OUTCOMES

2.3.1 Background

Under the current Australian Medicare CDMP, individuals with a chronic

medical condition, including breast cancer, are eligible for to up to five funded

supervised exercise sessions with an AEP each year [13]. The intent of a CDMP is to

enable General Practitioners (GPs) to plan and coordinate the health care of those with

chronic or terminal medical conditions, or complex care needs, requiring

multidisciplinary care [13]. The plan was introduced in 1999, known then as an

Enhanced Primary Care Plan. Unfortunately, it is unclear how five visits were

determined as the appropriate number of sessions. Evidence indicating that this

number of visits is effective for producing clinically relevant improvements in physical

activity levels and health outcomes is lacking.

Findings from a previous meta-analysis suggest the amount of exercise

supervision or contact influences the magnitude of benefit [108]. In that review,

interventions involving high levels of supervision (e.g. interventions involving multi-

component, structured sessions, all of which are supervised) had the largest effect on

physical activity participation among women with breast cancer (SMD=0.69 [95% CI=

–0.08, 1.5], p=0.08) [108]. Interventions involving low levels of supervision

(interventions involving little or no individual supervision; e.g. one baseline education

session only) had a smaller effect on physical activity levels (SMD=0.23 [95% CI=



0.09, 0.38], p<0.01)[108]. However, the generalisability of findings to a representative

sample of women with breast cancer is unclear. The mean age of participants in the

meta-analysis [108] was 49 years, all participants had completed treatment (all were

two years or more post-treatment) and most studies (75%) involved only participants

with stage I or II disease and excluded women with stage IV disease.

Overall, it is unclear whether five supervised visits with an allied health

professional prescribing exercise as a form of treatment is sufficient to minimise risk

of exercise-related adverse events (i.e., the safety of this plan is unclear). It is also

unclear whether this level of contact is sufficient for helping individuals to become

and stay regularly active in the short and longer term. As such, exploratory analysis of

an existing database was undertaken to assess the association between the number of

AEP sessions provided to women with breast cancer in an exercise trial, and change

in health outcomes (quality of life, fatigue and aerobic fitness) between baseline (6

weeks post-breast cancer diagnosis) and six months post-surgery [4, 14].

2.3.2 Secondary data analysis

The Exercise for Health trial was Australia’s first exercise effectiveness trial in

the breast cancer setting [4, 14]. The trial evaluated a real-world intervention, whereby

clinical AEPs (who could be reimbursed under the current Medicare system) provided

exercise advice, prescription and support, and used behaviour change strategies to aid

women in becoming and staying sufficiently active during and following their breast

cancer treatment [4, 14]. Participants who were randomised to the exercise

intervention met regularly with an AEP from six weeks after breast cancer surgery and

received up to 14 sessions by six months post-surgery. Frequency of sessions with an

AEP was weekly during the initial weeks of the intervention (which coincided with

their active adjuvant treatment) and then tapered to monthly sessions. The weekly

exercise dose targets were 180 minutes of moderate intensity, mixed-type exercise,

although the more pragmatic goal was to develop independent exercisers capable of

appropriately adapting their exercise to accommodate new or regular barriers (that may

or may not have been related to their breast cancer).

Participating in the Exercise for Health intervention improved breast cancer

survivorship outcomes including fatigue, aerobic fitness, and overall quality of life [4,

14], and was also cost effective [109]. Although adherence to the intervention protocol

was high (i.e. on average, participants completed over 80% of the 14 scheduled AEP



sessions by six months post-diagnosis), due to the pragmatic nature of the trial, some

women received as few as four sessions with their AEP during this same period. As

such, these data provided an opportunity to explore the relationship between change

in health outcomes and number of sessions with an AEP. Outcomes of interest for this

secondary analyses were: quality of life (as measured by the Functional Assessment

of Cancer Therapy-Breast, FACT-B+4, questionnaire; higher scores denote higher

quality of life); fatigue (as measured by the FACIT–Fatigue Subscale; higher scores

denote lower fatigue) [110] and aerobic fitness (as measured by heart rate following

completion of the three-minute step test; lower heart rate indicates higher or improved

fitness) [111]. A non-linear relationship between health outcomes and number of

sessions with an AEP was identified. Subsequent exploratory analyses using

generalised estimating equation modelling showed that improvements in quality of life

and fatigue between 6 weeks and 6 months post-surgery were significant for those who

received >8 sessions (mean improvement [95% CI], quality of life: 5.42 [95%

CI=3.00, 7.85]; fatigue: 2.21 [95% CI=0.48, 3.94]). In contrast, changes in health

outcomes for those who received <8 sessions with an AEP did not reach the clinically

relevant thresholds (quality of life: 3.29 [95% CI= –2.93, 9.53]; fatigue: 0.67 [95%

CI= –3.28, 4.63]). Those who received >8 sessions with an AEP reported smaller

fitness declines during the treatment period compared with those who received <8

sessions, although findings were not supported statistically. A full description of the

statistical analyses and results tables from these exploratory analyses are included in

Appendix B. The commentary on these results, published as an article in Exercise and

Sports Science Australia’s MOVE magazine, can also be found in Appendix C.

2.3.3 Limitations and potential implications of these findings

These results reflect associations and do not infer causality. Participants who

received <8 sessions may have experienced greater barriers to exercise participation

and may have been less healthy compared with the women who received >8 sessions.

For example, trends indicated that compared with women who received >8 sessions,

women who received <8 sessions were more likely to be overweight or obese (67%

vs. 51%), receive chemotherapy (80% vs. 61%) or radiotherapy (55% vs. 45%) and

have lower quality of life at baseline (116.90 [95% CI=113.82, 119.97] vs. 113.60

[95% CI=107.78, 119.42], respectively (see Appendix B). However, if the data are

biased in this manner, then this would highlight the need for greater advice,



prescription and support from an AEP in achieving improved health outcomes through

exercise. Moreover, as noted above, only a total of five sessions are available under

Medicare. Only a small number of participants in the Exercise for Health trial [4, 14]

received five sessions (n=4 participants), and therefore it was not possible to compare

groups based on <5 sessions versus >6 sessions. Nonetheless, these findings suggest

that the current health model which supports only five sessions per year with an AEP

may not be sufficient for most women with breast cancer to achieve improvements in

health outcomes through exercise and this requires evaluation.

2.4 DIRECTION FOR FUTURE STUDY

Findings from this two-part literature review have identified several key areas

for future research (as discussed in Sections 2.2.6 to 2.2.9). In summary, these are:

1. A sample bias likely exists within current exercise and breast cancer studies

whereby consenting women are plausibly younger, have less disease burden, and

are more likely to be physically active compared with non-consenting or ineligible

women. The safety, feasibility and effectiveness of exercise in a more

representative sample of women with stage II+ breast cancer (i.e. aged 56 or over,

diagnosed with at least one comorbidity, and who are physically inactive) remains

unclear.

2. The translational capacity of exercise interventions evaluated to date is limited.

The safety, feasibility and changes in health outcomes associated with

participation in an exercise intervention that is aligned with the current funding

model for chronic disease (i.e. up to five sessions with an AEP) lacks an evidence

base and requires investigation specifically among physically inactive women

with stage II+ breast cancer.

3. Adverse events are rarely monitored or reported comprehensively in breast cancer

and exercise trials. Evaluation of exercise safety is required. This is particularly

important for those with stage II+ disease due to their high disease burden.

The aim of this research was to address these knowledge gaps. The research

objective was to evaluate the safety, feasibility and effect of an exercise intervention

that is delivered under the current Medicare rebate scheme for a CDMP (i.e. five

supervised exercise sessions) among a sample of women with stage II+ breast cancer.



The background, methods, results and discussion for the SAFE study are presented in

the remaining sections of this chapter.

2.5 THE SAFE STUDY (STUDY 1)

2.5.1 Aim

The aim of this study was to evaluate the safety, feasibility and effect of a 12-

week exercise intervention delivered by a pragmatic supervision model in women who

were (1) undergoing, or have completed within the previous five years, adjuvant

treatment for a primary, invasive, stage II+ breast cancer, (2) who were considered to

have a high disease burden (i.e. presence of at least one treatment-related sequelae or

comorbidity) and (3) were physically inactive (i.e. not meeting the Australian physical

activity guidelines of 150 minutes of weekly physical activity). The study used a

single-group pre-post design to evaluate a 12-week exercise intervention, delivered

through five sessions with an AEP over this period (i.e. in line with the current CDMP

funding model for receipt of AEP services).

2.5.2 Hypotheses

It was hypothesised that participating in a 12-week exercise intervention

delivered by a pragmatic supervision model is safe (evaluated by adverse events

resulting from exercise) and feasible (evaluated by retention, compliance and

adherence) for a representative sample of women with stage II+ breast cancer.

Hypothesis statements (Safety):

• Null hypothesis (H0): There would be >1 serious exercise-related adverse

event that result in exercise cessation for two or more weeks.

• Alternative hypothesis (H1): There would be no exercise-related adverse

events that result in exercise cessation for two or more weeks.

Hypothesis statements (Feasibility):

• Null hypothesis (H0): Participant retention, adherence and compliance

would be <75%.

• Alternative hypothesis (H1): Participant retention, adherence and

compliance would be >75%.



Secondary objectives: To evaluate intervention effects on aerobic fitness, upper

and lower body strength, balance, body weight, body composition, overall quality of

life, physical functioning, anxiety, depression, fatigue, sleep, pain, social wellbeing,

exercise self-efficacy, and physical activity levels.

Hypothesis statements:

• Null hypothesis (H0): There would be no change in aerobic fitness, upper

and lower body strength, balance, body weight, body composition, overall

quality of life, physical functioning, anxiety, depression, fatigue, sleep, pain,

social wellbeing, exercise self-efficacy, and physical activity levels between

pre- and post-intervention.

• Alternative hypothesis (H1): There would be clinically meaningful

improvements observed in aerobic fitness, upper and lower body strength,

balance, body weight, body composition, overall quality of life, physical

functioning, anxiety, depression, fatigue, sleep, pain, social wellbeing,

exercise self-efficacy, and physical activity levels between pre- and post-

intervention.

2.5.3 Ethical approval and informed consent

Prior to commencing enrolment and data collection, ethical approval for this trial

was sought and obtained from the Human Research Ethics Committee at the

Queensland University of Technology (Approval #: 1400000976) and participating

hospitals where recruitment took place (Mater Hospital Ref. No: HREC/14/MHS/155;

Holy Spirit Hospital Ref. No: HREC 15/19). All participants provided written

informed consent prior to beginning participation in the trial.

2.5.4 Methods

2.5.4.1 Eligibility criteria

To be eligible, participants needed to be aged 18 years or older (i.e. adults who

were able to provide informed consent); reside or work in greater Brisbane (i.e. living

within a 60 kilometre radius of the central business district); and be diagnosed with

stage II+ breast cancer. The residence criterion allowed for the AEP (the PhD

candidate) to travel to participants’ homes for exercise intervention sessions. All

participants needed to either be currently undergoing or have completed treatment

within the previous five years. Additionally, participants were assessed on a range of



factors to determine their disease burden (Table 2.1); eligible participants needed to

be insufficiently physical active (i.e. engage in less than 150 minutes of moderate

intensity physical activity per week). They also needed to meet one or more of the

following criteria: a confirmed clinical diagnosis of at least one comorbidity or chronic

disease (e.g. hypertension, overweight or obesity [body mass index > 25 kg/m2],

osteoporosis or type II diabetes), or at least one chronic breast cancer treatment

sequelae (e.g. lymphoedema, peripheral neuropathy, fatigue or arthralgia). In the

absence of a clinical diagnosis, participants with self-reported treatment-related

sequelae rated as moderate or severe in intensity (defined as: moderate = noticeable

often, with some impact on daily activities; severe = noticeable most of the time and

impacts on daily activities) were considered eligible since treatment-related sequelae

are not routinely screened, detected and recorded by follow-up care.

Table 2.1

Summary of eligibility criteria

A woman was eligible if she displayed:

All of the following: Plus, one or more of the following:

• undergoing treatment for stage II+

breast cancer; OR completed

treatment for stage II+ breast cancer

within < 5 years.

• not meeting national physical

activity level recommendations (i.e.

engages in <150 minutes per week

physical activity).

• comorbidities or chronic disease

including hypertension, hyper-

cholesterolemia, overweight or

obesity, osteopenic or has

osteoporosis, type II diabetes.

• chronic breast cancer treatment

sequelae such as lymphoedema,

neuropathy, fatigue, or arthralgia.

Exclusion criteria included being sufficiently physically active (i.e. currently

meeting national physical activity recommendations of at least 150 minutes per week

of physical activity [112]); breast cancer diagnosis of less than stage II; planning to

become pregnant during the study; planning to be away during the study period (e.g.

holidays); plans for additional surgery during the study period (e.g. reconstructive); or

unable to provide informed consent.

These eligibility criteria ensured the subgroup of the breast cancer population

that has been underrepresented in previous exercise studies [12] was specifically

targeted for participation in this study.



2.5.4.2 Recruitment

Potential participants were recruited using two approaches:

1. A multi-phase process was used to recruit potentially eligible women from two

participating private hospital (Mater Private Hospital Breast Cancer Centre and

Holy Spirit Northside Private Hospital) and one public Brisbane-based hospital

(Mater Public Hospital).

a. First, breast care nurses and oncologists informed potentially eligible women

about the study during routine follow-up appointments and provided them

with study information packages. Study information packages included a

letter outlining the study, an expression of interest form, consent form, refusal

of consent and a reply-paid envelope that could be returned to the

investigator. These packages were distributed at the participating hospitals.

The study packages were signed by the woman’s oncologist or surgeon,

which provided consent for the researcher to contact them.

b. Second, breast care nurses reviewed medical records of women who

completed adjuvant treatment (excluding hormone therapy) at the site and

were diagnosed up to 12 to 24 months prior (i.e. individuals who were no

longer visiting the hospital for regular follow-up care). Potentially eligible

individuals were mailed a study information package (as described above). If

a consent, or decline to participate form was not received within one month

following the mail-out to these participants, these individuals were telephone

called, the study was explained, and interest in participating was determined.

c. Additionally, recruitment fliers with a study overview, summary of eligibility

criteria and researcher contact details were displayed in the waiting rooms of

the breast cancer departments of the participating hospitals.

Breast care nurses and clinicians actively collaborated in the project to meet

recruitment targets and ensure the target sample was recruited.



4. The trial was also advertised through various media and social announcements

including through the Institute of Health and Biomedical Innovation (Queensland

University of Technology, Brisbane) social media pages (e.g. Facebook).

Researcher contact details (telephone number and email address) were included

in the advertisement. The study was also advertised using local media and relevant

newsletters (including the Quest Community newspaper, which is a free

community print- and online-based newspaper distributed across Brisbane).

Upon expression of interest (if either a consent to participate in the study form

was received or the participant contacted the researcher), potentially eligible women

were contacted by telephone. Participants who contacted the researcher but did not

receive a study information package were then either mailed a study information

package (as described above) or had the study information explained to them over the

telephone. This included the study purpose, procedures, participant requirements, and

duration. Potential participants were given an opportunity to ask questions about the

study, and were informed of their right to withdraw from the study at any time. At that

stage, interest in participation was established and eligibility criteria screening was

administered over the telephone. During telephone eligibility screening, information

on cancer history, current and previous cancer treatments, treatment-related side

effects, lifestyle (including current physical activity level, as minutes per week),

medical history (including medications), personal details, general practitioner details

and emergency contact details were obtained (see Appendix D for a copy of the

telephone screening form). If eligible, informed consent was obtained, a baseline data

collection assessment was scheduled, and, following the data collection, the

intervention commenced. If a completed consent form was not sent to the researcher,

participants were asked to bring the completed consent form with them to their first

scheduled baseline data collection assessment. Consent was also obtained from

participants for research staff to contact participant’s treating physician (for

participants undergoing current treatment) or GP (for participants no longer under the

regular treatment of an oncologist) to confirm medical approval for participating in the

study, prior to scheduling of baseline data collection assessment.

Baseline characteristics data included clinical information (breast cancer

specific, including disease stage, number of lymph nodes removed, type of surgical

and adjuvant treatment undertaken and adverse events during the treatment period),



full health history and demographic information (including age, education, income,

marital status, area of residency, number and ages of children). These details were

acquired through self-report.

Baseline and post-intervention (12-week) data collection assessments were

conducted at Queensland University of Technology, Brisbane, Australia, at the

Institute of Health and Biomedical Innovation exercise testing facilities. Supervised

exercise sessions were conducted at a participant’s home or other location convenient

for each participant (e.g. local gym or park).

2.5.4.3 Blinding

Due to the nature of the intervention, participant blinding to the intervention was

not possible. Additionally, all baseline and post-intervention assessments were

completed by the PhD candidate.

2.5.4.4 Intervention

All participants received an individualised, progressive 12-week home-based

exercise program. The target weekly exercise dose was 150 minutes of moderate

intensity, combining resistance and aerobic exercise [5, 113]. Exercise intensity was

prescribed using the Borg Rating of Perceived Exertion (RPE, 6-20 scale, [114]), with

an RPE of between 12 and 14 considered as moderate intensity. The exercise

prescription considered participant characteristics, exercise tolerance/capacity,

treatments, and the presence of treatment-related symptoms to meet the intervention

target. That is, although each participant’s exercise program was individualised, the

total exercise dose prescribed was at least 150 minutes of moderate intensity exercise

each week. For example, participant #1 may have accumulated the required exercise

dose by walking three days per week for 30 minutes and undertaking resistance-based

exercise for 30 minutes on an additional 2 days per week. Participant #2 may have

exercised (including walking, stationary cycling and resistance-based exercise using

hand weights) twice daily for 10 to 15 minutes. This exercise prescription has been

used in previous breast cancer and exercise trials [4, 14]. A real-world, pragmatic

approach to the delivery of this intervention was used in SAFE, with participants

receiving five face-to-face supervised exercise sessions during the 12-week

intervention period. Most (>95%) of the exercise sessions undertaken by the



participants during the 12-week intervention period were unsupervised. An example

of implementation of the exercise sessions is shown in Table 2.2.

Table 2.2

Example of supervised intervention delivery and integration of five supervised

sessions

Week Sessions

1 1 session/week supervised (1 of 5), 2 sessions/week unsupervised.


3 to 4 3 sessions/week unsupervised.


6-7 3 sessions/week unsupervised.


9 to 11 3 to 4 sessions/week unsupervised.

12 1 session/week supervised (5 of 5), 2 to 3 sessions/week

unsupervised.

Participants were recommended to complete at least three aerobic-based exercise

sessions and two resistance-based exercise sessions per week [5, 10]; however, this

was prescribed on an individual basis. Therefore, if this was not feasible, or preferred

for an individual, then the recommendation was modified. Although walking was the

primary mode of aerobic exercise prescribed to participants, other modes of aerobic

exercise (e.g. stationary cycling) were prescribed according to participant preferences,

safety considerations, exercise capacity and access to appropriate exercise equipment.

Resistance exercises were performed using body weight, resistance bands, free-

weights (e.g. hand-held dumbbells), or machines, with the prescription for each

exercise typically being 1 to 3 sets of 8 to 12 repetitions. Participants were provided

with a resistance band and hand-held dumbbells for use during the study period to

facilitate home-based exercise if required. Progression of exercise during the 12-week

intervention was also individualised and monitored by the AEP during supervised

sessions. Progression was achieved by: (1) increasing exercise frequency (e.g.

performing an additional session each week); (2) increasing exercise intensity (e.g.



increasing RPE by walking at a faster pace, walking up hills, lifting a greater weight

or performing more repetitions); (3) increasing exercise duration (e.g. walking 10

minutes longer within a given session); and/or (4) incorporating new exercise types.

An example of an individualised prescription for incorporating both aerobic- and

resistance-based exercise is shown in Table 2.3, and an example of an individualised

exercise prescription for accumulating at least 150 minutes per week during supervised

and unsupervised sessions is shown in Table 2.4.

Table 2.3

Examples of scheduling of sessions of resistance and aerobic exercise during the 12-

week intervention

Resistance exercise Aerobic exercise

Weeks 1-4 3 sessions per week

30-minute sessions

12 to 13 RPE

3 sessions per week

20-minute sessions

12 to 13 RPE

Weeks 5-12 3 to 4 sessions per week

30 to 45-minute sessions

13 to 14 RPE

4 to 5 sessions per week

20 to 30-minute sessions

13 to 14 RPE

RPE: Rating of perceived exertion.



Table 2.4

An example of an individualised exercise prescription with target weekly dose of 150

weekly minutes of moderate+ intensity exercise during the 12-week intervention

Supervised session

Time (example)

Unsupervised

session times

(examples)

Total weekly

activity

Weeks 1-4 60 minutes total

(1 × 60-minute

session/week)

90 minutes total

(1 × 45-minute

resistance-based

exercise session + 3×

15-minute aerobic-

based exercise

sessions)

150 minutes

Weeks 5-12 60 minutes total

(1 × 60-minute

session/week)

90 minutes total

(1 × 45-minute

resistance-based

exercise session + 3×

20-minute aerobic-

based exercise

sessions)

>150 minutes

2.5.4.5 Delivery and location of supervised sessions

The five supervised sessions were in-person sessions conducted at a participant’s

home (or their usual exercise location, e.g. a local gym or park).

2.5.4.6 Scheduling of supervised sessions

Scheduling of supervised sessions was prearranged with participants on an

individual and session-by-session basis. To reflect standard exercise delivery in

clinical settings, the first supervised session was in week one of the intervention

(session one of five). This was to ensure that all participants were educated with respect

to how to exercise safely and how to begin the exercise program with an adequate

understanding of the exercise program and requirements (e.g. reasons for ceasing

exercise, safe technique of resistance exercises, and appropriate intensity of exercise).

Following the first supervised session, the AEP used clinical reasoning to determine

when it was appropriate and ideal for a participant to receive the remaining four

supervised sessions over the subsequent 12 weeks [115]. This means that, for example,

after session one (week one), participant #1 may have received a supervised session

approximately once per fortnight over the 12 weeks, whereas participant #2 may have



received four supervised sessions in the first five weeks of their program and one

supervised session between weeks six to 12.

2.5.4.7 Role of the AEP during the supervised sessions

The role of the AEP during the supervised sessions was to adhere to ESSA’s

Scope of Practice for AEPs [115], while also adhering to study protocol which

included: exercise prescription and supervision (including ensuring correct exercise

technique, monitoring exercise intensity, discussing progress, and adjusting the

exercise program as necessary), exercise counselling (including behavior change and

support on overcoming barriers to participation), health promotion, and motivation to

continue exercise participation [115, 116]. During all supervised sessions, the AEP

used a patient-centered approach by following the Chronic Disease Self-Management

Intervention Model (CDSM) [117]. The Social Cognitive Theory (SCT) [118] and the

Social-Ecological Model [119] form the underlying theoretical framework of this

model. This is a patient-centred model that implements a structure of ‘Assess, Advise

and Assist’ and emphasises collaborative discussions, with the AEP offering support

and guidance in maintaining physical activity, while acknowledging each participant’s

individual circumstances in the context of their life and incorporating this into the

exercise prescription [117].

2.5.4.8 Structure and content of supervised session 1

A summary of the general structure of supervised session 1 is shown in Table

2.5. An overview of the education content covered by the AEP during the first session

is show in Table 2.6 (a more detailed overview is included in the Case Management

Folder (CMF) Appendix E).

Table 2.5

Summary of the structure of supervised session 1

Assess: 1. Complete medical history questionnaire.

2. Develop understanding of previous exercise habits.

3. Identify/discuss possible barriers to exercise.

Advise: 4. Prescribe exercise for coming week(s) and complete

logbook.

Assist: 5. Record any strategies discussed about overcoming

barriers or dealing with adverse events.



Table 2.6

Education content covered during supervised session 1

What to expect

1. Overview of the program, scheduling requirements and exercise

prescription goals (150 minutes of exercise per week at RPE 12-

14).

2. Explain how these goals can be individualised and modified.

3. Explain that your role is to help them to reach this goal, but if

they are unable to reach the goal, you will need to explain what

can be done in the future to help them further.

Potential

benefits

4. Physical benefits.

5. Emotional/psychosocial benefits.

6. Improvements in quality of life.

7. Short-, medium- and long-term benefits.

Exercise safety

8. Emphasise that maintaining safety is the most important aspect of

this study.

9. Explain adverse events: an injury or exacerbation of your

symptoms that you think was caused by your exercise.

10. Ask them to contact you as soon as possible in the event of an

adverse event no matter how minor.

Free to

withdraw

11. They are free to withdraw at any time by any means, without

judgement or penalty.

12. They may withdraw from the intervention only, or from the

intervention and data collection sessions.

Discuss side

effects

13. How being physically active can reduce the severity of side

effects.

14. Too much exercise can exacerbate side effects.

15. You will be checking in on these side effects to monitor any

changes and adjust exercise prescription accordingly.

When not to

exercise

16. Discussion of exercise safety and when not to exercise.

When to cease

exercise

(immediately

and call GP /

ambulance)

17. Chest pain, pressure or heaviness, or tingling in the arms.

18. Unsteady, rapid or fluttery heartbeat.

19. Any other unusual feeling such as dizziness, faintness or pain.

Prescribing

exercise

20. Explain fatigue and muscle soreness.

GP: General Practitioner.

RPE: Rating of perceived exertion.



2.5.4.9 Structure and content of supervised sessions 2 to 5

A summary of the structure of sessions 2 to 5 and the education content covered

by the AEP during the intervention is shown in Tables 2.7 and 2.8 respectively (a more

detailed overview is shown in the CMF in Appendix E). The education topics covered

by the AEP during the five supervised sessions (Table 2.8) were covered during each

session on an individualised basis. Depending on the individual and stage of

intervention, three to five topics were covered in each session to ensure that all topics

were covered during the 12 weeks.

Table 2.7

Summary of the structure of supervised sessions 2 to 5

Assess: 1. Review exercise tracker and compare exercise

prescription to exercise undertaken.

2. Barriers to exercise.

3. Changes to medication and treatments.

4. Changes to treatment-related side effects.

5. Adverse events (documentation of adverse events if

necessary).

Advise: 6. Prescribe exercise for coming week and complete

exercise tracker (include name of resistance/mobility

exercises prescribed).

Assist: 7. Record any strategies discussed about overcoming

barriers or dealing with adverse events.



Table 2.8

Overview of the education content covered by the AEP during the 12-week

intervention

Topic

1. What to expect during the intervention.

2. Exercise and breast cancer treatment side effects.

3. Why exercise is important (i.e. benefits and importance of exercise).

4. When not to exercise.

5. Exercise safety.

6. What and how much exercise to do (exercise intensity and amount).

7. Starting and progressing.

8. Exercise frequency.

9. Exercise duration.

10. Exercise type.

11. Exercise intensity.

12. Exercise session components (e.g. warm-up, exercise, cool-down).

13. Goal-setting.

14. Motivation and support.

15. Identify and problem-solving barriers.

16. Getting back on track (i.e. returning to exercise after a set-back).

17. Exercise after the intervention (i.e. long-term exercise).

During each session, the AEP focused on building exercise self-efficacy and

verbal praise was used when participants completed prescribed unsupervised exercise,

and they were given positive encouragement and advice when unsuccessful in meeting

any weekly targets. While 100% weekly compliance to the individualised prescription

was emphasised, individuals were also reminded that the long-term goal was to

progress to, and then maintain, 150 minutes of moderate intensity exercise each week.

It was acknowledged that doing more exercise is better than less (up to their weekly

target) but that this may not be attainable every week for a variety of reasons. Exercise

achievements (i.e. meeting of weekly goals) were acknowledged, personal barriers to

exercise were identified, and strategies to overcome them were discussed. Thereafter,

subsequent exercise goals were established, unsupervised exercise was prescribed, and

ongoing self-monitoring of exercise was encouraged by the AEP.

2.5.4.10 Exercise logbooks

Participants received a study-specific exercise logbook to record details about

exercise type, duration, frequency and intensity, exercises prescribed and undertaken,

as well as to document occurrence of adverse events and barriers to exercise (Appendix



F). During each supervised session, the AEP used the logbook to prescribe exercise

for the participant to complete until the next scheduled visit. Participants were also

asked to record any other relevant information such as modifications to the prescribed

exercise dose (e.g. intensity or duration). During supervised sessions, the logbook was

reviewed by the AEP to assess adherence and address any concerns or queries that

arose.

2.5.4.11 Data collection

Timing of assessments (self-reported and objectively-assessed) were pre-

intervention (baseline) and immediately post-intervention (12 weeks). Standard

instructions given to participants in preparation for data collection were to not

participate in strenuous exercise in the 24 hours preceding exercise testing and avoid

excess caffeine ingestion (i.e., in excess of their usual amount) on the day of testing.

All participants were asked to empty their bladder immediately prior to BIS

measurements. Timing of assessments were not standardised and were dictated by

patient preference and availability. A copy of the data collection sheet that guided the

collection of objectively-evaluated outcomes by the AEP during exercise testing visits

and self-reported questionnaire is included in Appendix G.

2.5.4.12 Outcomes of interest

Intervention safety: Adverse events

Adverse events were defined in accordance with the Good Clinical Practice

Guidelines [120] as ‘any unfavorable and unintended sign, symptom or disease that

occurs in a participant whether it is considered to be study- or non-study-related’ and

a serious adverse event was defined as an ‘untoward medical occurrence that requires

hospitalisation, results in permanent or significant disability, is life-threatening and/or

results in death’. Examples of adverse events included (but were not limited to): falls,

sprains, fractures, injuries, episodes of low blood sugar, strains, pulls, tears of muscle

or bone or any other undesirable health or medical event. Exercise-related adverse

events were events that occurred during or within two hours of completing exercise,

or as a direct result of exercise as considered by the participant or AEP. These adverse

events were self-reported by participants to the AEP during supervised exercise

sessions, or when deemed ‘serious’ (defined above). Participants were instructed to

report them over the telephone immediately, or as soon as possible following the



adverse event. Adverse events were categorised according to the Common

Terminology Criteria for Adverse Events, Version 4 [97] as grade 1: asymptomatic or

mild symptoms, clinical or diagnostic observations only and/or intervention not

indicated; grade 2: moderate, minimal, local or non-invasive intervention required

and/or limiting age-appropriate activities of daily living; grade 3: severe or medically

significant but not immediately life-threatening, hospitalisation and/or prolongation of

hospitalisation indicated, disabling and limiting self-care activities of daily living;

grade 4: life-threatening consequences and urgent intervention indicated; or grade 5:

death. Adverse events that required hospitalisation, resulted in significant disability,

were life-threatening or resulted in death were to be reported to the University Human

Research Ethics Committee as soon as possible [120].

Intervention feasibility

Intervention feasibility was assessed by computing retention, adherence, and

compliance rates. The exercise intervention was deemed as ‘feasible’ if retention,

adherence and compliance had a pre-defined acceptability rate of 75% or higher [121,

122]:

1. Participant retention: (#completed follow-up testing ÷ #completed baseline

testing) × 100%.

2. Adherence (at least one of the following adherence criterion must be met):

a. Mean adherence to supervised exercise sessions: (#supervised exercise

sessions completed ÷ 5 scheduled supervised exercise sessions) ×

100%, calculated per participant.

b. Mean adherence to prescribed exercise sessions, including

unsupervised and supervised sessions: (#completed sessions ÷

#prescribed exercise sessions) × 100%, calculated per participant.

3. Compliance (at least two of the following compliance criterion must be met):

a. Compliance to weekly intervention target = (average minutes of moderate

intensity physical activity performed per week ÷ minutes of moderate

intensity physical activity prescribed per week [i.e. 150 minutes per week]).

This was subjectively reported using logbooks. The intervention was

considered feasible if average weekly minutes of exercise was at least 113

minutes per week (i.e., >75% of the 150 minutes per week).



b. Proportion (n, %) of participants performing on average 150 minutes or more

each week of moderate intensity weekly exercise. The intervention was

considered feasible if >75% of participants averaged 150 minutes or more

each week of moderate intensity exercise.

c. Proportion (%) who met the weekly intervention target >75% of the time (i.e.

at least nine of the 12 weeks). The intervention was considered feasible if

>75% met the weekly intervention target for at least nine of the 12 weeks.

d. Proportion (%) of participants that averaged >75% of the intervention target

of 150 minutes per week during the intervention (i.e. 113 minutes per week).

The intervention was considered feasible if >75% averaged at least 113

minutes per week of moderate intensity exercise.

2.5.4.13 Secondary outcomes

All secondary outcomes were assessed at baseline and 12-week post-

intervention. A summary of all secondary outcomes is shown in Table 2.9.



Table 2.9

Overview of all secondary outcomes

Outcome Test or instrument used

Objectively-measured:

1. Aerobic fitness 6-minute walk test (total distance walked, metres)

[123-126]

2. Upper-body strength YMCA bench press test (total no. of repetitions)

[127, 128]

3. Lower-body strength 30 second sit-to-stand test (total no. of repetitions)

[129-131]

4. Balance Single leg stance test (total duration, seconds) [132,

133]

5. Body weight Scales (weight in kilograms) [127]

6. Body mass index Height and weight (kg/m2) [127]

7. Body composition Bioimpedance spectroscopy (% body fat) [127, 134,

135]

Participant-reported:

8. Quality of life FACT-G [136, 137]

PROMIS Global Health Scale Short-form [138-140]

Physical health

Mental health

PROMIS-43 Profile [141]

Physical function

Anxiety

Depression

Fatigue

Sleep

Satisfaction with social roles

Pain interference

9. Upper-extremity

function

PROMIS Upper-extremity Scale [142]

10. Exercise self-efficacy Barrier self-efficacy scale [143-145]

11. Physical activity The Active Australia Survey [146-150]

FACT-G: Functional Assessment of Cancer Therapy - General

PROMIS: Patient-Reported Outcomes Measurement Information System.

Aerobic fitness

The 6-minute walk test was used to evaluate aerobic fitness, following the

protocol of the American Thoracic Society [123], which is consistent with previous

breast cancer trials [124]. The test is a submaximal test that measures functional

exercise capacity and is reflective of activities of daily living. The test has strong test-

retest reliability, an intra-class correlation of 0.97 [125] and is sensitive to change

following a rehabilitation program [126]. The test was completed indoors along a 30-

metre length track, with participants walking the length of the track and back to the



starting point (i.e. 60 metres per lap). Upon completion of the test, the total distance

walked was recorded and reported in metres.

Upper body strength

Upper body strength was measured using the YMCA bench press [127]. The

YMCA bench press is a standard test for objectively measuring upper body strength

and endurance, is considered safe with appropriate supervision, and is a valid test for

upper body strength assessment [151]. Following a standardised protocol [128],

participants lifted a 10-kilogram barbell for as many repetitions as possible, in rhythm

with a metronome set to 15 repetitions per minute.

Lower body strength

Lower body strength was measured using the 30-second sit-to-stand test [129].

The test measures how many times an individual can stand up and sit down from a

chair in 30 seconds [130] and has been used previously to evaluate lower body strength

among women with breast cancer [129]. The number of times the participant stood up

in the 30 seconds was counted and reported. Test-retest intra-class correlation (ICC)

for this test is 0.92 for women and the test is moderately-to-highly correlated with

maximum leg strength assessed with weight-adjusted leg press among women (r =

0.78), providing support for the criterion-related validity of this test as a measure of

lower body strength [130, 131].

Balance

Balance was measured using the single-leg stance test following previous

protocols [132]. The test has an ICC of 0.83 [133] and involves participants standing

unsupported on one leg (participant’s preferred leg), with eyes closed for as long as

possible. The maintenance of balance duration was recorded in seconds, with a longer

duration indicating greater balance.

Body weight and body mass index (BMI)

Participant’s body weight (kilograms) and height (centimetres) were measured

using calibrated scales and a stadiometer (with shoes removed) [127]. Body mass

index (BMI) was calculated as kg/m2 [127].

Body composition

Body composition was assessed using bioimpedance spectroscopy (BIS,

ImpediMed IMPTM DF50; ImpediMed, Brisbane) using previously defined protocols



[134, 135]. This method calculates total body water, fat-mass and fat-free mass by

passing an electric current through the body fluids. The manufacturer’s software was

used to obtain body composition measures (i.e. % body fat). Participants were assessed

in a supine position with a towel between their legs to prevent skin contact. Electrodes

were then placed on the participant’s wrists and feet, as per the manufacturer’s

instructions for assessment of body composition [134, 135].

Patient-reported outcomes

Quality of life

Three different instruments were used to evaluate quality of life and related

outcomes (FACT-G, PROMIS Global Health Scale, Short-form and PROMIS-43

Profile Version 2.0).

• FACT-G: The FACT-G is a validated instrument designed specifically to

assess health-related quality of life among breast cancer patients. The

questionnaire assesses four wellbeing domains (subscales): physical

wellbeing, social/family wellbeing, emotional wellbeing and functional

wellbeing [136, 137]. The questionnaire is sensitive to change in cancer

patients, has a high test-retest reliability (coefficient=0.97) [152], good

internal consistency (Cronbach alpha=0.9), is sensitive to change (t=−3.53;

p<0.01) and is able to differentiate according to extent of disease (p<0.01)

[153]. An overall quality of life level is yielded (overall FACT-G total score,

ranging from 0 to 108), in addition to individual subscale scores for

physical, social, emotional and functional wellbeing, with higher scores

indicating higher quality of life.

• PROMIS Global-10 Health Scale, Short-form: The PROMIS Global-10 is a

brief measure of health status [138, 139]. The questionnaire is not cancer-,

or disease-specific; however, it has previously been used to evaluate quality

of life among cancer patients [154]. The questionnaire consists of 10 items

and has shown to have high internal consistency (Cronbach’s α =0.92 to

0.96) [140]. Each item includes Likert scale response options, except pain

which is measured by an 11-point numeric rating scale. Items are scored on

a 1 to 5 scale, with higher scores indicating better health (e.g. better

functioning or less severe symptoms).



• PROMIS-43 Profile (version 2.0): The PROMIS-43 Profile is a patient-

reported measure of symptoms, functioning, and health-related quality of

life in chronic disease [155] and has shown to have good reliability (α ≥

0.92) [141]. The questionnaire consists of seven domains (physical

functioning, depression, anxiety, pain intensity, fatigue, satisfaction with

social roles and sleep), with each domain consisting of six items. Items are

scored on a 1 to 5 scale, with higher scores indicating better health (e.g.

better functioning or less severe symptoms).

Upper-extremity function

Self-report upper extremity function was assessed using the PROMIS Upper

Extremity Scale [142]. The scale consists of 29 items and assesses a patient’s self-

reported degree of function of the upper extremity including shoulder, arm, and hand

activities. Items have a specified 7-day recall period, and include 5-point answer

choices, with higher scores indicating better functioning.

Exercise self-efficacy

Participants’ degree of confidence in which they can exercise in the presence of

barriers (e.g. tiredness) was evaluated using the cancer-specific Exercise Barrier Self-

efficacy Scale [143, 144]. This scale consists of nine items relating to the most

common barriers to exercise among cancer patients, with each item rated on a scale

from 0 (not confident at all) to 100% (extremely confident) at 10% intervals [145].

The barrier self-efficacy scale has a Cronbach’s alpha of 0.96, with a test–retest

correlation of 0.89 (p<0.01) [145].

Physical activity

Self-reported physical activity was assessed using the Active Australia Survey

[146, 147]. The questionnaire assesses weekly minutes of walking, moderate and

vigorous activities, and household and gardening activities (in the past seven days)

[146, 147]. All physical activity outcomes derived from the Active Australia Survey

were computed in accordance with the instrument’s scoring protocols [146, 147]. Self-

reported moderate-to-vigorous physical activity (MVPA) was calculated as the sum of

time in moderate and vigorous activities (weighted by two) [146, 147]. Total activity

was computed by adding walking, moderate and vigorous activity according to manual

instructions [148, 149]. Values greater than 1,680 minutes per week were truncated to



reduce over reporting [146, 147]. The Active Australia Survey has demonstrated

reliability (ICC=0.64) [148, 149], criterion validity (r=0.61) and is responsive to

intervention change [150]. Physical activity outcomes derived from the Active

Australia Survey were [146, 147]:

1. Minutes per week of:

a) Walking;

b) Moderate intensity activity;

c) Vigorous intensity activity;

d) Total MVPA (moderate activity + vigorous activity);

e) Total activity (walking + moderate activity + vigorous activity).

2. Proportions (n, %) of participants meeting physical activity guidelines [156] of at

least 150 minutes per week of MVPA (i.e. the intervention target of 150+ minutes

of moderate+ intensity exercise) and total physical activity.

2.5.4.14 Exploratory outcome

As a tertiary outcome of this work, barriers to the exercise intervention were

evaluated. Barriers were assessed through self-report by participants recording reasons

for missing unsupervised sessions in the exercise logbook.

2.5.4.15 Sample size

This study was an exploratory single-arm feasibility study, with a sample size of

30 previously being recommended for studies of this design [157-162]. With a sample

size of 30, there was 90% power to detect a clinically relevant change in aerobic fitness

of 25 (SD=50) metres and 75% power to detect a clinically relevant change in quality

of life of seven (SD=15) units with 5% type I error (two-tailed).

2.6 DATA MANAGEMENT AND QUALITY CONTROL

During baseline and 12-week assessments, questionnaires were collected and

reviewed for missing data by the assessor (i.e. the PhD candidate), and additional

information was obtained from the participant if required and appropriate. In instances

where participants did not complete questionnaires prior to testing, the questionnaire

was completed during the objective data collection session. During all supervised

exercise sessions, the AEP reviewed the exercise logbooks for completeness and



missing data was obtained from the participants as required. Completed exercise

logbooks were collected during the week 12 assessment.

All hard copies of the returned surveys were kept in a locked filing cabinet

accessible only to the project coordinator and supervisory team. All participants were

given an identification number, and two separate Microsoft Access databases were

created – one with participant contact information and the other with survey responses

coded by identification numbers – which enabled linkage of data over time and

between different data sources. Electronic data were kept on a password-protected

computer only accessible by the project coordinator and supervisory team.

All data were entered in a master copy of a Microsoft Access database and later

imported into SPSS for analyses. Data entry involved pre-coding of all measures and

all data were key-entered twice. An error log was generated, and all discrepancies were

checked with the original corresponding questionnaire and corrected. Frequencies

were run for all variables in the dataset to check for any invalid values and potential

outliers. Outlying or inconsistent data were assessed using statistical software and

addressed prior to data storage. Participant names and contact information were kept

separate from other data.

2.7 STATISTICAL ANALYSIS

Participant baseline characteristics were reported as means and standard

deviations for continuous outcomes or counts and percentages for categorical

outcomes. Adverse events were reported as proportions (n, %) of events for each grade

of severity. Adverse events were reported separately for exercise-related and non-

exercise-related events. Intervention feasibility was evaluated by computing retention,

adherence and compliance (as outlined in Section 2.5.4.12) and deemed acceptable

when 75% or higher for the retention, adherence and compliance criteria [121, 159,

163].

A summary of each secondary outcome, the descriptive statistics or type of

analysis used, and the values used to determine clinically relevant changes are included

in Appendix H. Secondary outcomes were analysed by comparing changes in

outcomes between pre- and post-intervention. Outcome variables were assessed for

normality using the following criteria:

1. Mean within ± 10% of median;



2. Mean ± three standard deviations and approximate the observed minimum and

maximum values;

3. Skewness and kurtosis coefficients within ± three;

4. Roughly bell-shaped histogram.

Depending on the distribution of continuous outcomes, paired two-tailed t-tests

(for normally distributed outcomes) or Wilcoxon sign-rank tests (for non-parametric

data) were used to evaluate differences between pre- and post-intervention (see

Appendix H). Chi-square tests were used to assess differences in categorical outcome

variables between pre- and post-intervention. P-values of 0.05 were used for

significance testing. Clinically relevant changes between pre- and post-intervention

were determined a priori using previously defined cut-offs. These were: >8 units for

quality of life as measured by the FACT-G scale (>2 units for each subscale) [153];

25 metres for distance walked during the 6-minute walk test [4, 164]; 10% for upper-

body strength [4], two repetitions for lower-body strength, 5% for bodyweight [165],

2% for body fat percentage [166], 1 kg/m2 for BMI [167], seven units for exercise self-

efficacy [145], 60 minutes per week of walking [168] and 30 minute per week for

MVPA [76]. For all other outcomes >1/2 SD of baseline scores was used to determine

clinically relevant cut-offs (due to absence of previously established cut-offs) [4].

These were: 8 seconds for balance, 4 units for all outcomes obtained from the

PROMIS-43, and PROMIS Global health scale short form, and 3.5 units for upper-

extremity function [4]. All statistical analyses were performed using SPSS statistics

software (Version 25, IBM Corp).



2.8 RESULTS

2.8.1 Participant flow

The CONSORT flow diagram is shown in Figure 2.1. Study recruitment took

place between December 2016 and October 2017. Two hundred and thirty-three

subjects were informed about the study. Of these, 74% (n=173) either did not meet

eligibility criteria (n=47), were uncontactable (n=85), or were not interested in

participating and eligibility status could not be determined (n=35). The most common

reasons for not meeting eligibility criteria were living greater than 60 kilometres from

Brisbane (n=15), performing >150 minutes per week of physical activity (n=13), and

diagnosed with stage I breast cancer (n=8). Among eligible participants (n=66), six

were not interested in participating. Overall, a total of 60 participants were recruited

into the wider SAFE trial (recruitment rate: 25.8%). The focus of this work (Study 1)

are the 30 participants who were enrolled to receive the 12-week exercise intervention

delivered through five supervised sessions with an AEP.



Figure 2.1 Study CONSORT flow diagram



2.8.1.1 Baseline characteristics

Baseline characteristics of the sample are shown in Table 2.10. Mean age of

participants was 49 (SD: 8.5) years and mean BMI was 28.6 (SD: 5.7) kg/m2, with

over half of the sample (63.3%, n=19) being overweight or obese. Approximately half

of the sample were diagnosed with stage II disease (46.7%, n=14), and equal

proportions had stage III and IV disease (stage II: 20%, n=6; stage IV: 20%, n=6; stage

unknown by participant, but confirmed as greater than stage I by referring nurse: n=4,

13.3%). Most participants received a mastectomy (76.7%, n=23). Nearly two-thirds of

participants (60%, n=18) had completed treatment (excluding hormone therapy) at

time of baseline assessment, while 40% (n=12) were currently undergoing treatment

during the study period. All participants received chemotherapy (100%, n=30),

approximately two-thirds received radiotherapy (66.7%, n=20) and approximately half

(46.7%, n=14) were receiving, or had received, hormone therapy.



Table 2.10

Participant baseline characteristics (n=30)

n = 30 Mean (SD) or n

(%)

Personal Characteristics

Age (years), mean (SD)

<50 years

≥ 50 years

Income, $ household year, <$75,0001

Marital status, Married/de facto

Private Health Insurance (Yes)

Body-mass index (kg/m2), mean (SD)

Body-mass index (n, %)

Healthy or underweight

Overweight

Obese

49.2 (8.6)

13 (43.3%)

17 (56.7%)

12 (40.0%)

19 (63.3%)

22 (73.3%)

28.6 (5.7)

11 (36.7%)

14 (46.6%)

5 (16.7%)

Diagnostic Characteristics

Breast cancer stage

Stage II

Stage III

Stage IV

Unsure or unknown

Side of treatment, non-dominant side

14 (46.7%)

6 (20%)

6 (20%)

4 (13.3%)

17 (56.7%)

Treatment Characteristics

Most extensive surgery

Mastectomy

Lumpectomy

No surgery

Lymph node dissection (yes)

No. of nodes removed

0

1-5

6-9

10+

Unsure or unknown

23 (76.7%)

6 (20.0%)

1 (3.3%)

28 (93.3%)

0 (0.0%)

10 (33.3%)

4 (13.3%)

12 (40.0%)

4 (13.3%)

Currently receiving treatment (yes) 12 (40.0%)

Months since treatment completion (median, min, max) (n=18) 19 (1, 47)

Treatments received

Chemotherapy (yes)

Radiotherapy (yes)

Hormone therapy (yes)

Herceptin (yes)

Immunotherapy (yes)

30 (100.0%)

20 (66.7%)

14 (46.7%)

6 (20.0%)

0 (0.0%)

Average number of side effects graded by participant as

moderate or severe in severity

2.7 (1.8)

Average number of comorbidities2 2.0 (1.7) 1 Based on cut-off for middle and high-income households (ABS Survey of Income and

Housing, 2015–16).



2 Comorbidities included cardiovascular disease, hypertension, high cholesterol, high

blood glucose, diabetes, heart attack, stroke, emphysema, chronic bronchitis, arthritis,

thyroid condition, peripheral vascular disease, osteoporosis, inflammatory condition or

asthma.

SD: Standard deviation.



2.8.1.2 Safety

Adverse events

A summary of adverse events separated by exercise and non-exercise-related is

shown in Table 2.11 (a detailed log of all adverse events is included in Appendix I).

There were 45 adverse events experienced by 18 participants during the study. Five

participants experienced one adverse event; seven participants experienced two

adverse events; while seven participants experienced three or more adverse events.

The proportion of adverse events graded as 1, 2, 3 and 4, respectively was 53% (n=24),

38% (n=17), 7% (n=3) and 2% (n=1).

Non-exercise-related adverse events (n=17 events): 12% (12%, n=4), 53%

(n=9), 18% (n=3) and 6% (n=1) of the non-exercise-related event were graded as 1, 2,

3 and 4, respectively. Approximately one quarter (23%, n=4) of the non-exercise-

related adverse events were serious events and resulted in hospitalisation (Table 2.11).

Of these four events, one event was breast cancer-specific (disease progression, n=1).

Exercise-related adverse events (n=28 events): Exercise-related adverse events

represented 62% of all adverse events. Of these, 71% (n=20) and 29% (n=8) of events

were graded as 1 and 2, respectively. The most commonly reported exercise-related

adverse event was mild delayed onset muscle soreness following exercise (n=7 events,

grade 1). No exercise-related adverse events resulted in hospitalisation. Further, there

were no exercise-related adverse events that resulted in cessation of exercise for two

or more weeks. Therefore, the criterion to establish intervention safety was met.



Table 2.11

Adverse events separated by grade of severity described as exercise and non-

exercise-related

Exercise-related adverse events1

Non-exercise-related adverse events

Grade 1 adverse events (n=20) [CTC-AE

definition2]

Grade 1 adverse events (n=4) [CTC-AE definition]

• Mild DOMS (n=7) [Myalgia]

• Foot pain following walking (n=2)

[Arthralgia]

• Light-headedness/dizziness during exercise

(n=2) [Dizziness]

• Exacerbation of bilateral knee pain associated

with existing osteoarthritis during walking

(n=1) [Arthralgia]

• Mild sudden pain in right elbow during

treadmill walking (n=1) [Arthralgia]

• Mild hip tightness (n=1) [Myalgia]

• Abdominal pain during hip extension (n=1)

[Myalgia]

• Increase in lymphoedema (n=1) [Localised

oedema]

• Pain during upper-body exercise (n=2)

[Myalgia]

• Mild lower back pain (during exercise) (n=1)

[Myalgia]

• Pain with neck flexion (n=1) [Neck pain]

• Cold and flu symptoms (n=2) [Flu-like

symptoms]

• Increased arm swelling (n=1) [Localised

oedema]

• Neck pain during daily activity (n=1) [Neck

pain]

Grade 2 adverse events (n=8) Grade 2 adverse events (n=9)

• Foot and/or leg pain following walking (n=2)

[Arthralgia]

• Swelling legs and feet (n=2) [Localised

oedema]

• Left shoulder pain (n=1) [Arthralgia]

• Lower back pain (n=2) [Myalgia]

• Increased fatigue post-exercise (completed

new exercise class) (n=1) [Fatigue]

• Virus/illness (n=4) [Other general disorder]

• Pain and swelling in hands (n=1) [Pain and

localised oedema]

• Back injury (n=1) [Back pain]

• Adverse reaction to chemotherapy (n=1)

[Nausea]

• Asthma exacerbation (n=1) [Bronchospasm]

• Right hip pain (n=1) [Pain]


Nil • Hospitalised with infection (operation to

surgically remove infection) (n=1) [Abdominal

infection]

• Appendicitis requiring surgery (n=1)

[Appendicitis]

• Virus and symptoms of pericardial pain

resulting in a referral for an echocardiogram

(n=1) [Pericarditis]


Nil • Disease progression (n=1) [Neoplasm,

malignant]


Nil Nil

Grade 1: mild symptoms; grade 2: moderate symptoms; grade 3: severe symptoms, but not immediately

life-threatening; grade 4: life-threatening symptoms; grade 5: death. 1Events were considered exercise-related if they occurred during or within two hours of completing

exercise, or as a direct result of exercise as considered by the participant and/or accredited exercise

physiologist. 2 Common terminology criteria for adverse events [97].

CTC-AE: Common Terminology Criteria for Adverse Events.

DOMS: delayed onset muscle soreness.



2.8.1.3 Feasibility outcomes

2.8.1.3.1 Retention

Of the 30 participants who were enrolled in the five supervised session

intervention, 27 women provided post-intervention data (26 completed objective

testing and self-report questionnaires, while one participant completed self-reported

assessments only), providing a retention rate of 90% (Figure 2.1). Reasons for

withdrawal (n=3) were unable to continue participating due to time constraints (n=1),

severe worsening of treatment-related side effects (n=1) and disease progression (n=1).

The one participant who could only complete the self-reported outcomes at 12 weeks

stated that time constraints prevented her from also completing objective assessments

at this time. The overall retention rate met the predefined criterion of >75%.

2.8.1.3.2 Adherence

Adherence to the five supervised sessions with an AEP: During the 12-week

intervention, the proportions of women completing 1, 2, 3, 4 or 5 of the five supervised

sessions is shown in Table 2.12. Overall, mean adherence for the group was 93% (i.e.

139 of 150 total supervised sessions were completed), and 90% of participants

attended >75% of their five scheduled sessions with an AEP (i.e. attended either four

or five of the five scheduled sessions).

Table 2.12

Adherence to participating in the supervised exercise sessions during the 12-week

intervention

Number of

supervised sessions

completed (of 5)

Number of

participants, n (%)

(n=30)

1 1 (3%)

2 1 (3%)

3 1 (3%)

4 2 (7%)

5 25 (83%)

There was a total of 1,492 sessions of aerobic exercise and 865 sessions of

resistance exercise (including supervised sessions) that were prescribed across all

participants (Table 2.13). Participants completed 70.1% (1,047 of the 1,492) of



prescribed aerobic exercise sessions and 71.5% (619 of the 856) of prescribed

resistance exercise sessions. Overall, participants completed 70.7% of all prescribed

exercise sessions (1,666 of 2,357). As such, adherence to all prescribed sessions did

not meet the predefined criteria of >75%.

Table 2.13

Adherence to prescribed exercise sessions, presented as weekly sessions and total

number of prescribed sessions during the intervention

Completed

Prescribed

Adherence1

Total no. of sessions during the 12 weeks

Aerobic exercise sessions

Resistance exercise sessions

All exercise sessions

1,047

619

1,666

1,492

865

2,357

70.1%

71.5%

70.7% 1 Adherence = Total no. of sessions completed ÷ total no. of sessions prescribed.

2.8.1.3.3 Compliance

Overall, mean total moderate or high intensity exercise performed was 127.3

(64.8) minutes per week of the target >150 minutes per week (median [minimum,

maximum]: 124.7 [7.92, 247.4]). This represented 84.8% of the weekly target. Mean

minutes per week of moderate or high intensity aerobic exercise was 71.4 (SD=36.7)

and mean minutes per week of moderate intensity resistance exercise was 55.9

(SD=27.8).

Individual plots of minutes of moderate or high intensity exercise performed

during each of the 12 weeks are shown in Figure 2.2. This figure shows that average

minutes of weekly moderate or high intensity exercise undertaken per participant

ranged from 8 to 247 minutes (median=125) throughout the 12-week intervention

duration. Further, 37% and 74% achieved the >150-minute weekly target and 75% of

the >150-minute weekly target (i.e. 113 minutes per week) in every week of the

intervention, respectively. Mean (SD) minutes per week of moderate intensity exercise

that was performed during each of the 12 weeks are shown in Figures 2.3 (see

Appendix J for a graph of median [interquartile ranges] minutes per week). The group

mean calculated for each week remained between 100 and 150 minutes per week

during the 12 weeks, with the highest mean observed in week three (mean=146.2



minutes per week, SD=88.9), and lowest mean in week 12 (mean=104.0 minutes per

week, SD=108.9). Also, as can be seen in Figure 2.3, the weekly means never hit the

150+ minute weekly target. This is more comprehensively explained by looking at

individual compliance of the participants who completed the study:

• four (13%) participants had a weekly prescription that was purposefully

less than the target;

• two participants (7%) never met the weekly target;

• ten (37%) participants were performing on average 150 minutes or more

each week of moderate or high intensity aerobic and resistance exercise;

• 17 (63%) were performing, on average, less than 150 minutes per week

of moderate intensity exercise (i.e. between 12 to 14 RPE)

• 59% of participants (n=16) met the 150 minute per week intervention

target in nine of the 12 weeks (i.e. 75% of the 12 weeks)

• 20 (74%) participants performed on average 75% of the weekly target

(i.e. 113 minutes/week).

81

Figure 2.2 Individual participant plots of minutes of moderate intensity aerobic and resistance exercise (Rating of Perceived Exertion: 12 to 14)

that was performed during each of the 12 weeks

Week

Min

ute

pe

r w

ee

k o

f ex

erc

ise

150 minute per week intervention target

113 minutes per week (75% of intervention target)

82 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage II+ breast cancer (Study 1, the SAFE study)

Figure 2.3 Mean (standard deviation) minutes per week of moderate intensity aerobic and resistance exercise (Rating of Perceived Exertion 12 to

14) that was performed during each of the 12 weeks.

Week Week 150 minute per week intervention target

113 minutes per week (75% of intervention target)

83

2.8.1.3.4 Summary of feasibility outcomes

A summary of all feasibility results is shown in Table 2.14. Overall, the three

feasibility criteria (retention, adherence, compliance) were met.

Table 2.14

Summary of feasibility outcomes

Feasibility outcome Study result Predefined

criterion

Met

predefined

criterion?

Retention 90% >75% Yes

Adherence1

a. Adherence to 5 supervised sessions

b. Adherence to all prescribed exercise

sessions2

87%

68%

>75%

>75%

Yes

No

Compliance3

a. Compliance to weekly intervention

target (percentage of the 150 minutes per

week that participants averaged)

b. Proportion (%) of participants

performing on average >150 minutes or

more each week

c. Proportion (%) of participants who met

the weekly intervention target >75% of the

time

d. Proportion (%) of participants that

averaged at least 113 minutes per week

85%

37%

59%

74%

>75%

>75%

>75%

>75%

Yes

No

No

No 1 At least one of the two adherence criteria must be met for the intention to be feasible. 2 Includes all prescribed supervised and unsupervised exercise sessions. 3 At least two of the four criteria under compliance must be met for the intervention to be

feasible.




Aerobic fitness, strength, balance, body weight, body fat and BMI

Changes in aerobic fitness, strength, balance, body weight, body fat and BMI

between pre- and post-exercise intervention are shown in Table 2.15. Between baseline

and 12 weeks, there were clinically relevant improvements in aerobic fitness (p<0.05)

and upper body strength (p=0.04). Lower body strength showed a statistically

significant change (p<0.05), although the effect was not clinically relevant. No

significant changes were observed in balance, body weight, body mass index or body

fat.

85

Table 2.15

Change in fitness, strength, balance, bodyweight and body mass index between pre- and post-exercise intervention

Outcome Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)

Change from baseline to

12 weeks Mean (95% CI)

p-value

Aerobic fitness (distance

walked, metres) 1

508.7 (478.3, 539.1)

562.5 (539.1, 585.9)

53.7 (29.5, 77.9)ǂ

<0.01

Upper body strength (no. of

repetitions) 1

27.2 (20.2, 34.2)

32.3 (22.2, 42.4)

5.1 (0.2, 10.0)ǂ

0.04

30 second sit-to-stand (no. of

repetitions) 1

11.2 (10.12, 12.4)

12.8 (11.6, 14.0)

1.5 (0.2, 2.9)

0.02

Balance1 7.8 (4.3, 11.3) 13.4 (4.9, 22.1) 5.6 (-2.9, 14.2) 0.20

Body weight (kg) 79.4 (73.0, 85.9) 79.4 (72.4, 86.5) 0.0 (-1.6, 1.6) 0.99

Body fat (%) 37.2 (34.6, 39.7) 38.0 (35.7, 40.3) 0.8 (-0.8, 2.5) 0.31

Body mass index (kg/m2) 29.0 (26.9, 31.1) 29.1 (27.1, 31.2) 0.1 (-0.6, 0.9) 0.68 1 Increase represents an improvement.

ǂ Clinically relevant change.



Quality of life

FACT-G (Table 2.16): Between pre- and post-intervention, a clinically and

statistically significant improvement was observed in overall quality of life (total

FACT-G score, p<0.01) and in the functional wellbeing domain (p<0.01). Physical

(p=0.03) and emotional wellbeing domains (p=0.04) showed statistically significant

improvements, although the magnitude of change was not clinically relevant. No

change was observed in social wellbeing (p=0.87).

PROMIS questionnaires (Table 2.17): Clinically relevant improvements were

observed in physical health, physical function, depression, fatigue and satisfaction

with social roles, all of which were supported statistically (all p<0.05). Although not

clinically relevant, statistically significant improvements were observed in mental

health, anxiety, sleep and pain (all p<0.05). There was no change in self-reported

upper-extremity function.

87

Table 2.16

Change in quality of life (FACT-G) outcomes between pre- and post-exercise intervention

FACT-G outcome1 Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)

Change from baseline to 12 weeks

Mean (95% CI)

p-value

Overall quality of life2 73.5 (68.6, 78.5) 80.9 (74.8, 86.9) 7.3 (2.8, 11.8)ǂ <0.01

Physical wellbeing 19.0 (17.4, 20.5) 20.7 (18.8, 22.7) 1.7 (0.1, 3.3) 0.03

Social wellbeing 20.8 (19.0, 22.5) 20.9 (18.6, 23.1) 0.1 (-1.4, 1.7) 0.87

Emotional wellbeing 16.9 (15.4, 18.5) 18.5 (17.1, 19.9) 1.5 (0.1, 3.1) 0.04

Functional wellbeing 16.8 (15.0, 18.5) 20.6 (18.8, 22.5) 3.8 (2.3, 5.4)ǂ <0.01 1 Higher scores indicate higher quality of life. 2 Overall quality of life represents total FACT-G score.

ǂ Clinically relevant change.

FACT-G: Functional Assessment of Cancer Therapy-General.


Table 2.17

Change in PROMIS questionnaire results between pre- and post-exercise intervention

PROMIS outcome1 Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)


Mean (95% CI)

p-value

Overall 140.0 (129.2, 150.9) 164.6 (154.3, 174.9) 24.5 (14.7, 34.3) <0.01

Physical function 22.6 (20.7, 24.6) 25.7 (24.2, 27.2) 3.1 (1.8, 4.3)ǂ <0.01

Anxiety 22.7 (20.9, 24.4) 24.7 (22.7, 26.6) 2.0 (0.1, 3.9) 0.04

Depression 24.3 (22.4, 26.2) 27.1 (25.6, 28.4) 2.7 (0.9, 4.5) <0.01

Fatigue 15.6 (13.5, 17.7) 20.1 (18.1, 22.1) 4.5 (2.0, 6.9)ǂ <0.01

Sleep 16.5 (14.4, 18.6) 20.0 (17.7, 22.2) 3.4 (1.2, 5.6)ǂ <0.01

Pain interference 21.8 (19.4, 24.1) 24.6 (22.4, 26.9) 2.8 (0.6, 5.1) 0.01

Social roles 16.3 (13.9, 18.8) 22.1 (20.0, 24.2) 5.7 (3.4, 8.1) <0.01

Upper extremity 75.0 (72.3, 77.6) 75.4 (72.6, 78.1) 0.4 (-2.0, 2.9) 0.75

Physical health 41.0 (38.2, 43.8) 46.4 (44.1, 48.7) 5.3 (2.9, 7.8)ǂ <0.01

Mental health 43.0 (40.4, 45.5) 46.6 (43.9, 49.3) 3.6 (1.2, 6.0)ǂ <0.01 1 Higher scores indicate higher quality of life.


ǂ Represents a clinically relevant change.

89


There was no change in exercise self-efficacy (p=0.80) between baseline and

post-intervention (Table 2.18).

Table 2.18

Change in exercise self-efficacy between baseline and post-intervention

Self-efficacy

Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)

Change from baseline to

12 weeks

Mean (95% CI)

p-value

Mean (0-100) 43.6 (37.3, 49.9) 42.7 (36.5, 48.9) –0.8 (–7.9, 6.1) 0.80 1 Higher scores represent higher represents exercise self-efficacy.

Physical activity

Duration (minutes per week) and frequency (number of >10 minute bouts per

week): Minutes per week of self-reported physical activity at baseline and 12 weeks

are shown in Table 2.19. Statistically and clinically significant increases were

observed in walking (p=0.01) and total activity (p=0.02). There was a clinically

relevant increase in moderate-intensity activity (52.3 minutes per week), vigorous

intensity activity (44.5 minutes per week) and total MVPA (123.6 minutes per week),

although these findings were not supported statistically (all p>0.05).


Table 2.19

Minutes per week of self-reported physical activity at baseline and 12 weeks

Minutes per

week

Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)

Change from baseline

to 12 weeks

Mean (95% CI)

p-value

Walking 81.7 (54.5, 108.9) 160.0 (109.4, 210.5) 78.2 (16.1, 140.4)ǂ <0.01

Moderate

intensity activity

46.1 (–6.37, 98.7)

98.5 (32.8, 164.2)

52.3 (-36.1, 140.8)

0.24

Vigorous

intensity activity

53.0 (9.91, 96.0)

97.5 (48.5, 146.6)

44.5 (-14.9, 104.1)

0.14

Total MVPA1 99.1 (20.9, 177.4) 222.7 (102.0, 343.5) 123.6 (-27.3, 274.5)ǂ 0.10

Total activity2 178.5 (83.3, 273.6) 380.5 (251.1, 509.9) 202.1 (27.3, 376.8) ǂ 0.02 1 Does not include walking (moderate activity + vigorous activity). 2 Includes time spent walking (walking + moderate activity + vigorous activity).

MVPA: Moderate to vigorous intensity physical activity.

91

Proportions meeting physical activity guidelines at baseline and 12 weeks (Table

2.20): At 12 weeks, 48.1% (n=13) and 85.2% (n=23) of participants were meeting

National Physical Activity Guidelines based on self-reported MVPA (moderate-

intensity activity + vigorous-intensity activity) and total activity (moderate-intensity

activity + vigorous-intensity activity + walking) respectively.

Table 2.20

Proportions meeting physical activity guidelines at baseline and 12-weeks

Minutes per

week

Meeting at

baseline

n=27

Meeting at 12

weeks

n=27

Chi-square p-value

MVPA1 5 (18.5%) 13 (48.1%) 0.16 0.68

Total

activity2

10 (37.0%)

23 (85.2%)

0.33

0.56 1 Does not include walking (moderate activity + vigorous activity). 2 Includes time spent walking (walking + moderate activity + vigorous

activity).

MVPA: Moderate to vigorous intensity physical activity.

2.8.1.4.1.1 Exploratory analyses of secondary outcomes

For the outcomes that showed a clinically and statistically significant

improvement, the proportions of participants that showed a clinically relevant

improvement, no change or worsening are shown in Table 2.21.



Table 2.21

Proportions of participants that showed a clinically relevant improvement, no

change or worsening in secondary outcomes

Proportion of participants that showed a clinically

relevant improvement, no change or worsening

Outcomes Improvement1

n (%)

No change2

n (%)

Worsening3

n (%)

Aerobic fitness, n=24 17 (70.8%) 1 (4.2%) 6 (25.0%)

Upper body strength, n=23 13 (56.5%) 6 (17.4%) 4 (26.1%)

30 second sit-to-stand, n=24 11 (45.8%) 8 (33.3%) 5 (20.8%)

Balance, n=24 9 (37.5%) 11 (45.8%) 4 (16.7%)

Body weight, n=24 8 (33.3%) 5 (20.8%) 11 (45.8%)

Body fat, n=24 4 (16.7%) 9 (37.5%) 11 (45.8%)

Body mass index, n=24 5 (20.8%) 11 (45.8%) 8 (33.3%)

FACT-G overall quality of life, n=26 15 (57.7%) 8 (30.8%) 3 (11.5%)

Physical wellbeing, n=26 12 (46.2%) 10 (38.5%) 4 (15.4%)

Social wellbeing, n=26 13 (50.0%) 8 (30.8%) 5 (19.2%)

Emotional wellbeing, n=26 13 (50.0%) 10 38.5%) 3 (11.5%)

Functional wellbeing, n=26 10 (38.5%) 12 (46.2%) 4 (15.4%)

PROMIS overall quality of life, n=28 13 (46.4%) 12 (42.9%) 3 (10.7%)

Physical function, n=28 17 (60.7%) 11 (39.3%) 0 (0%)

Anxiety, n=28 16 (59.3%) 9 (33.3%) 2 (7.4%)

Depression, n=28 14 (50.0%) 11 (39.3%) 3 (10.7%)

Fatigue, n=28 19 (67.9%) 5 (17.9%) 4 (14.3%)

Sleep, n=28 13 (46.4%) 11 (39.3%) 4 (14.3%)

Pain interference, n=28 11 (39.3%) 14 (50.0%) 3 (10.7%)

Social roles, n=28 14 (50.0%) 12 (42.9%) 2 (7.1%)

Upper extremity, n=28 10 (35.7%) 14 (50.0%) 4 (14.3%)

Physical health, n=28 16 (59.3%) 9 (33.3%) 2 (7.4%)

Mental health, n=28 13 (46.4%) 12 (42.9%) 3 (10.7%)

Self-efficacy, n=28 11 (39.3%) 15 (53.6%) 2 (7.1%)

Walking, n=27 16 (59.3%) 7 (25.9%) 4 (14.8%)

Moderate intensity activity, n=27 22 (81.5%) 3 (11.1%) 2 (7.4%)

Vigorous intensity activity, n=27 17 (63.0%) 8 (29.6%) 2 (7.4%)

Total MVPA1, n=27 20 (74.1%) 4 (14.8%) 3 (11.1%)

Total activity2, n=27 21 (77.8%) 1 (3.7%) 5 (18.5%) 1 Number of participants that showed a clinically relevant improvement. 2 Number of participants that showed no clinically relevant change. 3 Number of participants that showed a clinically relevant worsening.

93

2.8.1.5 Exploratory outcome

Exercise barriers

An overview of all barriers to exercise experienced by participants, that

contributed to missing of scheduled exercise sessions is shown in Table 2.22. There

was a total of 26 barriers identified, of which 12 were health or medical-related. The

most common health or medical-related barrier was fatigue, which was reported by 22

participants at least once during the intervention, while 10 participants reported illness

or feeling unwell. The most common non-health or medical-related barriers that

participants reported were being busy (n=12), family reasons (n=11) and poor time

management or poor planning of exercise (n=9).

Table 2.22

Barriers to exercise, separated as health or medical-related and non-health or

medical-related reasons

Barriers to exercise

26 total barriers

Health or medical-related reasons

12 total barriers (n= number of

participants1)

Non-health or medical-related reasons

14 total barriers (n= number of participants1)

1. Fatigue (n=22) 1. Busy (n=12)

2. Illness/unwell (n=10) 2. Family commitments (n=11)

3. Medical appointments (n=4) 3. Poor time management (n=9)

4. Insomnia or lack of sleep (n=2) 4. Travel/holidays (n=8)

5. Feeling low (n=1) 5. Work reasons (n=7)

6. Pain (n=1) 6. Lack motivation (n=7)

7. Surgery (n=1) 7. Weather (n=4)

8. Back injury (n=1) 8. Social activities (n=4)

9. Asthma (n=1) 9. Carer/household duties (n=4)

10. Sore feet (n=1) 10. Sick children (n=1)

11. Medical procedure (biopsy) (n=1) 11. Did not feel like exercise (n=1)

12. Disease progression (n=1) 12. Unspecified personal reasons (n=1)

13. Lack support (n=1)

14. Other (n=1) 1 Number of participants that experienced this barrier at least once during the 12 weeks.



2.9 DISCUSSION

Key findings from this study were: (1) an exercise intervention delivered in

accordance with the level of supervision provided under the current Medicare CDMP

was implemented safely for all, feasibly for some, and (2) participating in the

intervention was associated with mean improvements in quality of life, aerobic fitness,

muscle strength and self-reported physical activity levels. The novel aspects of these

findings include the evaluation of a pragmatic exercise intervention that specifically

targeted a subgroup of the breast cancer population that has been underrepresented in

previous exercise trials.

2.9.1.1 Primary outcomes

2.9.1.2 Safety (adverse events)

Exercise-related adverse events were infrequent and those events that presented

were mild and commonly musculoskeletal in nature (>75%). Further, 25% (n=7) of

events were normal physiological responses to exercise progression and overload (e.g.

muscle soreness). No exercise-related adverse events resulted in exercise cessation for

two or more weeks or referral to a health or medical professional for outside

intervention. However, approximately one-third of general events (39%, n=11 events

in 8 participants) resulted in exercise modification, such as lowering of exercise

intensity, duration or frequency or substitution of a particular exercise. All exercise-

related adverse events occurred across a variety of time points during the intervention

(57% occurred during the first half of the intervention and 43% occurred during the

second half) and were not associated with exercise mode (28% occurred during or

following aerobic exercise, 36% occurred during or following resistance exercise and

37% occurred during or following a combined aerobic and resistance exercise session).

Although these findings suggest adverse event risk was minor (including during the

early stages of an exercise intervention), it needs to be remembered that sessions with

the AEP included safety education, emphasis on the importance of incorporating

warm-ups and cool-downs into each session, as well as clear instruction (supported

when necessary by written material) regarding safe performance of specific exercise

technique (e.g. how to measure intensity, how to perform a particular strength exercise

properly). Also, the number of adverse events (irrespective of their relationship with

exercise) that occurred across the entire duration of the intervention highlights the need

95

for provision of exercise advice and support by qualified allied health professionals in

this particular subgroup of women with breast cancer.

Adverse events have typically been poorly reported in previous trials (if at all),

with a recent systematic review indicating that fewer than half of cancer and exercise

trials adequately report on adverse event monitoring and occurrence [83]. Two

previous 12-week RCTs (n=222 [169] and n=242 [60]) reported adverse events rates

of less than 10%, most of which were musculoskeletal (e.g. muscle pain or soreness)

in nature following interventions involving one to three supervised sessions per week

during [60] and following treatment [169] in similarly aged samples compared with

SAFE participants (mean age= 50 to 60 years). However, the level of supervision in

SAFE was much lower compared with these two trials (five supervised sessions

compared with 12 to 36 sessions over 12 to 52 weeks). SAFE also involved women

with more advanced disease, other comorbidities or persistent treatment-related

effects.

Even though all exercise-related adverse events were low-grade (i.e. grade 1 or

2) and did not affect participation, there was a higher number of adverse events in

SAFE compared with two previous published trials that involved individuals with

advanced cancer [113, 170]. Both of these trials involved participating in aerobic

exercise, with [170] or without [113] resistance-based exercise. One trial lasted 6

weeks [170] whereas the other lasted 16 weeks [113] in duration, and both involved

weekly supervision. The differences in adverse event rate between SAFE and these

other two previous trials may be attributed to several reasons. First, SAFE involved

lower supervision and contact, which may have meant less capacity for the AEP to

monitor symptom changes and minimise adverse event risk [171, 172]. Second, safety

was not an outcome in the previous trials. Therefore, it is possible that adverse events

were not comprehensively monitored and recorded, thereby increasing the likelihood

of missing the less severe adverse events. In contrast, adverse events were a primary

outcome of SAFE, and comprehensive protocols for monitoring and recording all

adverse events were implemented. Participants were advised to report all adverse

events that occurred during unsupervised exercise. During supervised sessions, the

AEP routinely asked about adverse events, which may have prompted participants to

recall and report minor adverse events (that they may not otherwise have recalled or

documented if the participant had not been specifically asked to do so). Finally, low to



moderate intensity aerobic-exercise (walking) [113] and shorter interventions (six

weeks [170]) were evaluated in previous work, whereas SAFE involved moderate-to-

high intensity aerobic and resistance-based exercise for 12 weeks. Overall, the

frequency (total number) of events in SAFE was higher than previously reported in

trials involving participants with stage IV cancer [113, 170]. However, the nature and

severity of exercise-related events (i.e. low-grade musculoskeletal symptoms) that

occurred in SAFE were similar to previous trials involving predominantly women with

early-stage disease and high volume of supervision [60, 169]. Consequently, these

findings suggest that moderate to high intensity exercise prescription (along with

behaviour change education advice) provided under the reimbursable model in

Australia is associated with safe exercise, even for women with stage II+ disease who

are physically inactive and have multiple comorbidities and treatment-related side

effects.

2.9.1.3 Feasibility

Retention and adherence to supervised sessions in SAFE was high (>80%);

however, compliance was variable.

2.9.1.4 Retention

Retention rates of 93 to 97% have previously been reported in studies that have

involved intervention durations of 8 weeks to 8 months (n=108 to 222), including one

to three supervised sessions each week [4, 169, 173, 174]. As such, the retention rate

of 90% in SAFE was similar to that reported in previous trials. Of note, these trials

have included samples that have been treated with curative intent (i.e. majority had

stage I disease). Nonetheless, not all breast cancer and exercise trials have reported

high retention. Specifically, 70% retention was reported in a 16-week RCT (n=101)

that evaluated a home-based exercise intervention among women with stage IV

(metastatic) breast cancer [113] and 65% in a 6-week non-randomised study (n=26)

that evaluated supervised exercise among advanced cancer patients (n=7, 27% with

breast cancer) [170]. In both trials [113, 170], disease progression was the reason for

most withdrawals (65 to 100%). Withdrawals due to disease progression in SAFE were

lower (n=1, 3%), which may be because the SAFE sample comprised only 20% (n=6)

of participants with stage IV disease, compared with 100% in these previous two trials

97

[113, 170]. Based on previous findings, due to the higher disease burden and high risk

of disease progression in stage IV disease, retention in an exercise trial may not be as

feasible and well tolerated, and may require higher levels of supervision to ensure

participants are highly supported.

Adherence

Findings from the systematic review and meta-analysis undertaken as part of this

PhD (Section 2.2) found a median adherence rate of 82% (range: 44 to 99%) in

exercise trials involving women with stage II+ breast cancer. Similarly, in previous

RCTs targeting women with early-stage disease, adherence has been reported at 70 to

98% during and following treatment [60, 61, 175-179] for 8-week to 8-month exercise

interventions involving one to three supervised sessions per week [4, 169, 173, 174].

Adherence to unsupervised, home-based interventions has also been high, with 72%

[180] and 76% [181] adherence reported in 6- and 12-week interventions involving

three to six unsupervised sessions per week [180, 181]. Adherence to the supervised

sessions in SAFE was high (87%); however, the number of supervised sessions in

SAFE (five sessions) was much lower compared with other supervised trials (which

included 12 to 52 supervised sessions over 12 to 52 weeks). In SAFE, adherence to

unsupervised sessions (68%), although lower than adherence to the supervised

sessions, was comparable to adherence reported in previous unsupervised

interventions (61 to 72%) conducted over 12 weeks [181, 182].

2.9.1.5 Compliance

Based on the first compliance criteria for SAFE, which showed that the mean

minutes of exercise completed by the group was 83% of weekly target, the SAFE

intervention could be deemed as feasible, which is in line with feasibility findings

reported in previous studies involving home- and facility-based interventions of

aerobic and resistance exercise among women with breast cancer (78 to 98%) [60, 113,

173, 175, 183]. However, a closer look at who completed what throughout the 12-

week SAFE intervention period suggests that this intervention was feasible for some,

but not all. Specifically, only one-third of the women were engaging in an average of

150 minutes or more of moderate-intensity exercise each week. Even when feasibility

criteria are lowered to meet 75% of the weekly target for the entire 12week



intervention period, one-third of the sample were still unable to meet this target.

Further, two participants (7%) never met the weekly target, and a further four (13%)

women were purposefully prescribed a weekly prescription that was less than the

target. Nonetheless, 60% of the sample were able to meet the 75% of the weekly

exercise target for nine out of the 12 weeks. Additionally, compared with participants

who had completed treatment, participants who were currently undergoing treatment

during the study were more commonly prescribed a lower exercise dose (i.e., duration

and intensity) and more frequent adjustments to their exercise prescription due to

regular changes to treatment-related effects (e.g., fatigue, Table 2.22). These

compliance findings support the notion that patients are likely to have ‘good’ and ‘bad’

weeks with respect to meeting exercise targets. There is also need for flexibility in the

exercise prescription, acceptance of what is achievable and when, and promotion that

the goal is to progress towards and, when appropriate, meet as often as possible, what

are currently being promoted internationally as weekly physical activity targets for all

women with breast cancer.

Compliance was highest in the first few weeks of the intervention, with this

period coinciding with the weeks typically involving the highest levels of supervision

(100% [n=30] of participants had a supervised session in week two; 96% [n=29] had

a supervised session in week 2; and 73% [n=22] had a supervised session in week 3).

This supports previous work suggesting that compliance may be highest in the initial

phases when commencing exercise, and during periods when supervision is more

frequent and motivation is likely at its highest [184, 185]. As such, consideration of

when and how often supervised sessions are provided is an important factor. This

requires an individualised approach with consideration for safety, feasibility and

effectiveness expectations or needs, in addition to what is required for longer-term

behaviour change. The current problem in the Australian context is that AEPs are

likely limited to five sessions with a patient each year. SAFE findings also suggest that

participants who met the intervention target in week 1 (n=6) averaged 147.7 (SD: 57.4)

minutes per week during the entire 12-week intervention, while participants who did

not meet the intervention target in week 1 (n=21) averaged 115.4 (SD: 66.1) minutes

per week during the intervention. Therefore, for those reporting high compliance in

week 1, it may be worthwhile spreading out additional sessions over the 12-week

period, whereas for those with low compliance in week 1, more frequent sessions early

99

may assist. Until more research can provide guidance on this, clinical judgement is

required to determine when these sessions would be optimally scheduled.

Compliance did not reach the predefined criteria although the intervention was

still associated with improvements in secondary outcomes. Greater improvements in

secondary outcomes may have occurred if compliance had been higher. That is,

completing at least 75% of the intervention was feasible at the group level, although

there were a range of responses at the individual level. The sample in this study

included both over and under exercisers (average minutes of weekly exercise at or

above the target intensity ranged from eight to 247 minutes per week). When looking

at compliance at the individual level, there were individuals who had high and low

compliance. Sixteen participants (n=16, 59%) met the intervention target for nine of

the 12 weeks (i.e. 75% of 12 weeks), and 20 participants (74%) averaged at least 113

minutes per week (i.e. 75% of 150 minutes per week) over the 12 weeks. The

importance of looking at these markers of compliance is that they acknowledge that

participants may have had a ‘bad week’ (i.e. experienced various barriers and could

not meet the intervention target). Nevertheless, they were able to make up for it in

another week, so that their overall compliance during the 12 weeks was considered.

Importantly, in cases where it was not feasible for participants to be completing 150

minutes per week, an individualised approach was important and appropriate. This

therefore highlights the question as to whether 150 minutes is appropriate for all

women, particularly those with stage II+ breast cancer who are physically inactive with

multiple treatment-related side effects and/or comorbidities.


The intervention was associated with clinical and statistical improvements in

mean aerobic fitness, upper body strength, overall quality of life, functional wellbeing,

physical health and function, depression, fatigue and satisfaction with social roles.

Statistically significant improvements were also observed in lower body strength,

physical wellbeing, emotional wellbeing, mental health, anxiety, sleep disturbance and

pain, although these were not considered clinically relevant findings.

Health-related outcomes

The improvements in health-related outcomes are consistent with the findings

from the meta-analysis of exercise trials among women with stage II+ breast cancer



(Section 2.2), which showed significant effects on quality of life, aerobic fitness,

fatigue, strength, anxiety, depression, body mass index (SMD range: 0.17 to 0.77,

p<0.05). The findings are also consistent with findings of previous systematic reviews

and meta-analyses involving predominantly women with early-stage breast cancer [83,

87, 98-105, 186, 187]. Specifically, in a meta-analysis [187] of 33 RCTs including

2,659 women with breast cancer, predominantly with early-stage disease,

improvements in muscle strength, mental health, depression, anxiety, body mass

index, body fat and pain (all p<0.05) were reported with exercise.

Compared with previous trials [169, 188] greater increases were observed for

quality of life and aerobic fitness following participation in SAFE. Previous supervised

RCTs have reported 3 to 4-unit improvements in FACT-G score [169, 188], and

improvements in the range of 26 to 35 metres for the 6-minute walk test following 12-

week supervised exercise interventions [137, 189]. In contrast, quality of life (assessed

using the FACT-G) increased by 7 units, and 6-minute walk test distance increased by

54 metres in SAFE. Unlike the samples in previous trials [137, 169, 188, 189], SAFE

involved participants with stage II+ disease who were physically inactive and

considered to have a high disease burden. As such, the low baseline quality of life and

fitness levels may have meant that there was greater potential for improvements

through exercise compared with previous trials. In SAFE, no changes were observed

in exercise self-efficacy, self-reported upper-extremity function, social wellbeing,

balance, body weight, body mass index or body fat. Findings from systematic reviews

and meta-analyses of adequately powered RCTs [83, 87, 98-105], including the meta-

analysis from this chapter, have shown improvements in these outcomes. It therefore

seems plausible that higher amounts of supervised sessions than what was provided as

part of the SAFE intervention may be required to change these outcomes. Of note,

body weight remained stable in the SAFE sample. This could be considered in contrast

to what has been reported previously, with increases in body weight post-breast cancer

common. However, when taking the characteristics of the sample into account

(including duration since diagnosis), alongside relatively short duration of assessment

period, and given the intervention involved increases in energy expenditure, a stable

in this population is expected. However, it is also possible that a significant

improvement in at least some of these outcomes may not have been expected in SAFE.

For example, improving balance and coordination was not a priority for the exercise

101

prescription in SAFE; the SAFE intervention was not group-based which likely limited

any potential social wellbeing improvement; and SAFE did not involve any

intervention or education relating to energy balance or diet, likely limiting any

potential change in body composition or bodyweight [42, 190, 191]. Moreover,

baseline self-reported upper-extremity function was high which may have limited the

ability to observe improvements in this outcome. One outcome change (or lack

thereof) that is more difficult to understand relates to exercise self-efficacy.

Considering the increases observed in physical activity levels for women in SAFE,

increases in exercise self-efficacy were expected. Although more frequent contact with

an AEP may be required to significantly enhance self-efficacy. It is nonetheless

possible that the small sample size, or mixed disease stages (i.e. stages II, III and IV)

and treatment characteristics (e.g. undergoing radiotherapy or chemotherapy, or

completed active treatment), length of intervention, as well as the multiple

comorbidities and side effects influenced the ability to observe changes in various

health-related outcomes.

It is also important to highlight that changes in group means distort any effects

that occur at the individual level. Specifically, even though between 17 and 78%

showed clinically relevant improvements in health outcomes assessed between pre-

and post-intervention, between 4 and 54% failed to show any effect or showed

worsening in these outcomes. As such, these individual changes show that providing

exercise advice and support through five sessions with an AEP was insufficient to

improve patient-relevant outcomes for a significant subgroup of this population.

Further research is required to better understand the difference between those

individuals who do or do not respond. That is, future research could investigate

whether responses to exercise training are influenced by specific personal or disease

characteristics, feasibility to supervised or unsupervised sessions, age, baseline

outcomes or other factors.

Physical activity outcomes

Participation in SAFE was associated with increases in walking (78 minutes per

week) and total activity (202 minutes per week), and an increase in total MVPA (124

minutes/week). A previous trial reported an increase of 68 minutes per week and 129

minutes per week in objectively measured and self-reported (respectively) moderate

intensity physical activity during a 12-week RCT (n=222) involving a home-based



intervention consisting of supervised sessions and face-to-face counselling [169].

Similarly, a 62 minute per week increase in moderate intensity exercise was reported

in an RCT (n=101) involving women with stage IV (metastatic) breast cancer (42% of

who were undergoing chemotherapy at the time of enrolment), following a 16-week,

home-based aerobic exercise intervention [113]. These previous interventions

delivered approximately 1500 minutes of intervention support over a 12-week

intervention period [113] and the home-based trial provided up to 11 phone calls

totalling up to 500 minutes of intervention support over a 16-week intervention period

[169]. In comparison, the five supervised sessions delivered as part of SAFE equated

to approximately 300 minutes of intervention contact with an AEP. As such, despite

the lower amount of AEP contact in SAFE, similar increases in physical activity levels

were observed at the 12-week follow-up.

Of note, the eligibility criteria for SAFE involved performing less than 150

minutes per week of moderate intensity physical activity. Therefore, no participants

were meeting national physical activity guidelines at the time of eligibility screening.

However, five participants were meeting these guidelines at baseline. This is likely

attributed to two reasons: 1) there were different self-report questionnaires

administered to determine eligibility (non-standardised questions regarding weekly

physical activity levels) compared with baseline physical activity assessment, which

used the Active Australia survey; and 2) implementation of the intervention involved

participants commencing their intervention in blocks (i.e. waves) throughout the year.

Therefore, the time between eligibility screening and intervention commencement was

up to two weeks for some participants. During this period, participants may have

increased physical activity participation and, as a result, the physical activity results

observed at the 12-week follow-up assessment are likely to be in the conservative

direction.

2.9.2 Exploratory outcome

2.9.2.1 Barriers to exercise

Addressing barriers that affect adherence to prescribed frequency, intensity,

duration, and progression is not only necessary to optimise compliance during an

exercise intervention period, but also for developing and sustaining sufficient levels of

physical activity beyond the intervention period. The most common health- or

medical-related barriers to exercise participation reported by participants were fatigue

103

(n=22) and illness or feeling unwell (n=10). The most common non-health or medical-

related barriers included being busy (n=11), family reasons (n=11) and poor time

management or poor planning of exercise (n=9). These barriers are similar to those

reported previously in the literature. The presence of treatment-related side effects,

such as fatigue, alongside non-cancer-related barriers (including those experienced by

people with other chronic disease as well as healthy populations, such as time

constraints, holidays, family reasons and transportation issues) represent the key issues

influencing exercise participation [60, 183]. Participants in SAFE experienced either

health or medical-related (including breast cancer-related) barriers and general

barriers. Younger participants were less likely to report treatment-related side effects

as barriers to exercise, and instead were more likely to report barriers related to their

employment, time-constraints and family. In contrast, older participants were more

likely to report medical or health-related barriers such as fatigue and feeling unwell or

illness. Similarly, barriers related to treatment-related side effects, other medical or

health-related barriers and reasons relating to current treatments and hospital

appointments were more commonly experienced by participants who were currently

undergoing active treatment (e.g., fatigue, pain, feeling unwell and medical

appointment, Table 2.22). In contrast, participants who were post-treatment generally

reported reasons related to employment, time-constraints and family (e.g., being busy,

family commitments, travel/holidays, work reasons, Table 2.22). In SAFE,

identification of barriers and motivators, as well as discussion around overcoming

barriers, was considered just as important as exercise prescription (and discussion of

safety and education). Further, helping women to understand how to modify their

exercise prescription to account for barriers was considered a particularly effective

strategy. Clearly, discussions around identifying and overcoming barriers requires an

individualised approach based on various personal, medical and lifestyle factors and

experiences.

2.10 LIMITATIONS

The findings reported above come from a pre-post-intervention trial, whereby

only association rather than causation can be inferred. Further, the AEP who conducted

the exercise intervention also collected the data, and may have contributed to assessor

bias, potentially favouring exercise benefit. However, objectively evaluated outcomes

were assessed using standard procedures and baseline scores were concealed from



participants during the 12-week follow-up assessment. Further, the results reported

from SAFE reflect unadjusted findings. Consequently, it is possible that the findings

were influenced by characteristics such as marital status, income and education. Also,

physical activity levels lacked objective assessment, and over-reporting at baseline and

12-week follow-up is possible. That is, it is possible that recall bias or social

desirability bias may have influenced self-reporting of physical activity and resulted

in an over-reporting of physical activity (both at baseline and follow-up). However,

the self-report questionnaire used in this study did not specifically include questions

regarding resistance exercise, which may have led to an underreporting of total

physical activity, in particular at the 12-week follow-up assessment. Finally, the

intervention was implemented over a 12-week period. A longer-term RCT with follow-

up is needed to substantiate the longer-term impact of this intervention.

2.11 STRENGTHS

Although mean age of the sample recruited was slightly younger than mean age

of the wider breast cancer population, a key strength of this trial includes the

recruitment of women with stage II+ disease who were insufficiently active at baseline

and were dealing with one or more comorbidities (other than breast cancer) and

persistent breast cancer treatment-related side effects. Further, this study assessed a

pragmatic exercise intervention that reflects the levels of AEP supervision that is

currently available under Medicare, and was in accordance with current

recommendations for individuals with cancer [5, 9, 10], thus increasing the external

validity of the findings. Finally, the study comprehensively evaluated safety as the

primary outcome, in addition to feasibility and potential effect of exercise on important

survivorship outcomes associated with breast cancer and its treatment.

2.12 CLINICAL IMPLICATIONS

Participation in exercise and physical activity is promoted as being safe, despite

a lack of generalisability of research findings to the wider breast cancer population.

The adverse events (rate and type) identified in SAFE demonstrate that exercise is safe

for previously physically inactive women with stage II+ breast cancer who have

multiple comorbidities and treatment-related side effects. Overall, the exercise

prescription in SAFE considered participants’ characteristics, exercise tolerance and

capacity, treatments and presence of treatment-related symptoms, lifestyle (i.e. work

105

or family commitments) and personal preferences. During the first session,

information on medical history, previous exercise habits, current lifestyle and potential

barriers was obtained, and then used to inform the exercise prescription. Subsequent

sessions involved close monitoring and reviewing of participants’ logbooks and

education in exercise safety.

In order to inform the exercise prescription and optimise safety, AEPs should

ensure that important exercise-, disease- and treatment-related information is regularly

documented and obtained from participants. However, SAFE demonstrates that

individualised exercise prescription can be implemented alongside behaviour change

counselling and education with respect to exercise intensity and correct exercise

technique. Participants were provided with safety guidelines for unsupervised home-

based exercise, all of which may have reduced the occurrence of adverse events during

the intervention. Therefore, the findings from SAFE should be evaluated in that

context.

Also, it is important to note that there were a number of exercise and non-

exercise-related adverse events that occurred during the intervention. Therefore,

caution and care with exercise prescription remains relevant in this population. This

highlights the need for regular monitoring and the need for more research to evaluate

effective ways to monitor exercise safety during unsupervised home-based exercise in

this population.

The most recent recommendations from the Clinical Oncology Society of

Australia (COSA) for individuals with cancer states that women should meet the target

of 150 minutes of moderate intensity aerobic exercise, plus at least two resistance

exercise sessions per week [9]. However, the research that underpins these

recommendations has come from studying cohorts of individuals with cancer who are

healthier, in particular women with early-stage breast cancer who have a history of

physical activity and a low disease burden. The present findings highlighted that only

37% of participants in SAFE met the intervention target during every week of the

intervention. The SAFE target for total exercise dose was lower than the most recent

physical activity guidelines for individuals with cancer [9]. In fact, no participant was

able to meet the intervention target during all 12 weeks of the intervention. This

highlights the care that is required to promote physical activity for all people with

cancer. Specifically, helping patients understand and find an appropriate starting point,



promoting generally doing more activity, progressing towards guidelines when

appropriate, and emphasising that doing something is better than nothing, may be more

important than promoting any specific physical activity target. This may be

particularly relevant for inactive women with high disease stage and a high disease

burden.

The findings from this present research highlights the importance of an

individualised approach and encouraging some physical activity (compared with

performing none) with a low and achievable starting point and gradual progression.

Nonetheless, more research is required to determine whether a specific number of

sessions with an exercise professional is sufficient for most women with breast cancer.

Until such time, the findings from this work suggest that the current Medicare-

rebatable model may provide a good foundation for benefit and highlights that an

individualised approach to scheduling of sessions is advocated.

The tools that were developed and implemented as part of the intervention (i.e.

CMF and participant logbooks) form useful resources that may aid in clinical practice,

both in guiding systematic prescription of exercise and reporting of exercise treatment,

as well as thorough and accurate reporting of exercise undertaken during supervised

and unsupervised exercise sessions. It allows for the collection of necessary

information (both by the patient as well as an AEP) to comprehensively and

continuously monitor exercise prescription and exercise completed, and modify when

and how – all of which may contribute to optimising exercise safety, feasibility, effect

and self-efficacy. The next steps for future research would also be to conduct an

adequately powered RCT that evaluates the effect of the current reimbursable model

(five sessions with an AEP) on key patient outcomes including survival, quality of life

and cost-effectiveness.

2.13 SUMMARY

Overall, the safety findings from the present work indicate that an individualised

exercise prescription with behaviour change advice and support, delivered according

to the current rebatable Medicare system is safe for previously physically inactive

women with stage II+ disease who have multiple comorbidities and treatment-related

side effects. Importantly, the findings also suggest that national physical activity

targets for women with stage II+ disease may not be feasible for all women and may

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not be necessary to achieve clinically relevant benefit. Further, five AEP sessions are

associated with clinically relevant benefits in quality of life, aerobic fitness, strength

and physical activity for over 57% of women and, as such, while limited, it serves as

a base from which AEPs can assist improvements in breast cancer survivorship.

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Chapter 3: The effect of a physical activity

counselling session plus a Fitbit

versus physical activity

counselling alone on physical

activity maintenance (Study 2,

the SAFE-Maintain study)

3.1 CHAPTER OVERVIEW

This chapter consists of a literature review of physical activity maintenance and

consumer-based physical activity trackers. This is followed by the purpose, methods,

results and discussion of the SAFE-Maintain trial (Study 2), which evaluated the effect

of a physical activity counselling session plus a physical activity tracker (i.e. a Fitbit)

versus physical activity counselling alone on physical activity maintenance.

3.2 LITERATURE REVIEW

3.2.1 Introduction

Physical activity maintenance has previously been defined as maintaining

physical activity participation for three months or more [107]. The extent to which

physical activity participation is maintained over the longer term is important for the

quality of life and survival of women with breast cancer [192]. Specifically, among

women with breast cancer, findings from a recent meta-analysis [90] reported that

higher physical activity post-diagnosis was associated with a reduction in breast cancer

deaths by 34% (HR=0.66, [95% CI=0.57, 0.77], p<0.01), a reduction in all-cause

mortality by 41% (HR=0.59, [95% CI=0.53, 0.65], p<0.01), and a reduction in disease

recurrence by 24% (HR=0.76, [95% CI=0.66, 0.87], p<0.01). Therefore,

understanding ways in which physically active women can maintain longer-term

physical activity is important to their health and quality of life, and also represents an

important area of translational science [193, 194].

Fifty-six (n=56) women completed the SAFE trial (of note, n=26 completed the

component of SAFE that was the specific focus of Study 1 of this PhD thesis in Chapter

2). The exercise intervention that was delivered in the SAFE study was an

110 Chapter 3: The effect of a physical activity counselling session plus a Fitbit versus physical activity

counselling alone on physical activity maintenance (Study 2, the SAFE-Maintain study)

individualised, 12-week exercise program which set weekly exercise targets consistent

with physical activity guidelines promoted to women with breast cancer [5, 9, 10].

These internationally consistent physical activity guidelines have been based on: 1)

physical activity recommendations for the healthy adult population [112, 195]; 2)

weekly exercise targets used in previous RCTs involving women with breast cancer

that have shown benefit in health outcomes [83, 100]; and 3) observational studies that

indicate that approximately 150+ minutes of moderate intensity physical activity each

week during and following treatment for breast cancer has been associated with

improved disease and survival outcomes [90, 92, 168]. After completing SAFE,

participants showed a significant increase in quality of life and self-reported physical

activity, with 71% of the sample classified as meeting physical activity levels

consistent with national guidelines at study end. Consequently, SAFE participants

represented an ideal sample from which to evaluate strategies to help women stay

active in the longer term.

3.2.2 Behaviour change techniques

A behaviour change technique is defined as ‘an observable, replicable, and

irreducible component of an intervention designed to alter or redirect causal processes

that regulate behaviour’ [196]. Guidelines from the National Institute for Health and

Care Excellence [197] recommended that interventions aimed at improving health

behaviours, such as physical activity, should implement theory-based behaviour

change techniques such as goal-setting, self-monitoring, and social support. Behaviour

change techniques that have been identified in systematic reviews as important for

supporting behaviour change in cancer survivors include: 1) self-monitoring; 2)

individualised information; 3) education; 4) self-management; 5) feedback; 6)

individualised exercise programming; and 7) communication with health professionals

and peer support [198, 199].

Among women with breast cancer, physical activity interventions involving

extensive implementation of behaviour change techniques (such as those listed above

[200]) have shown larger overall effects in increasing physical activity compared with

trials involving sparse and moderate use of behaviour change techniques (effect size =

0.76 versus 0.28 and 0.36, respectively) [200]. Specifically, in relation to maintenance

of health-related behaviours among women with breast cancer, findings from a recent

systematic review [107] found that successful maintenance of outcomes was achieved

111

in trials that implemented a median of five of the following behaviour change

techniques: 1) goal-setting and planning, 2) delivery of information on health benefits

of physical activity (and negative health consequences of physical inactivity), 3)

setting graded tasks, 4) review of behavioural goals, 5) instruction, 6) self-monitoring,

7) feedback on performance, 8) use of follow-up prompts, 9) social comparison, 10)

relapse prevention, 11) motivational interviewing and 12) reinforcing effort or

progress towards the behaviour. Findings from other studies also indicate that

recommendation by an oncologist to be physically active [201], reminders to exercise

[202] and use of a physical activity tracker to quantify and self-monitor physical

activity [202, 203] represent effective behaviour change techniques to support physical

activity maintenance among women with breast cancer.

The three behaviour change theories that have most commonly been used as

frameworks to evaluate physical activity behaviour among women with breast cancer

include the Social Cognitive Theory (SCT), the Transtheoretical Model (TTM) and the

Theory of Planned Behaviour (TPB).

3.2.3 The Social Cognitive Theory (SCT)

The SCT is a model based on interactions between behavioural, personal and

environmental factors [204] (Figure 3.1). Self-efficacy is an individual’s confidence

in their ability to perform a certain behaviour and is the main construct of the SCT

[204]. Based on the theory, if an individual feels confident that they can successfully

undertake a certain behaviour (e.g. overcome barriers), they are more likely to engage

in that activity, and programs that enhance self-efficacy will increase behaviour

compliance [204]. To add to self-efficacy, behaviour is also influenced by: 1) outcome

expectations (which are defined as the expected results that will occur by performing

a behaviour); 2) knowledge of the health risks and benefits of the behaviour; 3) goals

that individuals set for themselves and their plans for achieving goals; and 4) perceived

facilitators and impediments to making behaviour changes, which can be behavioural,

personal and environmental factors [204-206]. Further, evidence is lacking

regarding what specific outcome expectations may be particularly important for

women with breast cancer, especially during different phases of cancer survivorship

(e.g. whether outcome expectations differ between the treatment phase compared with

the post-treatment phase [207]). Of note, outcomes considered most important to

women with breast cancer, likely change throughout the cancer survivorship period.



For example, during treatment, a woman may be driven by maintaining fitness,

whereas post-intervention, her goal may be to improve fitness. For interventions to be

evidence-based, further research is needed to explore what specifically should be

addressed within each construct [207, 208]. Nonetheless, the SCT has been used as a

framework for the conduct of physical activity interventions among breast cancer

survivors and has been demonstrated to be effective for increasing physical activity

[207, 209-212]. Specifically, in a systematic review and meta-analysis of SCT-based

interventions for cancer survivors (n = 12 trials), SCT-based interventions were

effective at promoting physical activity behaviour change, with an effect size of 0.33

[213].

Figure 3.1 Social Cognitive Theory and physical activity behaviour. Adapted from

"Health Promotion by Social Cognitive Means", by S. Bandura, 2004, Health

Education & Behavior, 3 (12), p.143. Copyright 2004 by SAGE

Publications Inc. [206].

3.2.4 Transtheoretical Model (TTM)

The TTM provides a framework for evaluating an individual’s readiness to

change a behaviour, and is also used to provide strategies to guide behaviour change

through stages of motivational readiness [214-216]. The model proposes that physical

activity behaviour change is a dynamic process in which individuals progress or

relapse between five stages [215, 216]: 1) pre-contemplation (individuals in this stage

have no intention to take action in the foreseeable future, usually measured as the

113

following six months); 2) contemplation (in this stage, individuals are not physically

active but intend to change in the next six months); 3) preparation (individuals now

intend to take action in the immediate future); 4) action (the stage in which individuals

have made specific changes in their lifestyles and have been regularly physically active

but for less than six months); and 5) maintenance (in which individuals have made

specific changes in their lifestyles and have been regularly physically active for more

than six months) [195, 215-217]. Key predictors or facilitators of the TTM that lead to

progress through these stages include processes of change (i.e. cognitive and

behavioural processes), self-efficacy, and decisional balance (weighing of benefits

versus consequences of the behaviour) [218, 219]. As an individual progresses through

the stages, perceived benefits of the behaviour increase, while perceived consequences

of the behaviour decrease [219].

The TTM has been used to evaluate how individuals initiate and maintain

physical activity [217, 219, 220]. However, there is a limited number of studies

specifically involving cancer populations. Pinto et al. [221] found that self-efficacy

levels at baseline predicted adherence to MVPA in a sample of breast cancer survivors

who participated in a home-based program. However, the participants’ perceived

benefits and consequences of physical activity did not predict adherence. Loprinzi et

al. [222] evaluated physical activity maintenance following a supervised exercise

program in a sample of breast cancer survivors (n=69) and found that the TTM

constructs of self-efficacy and behavioural processes of change were associated with

MVPA six months post-intervention. That is, those who had high self-efficacy showed

higher levels of MVPA [222]. Together, the findings from these two RCTs [221, 222]

suggest that self-efficacy and the behavioural processes of change influence post-

intervention maintenance [221, 222].

3.2.5 The Theory of Planned Behaviour (TPB)

The TPB proposes that an individual’s intention (the individual’s level of desire

to exert effort and motivation towards the behaviour) to engage in a behaviour is the

immediate determinant of that behaviour [223-225] (Figure 3.2). Intention is affected

by attitudes, subjective norms and perceived behavioural control, all of which are

interrelated [223-226]. Attitude is the individual’s negative or positive evaluation of

participating in the behaviour and is determined by an individual’s expectation of the

outcome and behavioural beliefs (i.e. the perceived benefits and consequences of the



behaviour) [223, 224]. Subjective norm is the perceived social support or pressures

that the individual may experience towards the behaviour [223, 225]. It is determined

by an individual’s motivation to comply with the behaviour and normative beliefs (i.e.

whether other specific important individuals, such as a spouse or healthcare

professional, believes the individual should adopt the behaviour) [223, 225]. Perceived

behavioural control represents the perceived ease or difficulty of undertaking the

behaviour [223, 225], is determined by an individual’s control beliefs (e.g. resources

and available opportunities for engaging in the behaviour), and is behaviour- and

context-specific [223, 226]. Overall, according to the TPB, an individual will engage

in the behaviour when they have the intention to do so, and they possess the necessary

control over the behaviour. An individual will also have the intention to engage in a

behaviour when they view the behaviour positively, believe that other important

individuals (e.g. health professionals or family members) think they should perform

the behaviour, and perceive their engagement in the behaviour to be under their own

control [223, 225].

Figure 3.2 Theory of Planned Behaviour and its components. Adapted from

"Behavioural reasoning theory: Identifying new linkages underlying intentions and

behavior", by J. Westaby, 2005, Organizational Behavior and Human Decision

Processes, 98 (2), p.97. Copyright 2018 by Elsevier B.V. [227].

The TPB is a widely used and validated theory for predicting and explaining

physical activity behaviour change among cancer survivors [228-230]. Prospective

[228, 231, 232] and retrospective [229, 233] study designs have used the TPB to

Behavioural

beliefs and

outcome evaluations

Normative

beliefs and motivation to

comply

Control beliefs

and perceived

facilitation

Attitude

towards the

behaviour

Subjective

norm

Perceived

behavioural

control

Intention Behaviour

115

predict and explain physical activity participation, motivation and exercise

determinants among women with breast cancer [225, 228, 229, 234-238]. Overall

findings from this work have demonstrated that intention is an important determinant

of exercise adherence among women with breast cancer [228]. Attitudes, normative

beliefs and perceived behavioural control are also positively associated with intentions

to participate in physical activity [239]. Key findings in relation to the influence of

attitudes, subjective norm and perceived behavioural control on intention (to exercise)

among women with breast cancer are discussed in the following paragraphs.

Attitude: Behavioural beliefs that influence attitude towards exercise (Figure

3.2) among women with breast cancer include ‘to feel better and improve wellbeing’,

‘maintain a normal lifestyle’, ‘cope with the stress of cancer and treatment’, and

‘recover from surgery and treatment’ [229]. Similarly, in a large RCT (n=377) [238],

important behavioural beliefs that mediated intervention effects on exercise intention

were beliefs about ‘living longer’ and ‘reducing the risk of breast cancer recurrence’

[238]. Patients and survivors who acknowledged these beliefs had a more positive

attitude towards exercise, resulting in stronger intentions to exercise, and higher

exercise participation [229]. As such, interventions designed to increase exercise

among women with breast cancer should attempt to incorporate education components

of the benefits of exercise in relation to these beliefs (e.g. exercise can improve

wellbeing, help with stress, help with recovery and reduce recurrence risk) [229].

Subjective norm: An important normative belief (which directly influences the

subjective norm) is perceived support from an oncologist or physician [228, 229].

Breast cancer is a new and unaccustomed experience for those with a primary

diagnosis, leading to fear and uncertainty [229]. This experience, as well as potential

fears and uncertainty around treatment and long-term outcomes, may mean that breast

cancer patients are more likely to rely on the views of significant others (especially

health professionals) when engaging in health-related behaviours [229]. Consequently,

oncologists, physicians or other treating healthcare professionals play an important

role in promoting physical activity among women with breast cancer [228, 229].

Perceived behavioural control: Important control beliefs that mediate the

intervention effects on intentions among women with breast cancer are ‘having no

support’, ‘additional family responsibilities’, and ‘inability to fit exercise into daily

routine’ [238]. Moreover, Courneya et al. [228] reported that the most important



beliefs were being confident in one’s ability to exercise when experiencing barriers

such as having limited time, no one to exercise with, fatigue, and other treatment-

related sides effects. The more that breast cancer survivors felt they could exercise

despite these barriers, the greater their adherence to the exercise program [228].

Consequently, these control beliefs should be key targets in an intervention designed

to promote exercise adherence in breast cancer survivors; these women require support

and education to overcome these barriers to physical activity [228].

3.2.5.1 The TPB and physical activity maintenance among women with breast

cancer

The influence of key TPB constructs on physical activity maintenance among

women with breast cancer has also been evaluated in two studies to date [203, 234].

Courneya et al. [234] reported that compared with breast cancer survivors who did not

maintain exercise at six months following participation in a supervised exercise trial

conducted during chemotherapy, those that did had more positive attitudes toward

physical activity [234]. They also had stronger perceptions of personal control over

exercise participation, and stronger subjective norms towards exercise [234]. Vallance

et al. [203] used the TPB to evaluate predictors of physical activity six months

following the completion of an RCT (n=377), which involved a physical activity

intervention delivered using print materials and a pedometer. Compared with breast

cancer survivors who did not maintain physical activity, those who did maintain

physical activity reported significantly higher (i.e. more positive) attitudes, perceived

behavioural control (self-efficacy), and intentions at post-intervention [203]. Those

who maintained physical activity were also more likely to adopt physical activity

planning and goal-setting compared with those who did not maintain physical activity

[203]. As such, these findings suggest that adding a goal-setting and planning

component to interventions may facilitate longer-term physical activity maintenance.

3.2.5.2 Comparison between models

In a recent systematic review and meta-analysis, the impact of theoretical

frameworks used for informing interventions to promote health behaviour change was

evaluated [240]. Findings from the review showed that effect sizes associated with

interventions based on the TPB were larger (d= 0.36, k = 9, [95% CI=0.15, 0.56]) than

interventions based on the TTM (d= 0.20, k = 12, [95% CI=0.08, 0.33]) and SCT (d=

0.15, k = 12, [95% CI=0.04, 0.25) [240].

117

Similar to the SCT and TTM, the TPB emphasises the importance of strategies

including goal-setting, problem-solving barriers, self-monitoring, and rewarding

oneself for meeting goals [214-216, 223, 224, 226]. Further, attitudes towards the

behaviour (from the TPB) includes all of the individual beliefs of decisional balance

from the TTM (i.e. benefits and consequences of physical activity) [214-216, 223, 224,

226]. Perceived behavioural control from the TPB has similar qualities as self-efficacy

from the SCT and TTM [223-226]. Further, both intention and behaviour constructs

from the TPB reflect the stages of change construct from the TTM. Therefore,

constructs from the TPB shares various components with the SCT and TTM that

influence exercise behaviour change [214-216, 223, 224, 226].

Overall, the TPB is a relevant and useful theoretical framework for

understanding physical activity maintenance among women with breast cancer [241-

243]. In summary, intention is an important predictor of exercise adherence (i.e. those

who intend to exercise and be physically active, and intend to complete all prescribed

exercise, do so) [228]. In turn, attitudes, subjective norms, and perceived behavioural

control are significant determinants of intentions in this population [244]. Therefore,

these constructs play an important role in exercise participation. Information about

attitudes, subjective norms, and perceived behavioural control in relation to exercise

should be obtained and addressed as part of interventions designed to maintain

physical activity among women with breast cancer [244].

3.2.5.3 Use of behaviour change models in the development of SAFE

The SAFE trial (Chapter 2) was a pragmatic exercise trial that involved

integration of behaviour change techniques. Behaviour change counselling was

delivered by the AEP during supervised exercise sessions as a component of the

intervention. This counselling involved exercise education and discussion around the

following session components and their purpose: exercise intensity, type and total dose

across the week; consequences of physical inactivity and potential benefits of physical

activity; having a targeted, individualised exercise program; goal-setting; self-

monitoring; planning; motivation; and identifying and problem-solving barriers.

Behaviour change strategies designed to promote longer-term physical activity were

also implemented throughout the intervention during supervised sessions. However,

in the absence of ongoing supervision, alternative modes of intervention support may

be needed to maintain physical activity in this sample. Prior work has demonstrated



that print materials about physical activity based on the TPB and pedometers can be

used to effectively deliver physical activity behaviour change techniques and increase

physical activity among women with breast cancer [230, 245-247]. Pedometers and

consumer-based physical activity trackers represent a potential strategy to facilitate

physical activity maintenance in the absence of supervision [248, 249]. In a recent

review of 13 of the most popular consumer-based physical activity trackers, the

authors reported six behaviour change techniques were used in the majority (76%) of

the devices which included: goal-setting, self-monitoring, review of goals, identifying

differences between current physical activity and physical activity goals, feedback,

and environmental factors [249]. As such, the behaviour change techniques that are

used in pedometers and physical activity trackers are consistent with behaviour change

techniques that have been shown to be important for supporting physical activity in

cancer survivors [198, 199, 249].

3.2.5.4 Pedometers

Pedometers are a low-cost, simple, easy-to-use device that can objectively and

accurately monitor physical activity (i.e. number of steps). Pedometers have

previously been included as part of interventions designed to increase physical activity

in healthy adult and breast cancer populations [154, 210, 246, 248, 250]. The real-time

visual feedback from the pedometer immediately increases awareness of physical

activity, which allows self-monitoring and self-management of activity levels [246,

248]. This in turn can act as a form of motivation to facilitate physical activity

behaviour change [210, 248, 251-256].

3.2.5.4.1 Pedometers to facilitate self-monitoring and goal-setting

RCTs that have evaluated the effects of pedometer use in increasing physical

activity have shown mixed results. In a sample (n=50) of predominantly physically

inactive (n=31, 62%) women with stage II+ disease (n=36, 72% with stage II+

disease), a 12-week walking program that involved an intervention booklet including

guidance, which also involved a pedometer to measure and monitor steps, was more

effective for increasing physical activity during chemotherapy compared with usual

care (p<0.03) [257]. In contrast, findings from another RCT (n=95) showed no

difference between a group given a pedometer (n=49) compared to a group given a

standard physical activity recommendation (n=46) for increasing physical activity

during chemotherapy (mean difference in minutes per week of MVPA: –4; 95% CI=

119

–62, 570; p=0.90)[247]). The first trial [257] included the pedometer as one component

of a walking intervention, whereas the second trial [247]) compared the effect of two

different interventions (one involving a pedometer), with both interventions expected

to lead to benefit. Consequently, neither of the trial designs allows for a clear

understanding of the potential benefit to be gained from the use of a pedometer.

Two RCTs (n=86 [221] and n=377 [245]) have evaluated the effect of

pedometer-based interventions on physical activity maintenance among women with

breast cancer. Both trials involved a six-month follow-up assessment of a 12-week

intervention. In one trial [245], women were initially randomised to one of four groups:

1) a standard physical activity recommendation, 2) breast cancer-specific physical

activity print materials, 3) a pedometer only, or 4) a pedometer plus physical activity

print materials. At the six-month follow-up, all four groups showed reductions in

physical activity levels (declines ranged between 23 to 37 minutes per week),

suggesting that inclusion of a pedometer during the initial phases of an intervention

was not superior to the other interventions with respect to physical activity

maintenance in the longer term [245]. In the other trial [221], women were initially

randomised into either usual care or a 12-week home-based exercise program

involving the use of a pedometer. Physical activity declined to a smaller extent in the

intervention group than in the control group at the six-month follow-up. However, the

differences in the declines observed (20 minutes per week) were not statistically

supported, and the clinical relevance in the difference is questionable. Findings from

both trials failed to see the benefit of longer-term physical activity maintenance

through the use of the pedometer. However, it is plausible that differences in timing of

use (e.g. integration of pedometer as the level of supervision or the initial intervention

reductions) may influence findings. Overall, pedometer-based interventions have

shown to be effective for increasing physical activity, but evidence to support their

effectiveness in supporting longer-term maintenance is lacking.

3.2.5.5 Consumer-based physical activity trackers

Consumer-based physical activity trackers are ‘wearable devices that objectively

measure lifestyle physical activity and can provide feedback, beyond the display of

basic activity information (i.e. steps), via the monitor display or through a partnering

application to elicit continual self-monitoring of physical activity behavior’ [258].

Over the past 10 years, the popularity of these devices has grown exponentially into a



$330+ million (US) industry [259], with one in five adult consumers in Australia

owning a physical activity tracker [260]. Similar to the benefits of pedometers, these

devices are highly accessible to consumers (with many of the devices ranging from

$60 to $120), and they produce simplistic output (i.e. total number of steps) which is

immediately understandable to consumers [248]. The devices typically can also

measure physical activity-related indicators such as heart rate, with the ability to

synchronise a website or mobile application to provide more detailed feedback tools

(e.g. physical activity graphs and indicators of progression) [249]. This allows users

to self-monitor and engage with their physical activity data; for example, by setting

physical activity goals and viewing summary graphs of physical activity over time

[252]. Feasibility studies that have evaluated physical activity trackers among healthy

adult populations provide evidence indicating that they are easy to use, can be worn

without discomfort or inconvenience (e.g. wrist-worn like a watch), and are compatible

with most activities of daily living [261, 262]. However, the feasibility and

effectiveness of the devices require further evaluation among clinical populations

including women with breast cancer.

3.2.5.6 Consumer-based physical activity trackers and behavior change

techniques

One particular brand of consumer-based activity tracker is the Fitbit®

(https://www.fitbit.com/au/products). Fitbits accounted for 70% of the approximately

3.3 million consumer-based physical activity trackers that were sold worldwide in

2014 (other brands include Nike and Garmin) [263]. They are currently the most

popular consumer-based physical activity tracker in the market (they were the number

one selling consumer-based physical activity tracker in 2015, with 4.5 million devices

sold worldwide in the second quarter [264]). Although Fitbits are widely utilised in the

consumer market, research efforts have only just begun to evaluate their feasibility and

effectiveness in the cancer setting.

3.2.5.7 Feasibility and effectiveness of Fitbits

To date, the feasibility, acceptability and effectiveness of Fitbits among cancer

populations has been evaluated in six studies involving men with prostate cancer [265]

women with endometrial [266], ovarian [163] and breast cancer [267], mixed cancer

survivors [268], and young adult survivors of childhood cancer [269].

121

3.2.5.7.1 Feasibility

In samples involving men with prostate cancer (n=26, [265]), women with

endometrial cancer (n=25, [266]), and survivors of childhood cancer (n=60) [269],

Fitbits were found to be comfortable to wear and easy to use. Findings have also shown

high levels of use, with participants wearing the Fitbit >72% of the time [266, 269].

Other feasibility findings have shown high satisfaction and positive experiences with

the Fitbits across cancer cohorts, with self-reporting data indicating that participants

had favourable perceptions of the design, affordability, ease of use, and the ability to

set their own physical activity goals [163, 265, 266, 268, 269]. Specifically, self-

monitoring and increased awareness of physical activity levels when using the Fitbit

was highlighted by participants as a motivating factor for increasing their activity [163,

265, 266, 268, 269]. Technology difficulties (such as difficulties using the App and

synchronising, downloading their data, low battery or forgetting to charge the device)

were identified as barriers to use, but were considered minor by participants [265].

Further, potential limitations highlighted in one study included a high malfunction rate

(n=5 devices had to be replaced due to malfunction) and loss of devices (n=3

participants lost their Fitbit) [163].

The Fitbit has also been evaluated among cancer populations for its ability to

increase physical activity in three studies [163, 267, 269], while there has been one

study that has specifically evaluated physical activity maintenance [268]. First, in an

RCT involving women with breast cancer (n=87), a Fitbit plus physical activity

behaviour counselling over 12 weeks was more effective for increasing MVPA and

total activity compared with usual care (mean increase: 20.7 vs. 14.2 minutes per day,

b=7.24, p<0.01; and mean increase: 27.4 vs. 4.9 minutes per day, b=10.05, p<0.02,

respectively) [267]. Second, findings from an RCT involving 14- to 18-year-old cancer

survivors evaluating the effect of a 10-week Fitbit-based intervention (n=60) showed

no effects on physical activity levels despite increases in motivation to exercise

(p<0.05) [269]. Third, findings from a single group, pre-post 26-week trial involving

women with ovarian cancer (n=10) suggested that a Fitbit-based intervention was

associated with an increase of 1,600 steps per day and 15 minutes of physical activity

per day [163]. Finally, in another single group pre-post study that was specifically

designed to evaluate physical activity maintenance, physical activity was maintained

over a 4-week period following completion of a supervised exercise intervention in a



sample of mixed cancer types (breast cancer: n=14 [58.3%]) [268]. However,

limitations of this body of research include small samples sizes (only one study had a

sample size greater than 60), the limited number of trials specifically evaluating

women with breast cancer (only one study specifically evaluated women with breast

cancer), and the limited number of RCTs (n=2). Further, physical activity was not a

primary outcome in the two RCTs noted. Importantly, due to the design of these

previous studies, the findings do not provide clear evidence to suggest benefit with the

addition of a Fitbit, in particular the inclusion of a Fitbit after other intervention

components designed to increase physical activity (e.g. supervision) have stopped (i.e.

does the timing of when to implement a Fitbit matter?).

In summary, consumer-based physical activity trackers show promise in helping

women with breast cancer maintain physical activity levels in the longer term as they

encourage theory-based physical activity behaviour change strategies [249, 258] such

as self-awareness, self-monitoring and individualised feedback as part of their use

[270-273]. There are also consistent findings showing that Fitbits are considered

acceptable and feasible in various cancer cohorts, including women with breast cancer.

However, although these devices have the potential to be integrated into physical

activity interventions that are designed to promote longer-term maintenance [249],

their effectiveness for increasing or maintaining physical activity levels in the breast

cancer setting needs further investigation.

3.2.6 Physical activity following breast cancer

As discussed in Section 1.6, prospective population-based data indicates that

physical activity levels decline among women following diagnosis [74-76]. The

proportion of women who are physically active (meeting the national physical activity

guidelines) reduces between pre-diagnosis and six months post-diagnosis from 60% to

35%, and the proportion of those who are inactive increases from 16% to 42% in the

absence of intervention [76].

Previous systematic reviews and meta-analyses have reported that participating

in exercise and physical activity interventions following a breast cancer diagnosis

leads to significant increases in physical activity levels (d=0.38 [95% CI=0.22, 0.54],

p<0.01, n=16 RCTs [83] and d=0.47 [95% CI=0.23, 0.67], p<0.01, n=14 RCTs [108]).

Further, findings from intervention studies conducted post-diagnosis have shown that

exercise during and following treatment leads to improvements in physical function,

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aerobic fitness, muscle strength, body weight, body fat, self-esteem, mood, depression,

anxiety, quality of life, breast cancer-specific concerns, self-perception, body image,

fatigue, and treatment-related symptoms and side effects (all p<0.01, WMES range =

0.14 to 0.99) [83, 87]. However, there has been a limited number of trials that have

evaluated post-intervention physical activity maintenance among women with breast

cancer. Findings from a recent systematic review showed that only 16% (n=10) of

physical activity and dietary behaviour change interventions involving breast cancer

survivors evaluated and reported on maintenance of outcomes (i.e. at least three

months post-intervention) [107]. Less than half of these trials (40%) achieved

successful maintenance (defined as no significant reduction in physical activity

between post-intervention and follow-up) [107].

3.2.6.1 Post-intervention physical activity maintenance among women with

breast cancer

Findings from three RCTs (n=69 to 242) have reported that 42 to 79% of

participants did not remain physically active approximately six months following

completion of an exercise intervention [173, 222, 274]. Three other RCTs (n=86 to

377) reported reductions in physical activity of between 37 and 90 minutes per week

at six months post-intervention [188, 221, 245]. The degree to which behaviour change

strategies were integrated in the interventions preceding the follow-up periods varied.

Four [173, 188, 221, 245] of the six RCTs specifically reported use of various

behaviour change techniques, which included physical activity counselling that

focused on the benefits of exercise, enhancing self-efficacy, self-monitoring, goal-

setting and problem-solving and overcoming barriers. One of the six studies [188]

specifically reported that the model of behaviour change used in the intervention was

designed to promote post-intervention maintenance [173]. Two of the six RCTs [221,

245] included the use of a pedometer during the intervention period, with pedometer

use continuing during the follow-up period at participant discretion. Overall, of the six

trials, the interventions that preceded the follow-up periods that were highly supervised

involved little-to-no implementation of behaviour change techniques or strategies to

support post-intervention maintenance during the follow-up period. In contrast, trials

that did implement strategies to support post-intervention maintenance (including the

use of pedometers and follow-up behaviour change support) were not preceded by a

supervised intervention involving behaviour change education to promote longer-term



maintenance. Therefore, a combined approach (i.e. a supervised exercise intervention

involving behaviour change education around post-intervention maintenance followed

by implementation of additional strategies to support longer-term maintenance (e.g.

pedometers and behaviour change counselling) may represent an ideal approach,

although this requires empirical evaluation in this population.

Cancer survivors self-report a willingness to use technology-based interventions

to support physical activity [275]. In a recent evaluation of breast cancer survivors’

preferences for technology-supported exercise interventions (n=279; mean age= 60.7,

SD= 9.7), almost half reported owning a physical activity tracker (41%), most were

interested in receiving distance-based exercise counselling (85%), and participating in

a non-face-to-face delivered exercise intervention (80%) [276]. Therefore, physical

activity consumer devices may have potential to support longer-term physical activity

in women with breast cancer.

3.2.7 Summary of key points

Most (>70%) physical activity and exercise interventions targeting women with

breast cancer do not evaluate post-intervention maintenance [107]. Among trials that

do evaluate post-intervention outcomes, women with breast cancer show declines in

physical activity in the absence of ongoing supervision (as discussed in Section

3.2.6.1) [107]. Reduced adherence to physical activity post-intervention is associated

with the deterioration of the benefits obtained during the intervention, and loss of

potential ongoing and longer-term benefits [277]. Therefore, maintaining exercise

participation and the benefits achieved during an intervention is important for the long-

term health and survival of breast cancer survivors. Evaluating effective approaches to

maintain physical activity therefore requires research attention.

The use of consumer-based physical activity trackers is considered acceptable

and feasible [245, 247, 265, 268, 278, 279]. However, their effectiveness for increasing

or maintaining physical activity in the general adult population and various clinical

populations including mixed-cancer and breast cancer populations remains unclear.

Fitbits incorporate various features that promote physical activity behaviour change

techniques, such as goal-setting and self-monitoring, that may assist with longer-term

physical activity maintenance [252, 280]. Accordingly, the objective of the second

study related to this PhD, ‘SAFE-Maintain’, was to evaluate the effect of the use of a

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physical activity tracker (specifically a Fitbit) on physical activity maintenance among

active women with stage II+ breast cancer.

3.3 BACKGROUND TO STUDY 2

The SAFE trial involved integration of behaviour change strategies as part of the

intervention in order to promote longer-term physical activity maintenance (described

in Section 2.5.4.8 and 2.5.4.9). The intervention was effective for increasing physical

activity participation among the sample of previously inactive women with stage II+

breast cancer. As such, this work provided the ideal platform from which to evaluate

the potential role of a physical activity tracker (i.e. a Fitbit) in physical activity

maintenance.

3.4 STUDY OVERVIEW, DESIGN AND AIM

The SAFE-Maintain trial sought to evaluate the effect of a physical activity

counselling session with or without the provision of a physical activity tracker (i.e. a

Fitbit) on physical activity maintenance in participants who completed the SAFE trial.

The trial was a 12-week RCT, with random allocation to a physical activity counselling

session with an AEP and physical activity booklet at baseline (PAC group) or a

physical activity counselling session, a physical activity booklet, plus a physical

activity tracker (a Fitbit) to wear and use for 12 weeks (PAC+F group).

3.5 ETHICAL APPROVAL AND INFORMED CONSENT

Prior to commencing enrolment and data collection, ethical approval for this trial

was sought and obtained from the Human Research Ethics Committee (HREC) at the

Queensland University of Technology (approval number: HREC 16000 00631). All

participants provided written informed consent prior to participation in the trial.

3.6 HYPOTHESIS

It was hypothesised that the PAC+F group would have higher physical activity

levels at the 12-week follow-up compared to the PAC group.

• Null hypothesis: physical activity levels at the 12-week follow-up would be

the same for those randomised to the PAC+F group compared with the PAC

group.



• Alternative hypothesis: the PAC+F group would have higher physical

activity levels at the 12-week follow-up compared with the PAC group.

3.7 SECONDARY OBJECTIVES

The secondary objectives were to compare self-reported quality of life, upper-

extremity function and exercise self-efficacy at the 12-week follow-up between the

PAC+F and PAC groups.

The hypotheses for quality of life (and related outcomes), upper-extremity

function and exercise self-efficacy were:

• Null hypothesis: quality of life (and related outcomes), upper-extremity

function and exercise self-efficacy at the 12-week follow-up would be the

same for those randomised to the PAC+F group as those in the PAC group.

• Alternative hypothesis: those in the PAC+F group would have higher

quality of life (and related outcomes), upper-extremity function and exercise

self-efficacy at the 12-week follow-up compared with those in the PAC

group.

3.8 EXPLORATORY OBJECTIVE

As an exploratory objective, this study also evaluated the feasibility and

acceptability of the use of a Fitbit. Feasibility and acceptability of the Fitbit included

evaluation of participants’ perceptions and usage of the device through a participant-

administered questionnaire at the 12-week follow-up.

Feasibility and acceptability criteria were developed a priori using feasibility

criteria from previous studies that have evaluated Fitbits among individuals with

chronic disease [281] or physical activity trackers among women with breast cancer

[159, 282]. The cut-off value of 80% (below) was established based on previous

studies [159, 281, 282]. These criteria included:

3.8.1 Feasibility

The Fitbit was considered feasible if all of the following are met:

a) participants wore the Fitbit for 10 or more hours a day on at least five out of

seven days in an average week (based on group mean);

b) >80% of participants found the Fitbit easy to use;

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c) >80% of participants found the Fitbit comfortable to wear;

d) >80% of participants were satisfied with the Fitbit as a means of supporting

physical activity maintenance;

e) >80% participants would continue to use the Fitbit in future.

3.8.2 Acceptability

Acceptability of the Fitbit was assessed by evaluating use of the device, as well

as likes, dislikes and barriers experienced by the participants, as recorded through a

participant-administered questionnaire at the 12-week follow-up.

3.9 METHODS

3.9.1 Setting

The baseline data collection and physical activity counselling sessions were

conducted at the Institute of Health and Biomedical Innovation exercise testing rooms

(Brisbane, Queensland University of Technology) during an in-person visit by

participants. Following completion of the physical activity counselling sessions, there

was no contact between the study researcher and participants during the 12-week

follow-up period.

3.9.2 Inclusion criteria

Eligible participants were those who completed SAFE (Chapter 2). Therefore,

inclusion criteria were the same as SAFE (Section 2.5.4.1). Not all participants were

meeting the national physical activity levels recommended by national guidelines at

time of completion of SAFE. Nevertheless, recruiting SAFE participants into this trial

provided an appropriate physical activity baseline from which to evaluate physical

activity maintenance (i.e. all participants were either meeting national physical activity

guidelines all of the time or some of the time in the preceding 12 weeks, or were

progressing towards meeting the national physical activity guidelines over time).

3.9.3 Exclusion criteria

Participants were ineligible if at the time of recruitment into SAFE-Maintain,

they were: planning to become pregnant during the study; had plans for additional

surgery (e.g. reconstructive) during the study period; were planning on travelling or

being away for the intervention period; unable to provide informed consent; or had



been diagnosed with disease recurrence or a newly diagnosed medical condition that

would prohibit participation in home-based, unsupervised exercise (e.g. unstable

hypertension).

3.9.4 Recruitment

Within the final two weeks of SAFE, all participants were informed about SAFE-

Maintain and were provided a study information pack including a letter outlining the

study, a consent form and a refusal of consent form that could be returned to the project

coordinator. Immediately following final data collection for SAFE, participants who

expressed interest in participating in SAFE-Maintain remained on-site and had the

study explained to them in more detail. Participants were provided the opportunity to

ask questions and were checked for eligibility status. Following receipt of informed

consent for interested and eligible women, baseline personal, demographic, clinical

and health history information were confirmed. Participants then received a sealed

opaque envelope, with a letter inside informing them of their group allocation.

Participants opened the envelope to reveal whether they would receive a Fitbit for use

over the next 12 weeks or not.

3.9.5 Physical activity counselling session and intervention booklet

Participants in both groups received a face-to-face counselling session and a

physical activity booklet at baseline [283]. The booklet, titled ‘Staying active after

S.A.F.E’ (see Appendix K) was developed as a component of this PhD, with

consultation from two senior exercise physiologists (supervisors S. Hayes and R.

Spence) who have experience in physical activity counselling and booklet

development and implementation among breast cancer survivors [4]. The booklet

presents a modified version of previous physical activity booklets used in breast cancer

trials, including TPB-based interventions [4, 203, 223, 224, 230, 244, 284]. The

booklet was based on achieving the current physical activity and exercise

recommendations for individuals with cancer, which is to engage in 150+ minutes per

week of moderate- or high-intensity exercise, including aerobic- and resistance-based

exercise [10].

Each section of the booklet included written activities to allow participant

engagement in the information and self-paced learning during the 12-week

intervention period. Participants were verbally guided through the booklet content

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during the counselling session and were then provided the booklet to complete during

the 12-week period at a self-selected pace. Participants were advised that the booklet

would not be collected by the study researcher at the end of the 12 weeks. Development

of the booklet and components of the booklet are described below.

3.9.6 Booklet development and components

The TPB constructs of physical activity-related attitudes, subjective norms,

perceived behavioural control and implementation of intentions (e.g. physical activity

planning and goal-setting) were used as the framework of the booklet content. The

booklet content was based on the overarching TPB perspective that women with breast

cancer will intend to maintain physical activity when they perceive it to be under their

own control, they believe longer-term exercise will be enjoyable and beneficial, and

important others will encourage and support their physical activity [223-225]. Sections

relating to goal-setting and planning were also implemented in the booklet to address

belief change and planning strategies (i.e. implementation of intention) [238, 285]. A

detailed overview of these constructs and summary of how they were implemented

into the booklet is included in Appendix L. An overview of the booklet sections and

targeted TPB constructs that each component addressed is included in Appendix M.

3.9.7 Physical activity counselling session (received by PAC and PAC+F groups)

The counselling session was a 60-minute, one-on-one session conducted by the

PhD candidate.The counselling session was semi-structured, with the content of the

booklet used to guide the structure of the session [286]. The AEP engaged with the

participant in a discussion of various strategies for maintaining longer-term physical

activity. Counselling included informing participants on maintaining longer-term

physical activity in the presence of breast cancer side effects or breast cancer-specific

barriers, and how to use self-monitoring and feedback to assist participants to feel

supported and to promote greater adherence [287]. The AEP ensured that physical

activity advice and feedback was individualised, taking into consideration personal

goals and circumstances (e.g. current health status and treatment-related side effects

[287]). Feedback to the participants focussed on their personal behaviour and physical

activity goals and encouraging progression in the exercise over time and sustaining

sufficient levels of physical activity [287]. Participants were also encouraged to



identify barriers to reaching their goals, and to formulate strategies to overcome these

potential barriers.

At the time of completion of SAFE, participants were aware that the

recommended physical activity level for women with breast cancer was to perform at

least 150 minutes per week of moderate intensity aerobic- and resistance-based

exercise [5, 10, 288]. Most participants (77%) were meeting this goal at least some of

the time, and were encouraged to maintain this level for the longer term (i.e. not just

throughout the next 12-week period). For those not meeting national physical activity

recommendations, they were encouraged to continue to progress towards meeting this

weekly goal or meeting this goal more regularly. Overall, all participants were aware

that some physical activity was better than performing none, and that more is generally

better than less, at least up to the 150 minute, moderate-intensity, weekly target. Of

note, none of the content covered during the session was new for these participants, as

all the information had been covered throughout the implementation of SAFE.

Following completion of the counselling session, there was no further scheduled

contact between the AEP/researcher, apart from a telephone call during week 11 to

schedule the 12-week data collection. Exceptions to this included: 1) if a participant

experienced an adverse event; or 2) if a participant experienced technical difficulties

with their Fitbit (for those in the PAC+F group). If a participant experienced an adverse

event during physical activity participation (e.g. a muscle strain during walking),

participants were instructed to seek appropriate first-aid and/or clinical follow-up.

Participants were also advised to contact the project manager by telephone as soon as

possible following the event to ensure accurate recording of relevant details, to

question whether adequate medical attention had been received, and to discuss whether

modifications were required to their physical activity goals.

3.9.8 Provision of a Fitbit (received by PAC+F group only)

Participants who were randomised to the PAC+F group received the 60-minute

counselling session and booklet plus a Fitbit physical activity tracker (Model: Fitbit®

Charge HR: Fitbit Inc., San Francisco, California) for the 12-week follow-up period.

Participants were also provided with the USB cable and Fitbit information brochure

for further information on using the device. The PAC+F participants received basic

instruction on using and setting-up the Fitbit, and brief advice on interpreting data and

using the Fitbit to support physical activity during the session. This included

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instruction on the following: 1) how to use the basic functions of the Fitbit (including

charging the battery); 2) how to interpret basic features (e.g. step counts, heart rate);

3) looking at the data displayed on the Fitbit to self-monitor physical activity (e.g. step

counts); and 4) the supporting smart-device application (e.g. smart phone App) [252].

Participants were provided with the same general intervention goals as the PAC group.

No specific physical activity goals based around the Fitbit were provided, although

minimal advice on how the Fitbit could be used to support goal-setting that was

outlined in the booklet was integrated into the session [252, 289]. Participants were

provided with several basic examples which included checking their heart rate and

number of steps during their exercise sessions (e.g. ‘You may decide to use the Fitbit

to monitor your steps and distance during your morning walk’). Overall, participants

were advised they may use their Fitbit (and its associated website or App) as desired

to self-monitor and manage their physical activity in whatever way that was deemed

useful to them [281, 288, 290].

3.9.9 Data collection and blinding

At baseline and the 12-week follow-up, self-reported outcomes were assessed

with self-administered questionnaires (described below). Due to logistical reasons

(specifically because baseline assessment for SAFE-Maintain coincided with follow-

up assessment for SAFE), objectively-assessed physical activity (using

accelerometery) was assessed at the 12-week follow-up only. Among participants in

the PAC+F group, their experiences of using the Fitbit, or any other wearable physical

activity tracker, was also evaluated through a participant-administered questionnaire

at the 12-week follow-up. Data collection at the 12-week follow-up was conducted

either by mail-out (and reply-paid postage) or in-person drop-off and collection from

participants’ homes. Further, the PhD candidate conducted baseline and 12-week

follow-up assessments, as well as the counselling sessions, and as such, blinding of

assessor or intervention delivery was not possible.

3.9.10 Primary outcome

3.9.10.1 Self-reported physical activity

All physical activity outcomes derived from the Active Australia Survey were

computed in accordance with the instrument’s specific scoring protocols [146, 147].



Self-reported physical activity outcomes derived from the Active Australia Survey

included [146, 147]:

1. Minutes per week of:

a. walking;

b. moderate intensity physical activity;

c. vigorous intensity physical activity;

d. total MVPA (moderate activity + vigorous activity);

e. total activity (walking + moderate activity + vigorous activity).

2. Proportions (n, %) of participants meeting physical activity guidelines of at least

150 minutes per week of total MVPA and total activity at baseline and the 12-week

follow-up.

3. Proportions (n, %) of participants that between baseline and the 12-week follow-

up either:

a. increased their MVPA by >30 minutes per week;

b. increased their total activity by >30 minutes per week;

c. decreased their MVPA and total activity by >30 minutes per week;

d. decreased their total activity by >30 minutes per week;

e. maintained their MVPA (i.e., did not increase or decrease by >30

minutes per week);

f. maintained their total activity (i.e. did not increase or decrease by

>30 minutes per week).

3.9.10.2 Objectively-measured physical activity

The Actigraphs (model: GT3X+ tri-axial accelerometers) were worn in week 12

of SAFE-Maintain. Participants were asked to wear the accelerometer on the hip at all

times during the day and night, excluding sleep and water-based activities, for the

seven-day assessment phaseAfter the seven-day wear period, data were downloaded

using the Actigraph software (ActiLife, version 5.8.3) and screened for completeness

and irregularities [267]. Seven consecutive days of monitoring is recommended for

healthy and clinical populations [267] and has been used in previous studies involving

women with breast cancer [267, 291], with four valid days of data required for the

assessment to be considered adequate for use [291, 292]. A minimum of 10 hours per

day was used as the cut-off for a valid day of measurement [293, 294]. Bouts of ≥ 90

133

minutes of zero counts per minute (allowing for <3 minutes of counts 1 to 49 count

per minute) were excluded as non-wear time [267, 293]. Activity minutes were

analysed per week for consistency with the intervention target of 150 minutes for the

week, but activity counts were analysed per day due to the magnitude of this number

[267, 293]. The accelerometer recorded the maximum activity count in 60 second

epochs, providing data on time spent in light, moderate, and vigorous physical activity,

as well as steps. Standard calibration thresholds were used to aggregate data into

minutes per week of moderate and vigorous activity using the Freedson cut-points

[267, 293, 294]. The cut-points were: sedentary (<100 counts), light (101 to 1,951),

moderate (1,952 to 5,724), or vigorous (>5,725) [267, 293, 294]. All minutes with

≥1,952 count per minute [294] were classified as MVPA and were summed for each

day and averaged across valid days, then multiplied by seven to compute a weekly

value. The average step counts from valid wear days was used to compute steps per

day. Physical activity outcomes derived from the Actigraph accelerometer were:

1. objectively-measured MVPA at 12 weeks (minutes per week);

2. daily steps at 12 weeks (steps per day);

3. proportions (n, %) of participants meeting physical activity guidelines of at least

150 minutes per week of MVPA at 12 weeks.

Of note, all self-reported and objectively-assessed physical activity outcomes

included only minutes that were accumulated in bouts of at least 10 continuous

minutes. This is consistent with the American Heart Association and American

College of Sports Medicine physical activity recommendations for adults [295] and

previous methods used to analyse accelerometer data [296, 297].

3.9.11 Secondary outcomes

Secondary outcomes were quality of life (and related outcomes), upper-

extremity function and exercise self-efficacy, assessed at baseline and the 12-week

follow-up. Quality of life was assessed using the FACT-G [136, 137, 152, 153],

PROMIS Global Short-form and PROMIS-43 scales [138, 139, 141, 154]. Upper-

extremity function was assessed using the PROMIS upper-extremity scale [142] and

self-efficacy was assessed using the barriers self-efficacy scale [143, 144]. These were

the same instruments used to evaluate self-report outcomes in SAFE (please refer to



Section 2.5.4.13 for a full description of these instruments). A five-unit change in total

FACT-G score (and two units in each sub-scale), a nine-unit change in PROMIS total

score (and four units in each subscale), and a seven-unit change in barrier self-efficacy

was considered clinically meaningful [145, 298, 299].

3.9.12 Exploratory outcome: Fitbit feasibility and acceptability

Participant engagement and satisfaction with the Fitbit was assessed using a

questionnaire which included questions relating to frequency of use and features that

participants liked and disliked [149, 300] (see Appendix N for full questionnaire).

Participants were also asked to report any problems experienced with the Fitbit (e.g.

skin irritation, discomfort or technical difficulties). The questions were developed

based on questionnaires used in previous physical activity tracker feasibility and

acceptability studies [159, 265, 266, 289]. To address feasibility, participants’

perceptions and satisfaction were reported as categorical outcomes.

3.9.12.1 Feasibility

Criteria to evaluate the feasibility of the Fitbit were developed based on previous

feasibility studies [159, 265, 266, 289]. The Fitbit was deemed as ‘feasible’ if each of

the following met the pre-defined feasibility criterion:

1. Compliance:

a. Compliance with wearing the Fitbit: The mean (SD) number of days that

participants wore the Fitbit per week and mean number of hours the Fitbit

was worn in a typical day was obtained by self-report at 12 weeks. The Fitbit

was considered feasible if participants wore the Fitbit for at least 10 hours per

day on five out of seven days in an average week [159].

2. Ease of use:

a. Ease of use was determined by: the number of ‘yes’ responses to the question

‘Overall, did you find the Fitbit easy to use during the 12 weeks?’. The Fitbit

was considered feasible if >80% of participants found the Fitbit easy to use.

3. Comfort:

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a. Comfort was determined by: the number of ‘yes’ responses to the question

‘Overall, did you find the Fitbit comfortable to wear during the 12 weeks?’.

The Fitbit was considered feasible if >80% of participants found the Fitbit

comfortable to wear.

4. Satisfaction:

a. Satisfaction was defined by: the number of ‘yes’ responses to the question

‘Overall, were you satisfied with the Fitbit in helping you keep physically

active to wear during the 12 weeks?’. The Fitbit was considered feasible if

>80% of participants were satisfied with the Fitbit as a means of supporting

physical activity maintenance.

5. Future use:

a. Plans for continued use determined by the number of ‘yes’ responses to the

question ‘Overall, would you continue to use a Fitbit in the future?’. The

Fitbit was considered feasible if >80% participants would continue to use a

Fitbit in future.

3.9.12.2 Acceptability

Acceptability was also measured using the self-administered questionnaire at the

end of the 12-week period. This evaluation assessed the following: perceived

effectiveness and usefulness of the Fitbit, use of device features, number of times that

the participants viewed data in their Fitbit device and uploaded and viewed their data

online (obtained via self-report), and likes and dislikes. Qualitative comments were

examined to determine the presence of common themes or differences among

participants [301].

3.9.13 Sample size

Sample size in SAFE-Maintain was limited by the number of participants who

completed SAFE. Power calculations were conducted on physical activity outcomes

using a within-group mean (SD) change over 12 weeks and between-group difference

at 12 weeks based on similar previous studies [246, 302]. Power analyses showed that

26 participants per group would result in 65% power (5% significance, two-sided) to

detect as statistically significant a 30 minute per week (SD=100) difference in self-

report MVPA, a 60-minute per week (SD=80 minutes per week) difference in self-



reported walking and 1,600-step per day (SD=400 steps per day) difference in steps

[246, 247, 303] between groups.

3.9.14 Statistical analysis

Analysis of continuous outcomes: Continuous outcomes were assessed for

normality. These variables were described using mean and 95% confidence intervals

for normally distributed outcomes and medians (minimum, maximum) for non-

normally distributed outcomes. There was no imputation of data and participants

without 12-week outcome data were excluded from analyses. Continuous outcomes

that were assessed at both time points (self-report physical activity, quality of life,

upper-extremity function and exercise self-efficacy) were evaluated using a repeated-

measures 2 (time) × 2 (group) analysis of variance (ANOVA) to test the main effects,

as well as interaction effects to compare the difference in means within-groups

(baseline to the 12-week follow-up) and between-groups (at the 12-week follow-up).

Continuous outcomes that were assessed only at the 12-week follow-up and were not

normally distributed (objectively-measured physical activity) were evaluated using a

non-parametric test (Mann-Whitney test) to compare between-group differences.

Analysis of categorical outcomes: Between-groups comparisons were

undertaken to compare: 1) the proportions of participants meeting physical activity

guidelines at the 12-week follow-up in each group based on self-report and

objectively-assessed MVPA and total activity; and 2) the proportions of participants

that either increased, decreased or maintained their physical activity levels during the

12-week period in each group using Chi-square tests.

Statistical significance was set at 0.05 and all analyses were completed using

SPSS statistical software (Version 22.0, IBM corporation, Somers, NY, USA).

Previous reports were used to determine a clinically relevant change over time in the

primary outcome. For self-report MVPA, 30 minutes per week is considered a

clinically meaningful change [76]. Therefore, maintenance of physical activity

participation was considered as an increase or a reduction of less than 30 minutes per

week between baseline and 12 weeks. As an exploratory analysis, feasibility of the

Fitbit was assessed by computing compliance and acceptability using predefined

criteria (as described in Section 3.9.12).

137

3.9.15 Data management and quality control

During each testing phase, collected questionnaires were assessed for missing

data and additional information was collected where needed and appropriate.

Objective and subjective measures were pre-coded for data entry and key entered

twice. Out-of-range or inconsistent data were checked using SPSS statistical software

and resolved prior to data storage. Names and contact information were kept separate

from other data, which was stored using a unique but otherwise meaningless

identification number. Linkage of data across time and between data sources were

accomplished by this identification number.



3.10 RESULTS

3.10.1 Participant flow

Fifty-four participants completed the SAFE trial and were potentially eligible for

SAFE-Maintain (Figure 3.3). Of these, two refused consent (disease progression, n=1;

commencing new treatment and declined to participate, n=1). A total of 52 consented

and were enrolled in SAFE-Maintain, all of whom provided complete baseline data

(Figure 3.3). Following baseline data collection, participants were randomised to either

the PAC (n=26) or PAC+F (n=26) group. One participant in the PAC group was lost

to follow-up (uncontactable), resulting in no 12-week follow-up data. Objective

assessment of physical activity was not possible for one participant in the PAC+F

group at the 12-week follow-up; however, all self-report outcomes were obtained from

this participant at this time point. There were no adverse events reported during the

12-week period.

139

Figure 3.3 CONSORT participant flow diagram



3.10.2 Participant baseline characteristics

Participant baseline characteristics are shown in Table 3.1. Overall,

randomisation was successful with most personal, medical and lifestyle characteristics

similar between groups at baseline with the exception of employment, private health

cover, smoking history and previous intervention group in SAFE, which had absolute

between-groups differences of greater than 10%. Specifically, higher proportions of

participants in the PAC+F group were employed part-time (39% and 8%), had private

health insurance (85% and 70%), had a smoking history prior to diagnosis (42% and

23%) and had completed the five supervised session SAFE intervention (54% and

43%) compared with the PAC group, respectively. During the study period, four

participants (15%) in the PAC and two participants (8%) in the PAC+F group were

currently undergoing either radiation therapy or chemotherapy.

The proportion of participants meeting physical activity guidelines at baseline

was equal between groups (n=20, 77% per group), with no clinically relevant

difference in self-reported MVPA (mean: 113.6 [SD=101.5] vs. 122.1 [SD=100.9]

minutes per week) and total activity (mean: 271.8 [SD=179.2] vs. 264.8 [SD=178.6]

minutes per week) between the PAC and PAC+F groups, respectively.

141

Table 3.1

Participant baseline characteristics

PAC

N=26

Mean (SD) or

Median (minimum,

maximum)

PAC+F

N=26

Mean (SD) or

Median (minimum,

maximum)

Age (years), mean (SD)

Median (minimum, maximum)

52.8 (9.5)

54 (35, 70)

49.5 (8.6)

49 (32, 67)

Age at diagnosis (years), mean (SD)


48.9 (11.3)

46.5 (25, 68)

47.3 (8)

47.5 (31, 65)

Body mass index (kg/m2) 28.5 (5.2) 28.7 (6)

Body mass index (kg/m2) n (%)

Underweight (<18.5)

Healthy (18.5–24.9)

Overweight (25–29.9)

Obese (>30)

0 (0%)

7 (26.9%)

9 (34.6%)

10 (38.5%)

0 (0%)

9 (34.6%)

7 (26.9%)

10 (38.5%)

Smoking status

Current (yes)

Previously (prior to diagnosis, yes)

0 (0%)

6 (23.1%)

0 (0%)

11 (42.3%)

Standard alcoholics drinks (per week) 0 (1, 6) 0 (0,14)

Marital status

Single

Married, defacto or living together

Divorced/separated

Widowed

2 (7.7%)

17 (65.4%)

6 (23.1%)

1 (3.8%)

4 (15.5%)

18 (69.2%)

3 (11.5%)

1 (3.8%)

Highest level of education

High school (Grade 12 or lower)

Trade, certificate or diploma

Bachelor or Higher Degree

9 (34.6%)

9 (34.6%)

8 (30.8%)

9 (34.6%)

8 (30.8%)

9 (34.6%)

Employment status

Employed– full-time

Employed– part-time

Employed– casual

Other

Retired

7 (26.9%)

2 (7.7%)

1 (3.8%)

11 (42.4%)

5 (19.2%)

4 (15.4%)

10 (38.5%)

0 (0%)

11 (42.3%)

1 (3.8%)

Number of work hours in paid

employment per week

9.2 (12.5)

12.9 (14.5)

Private Health Cover

Yes

22 (84.6%)

18 (69.2%)

Household weekly income (before tax)

$0-$1121

$1122-$2231

>$2232

Missing

10 (38.5%)

7 (26.9%)

5 (19.2%)

4 (15.4%)

9 (34.6%)

12 (46.2%)

3 (11.5%)

2 (7.7%)

Disease stage

II

III

12 (46.2%)

9 (34.6%)

12 (46.2%)

10 (38.4%)



IV

Missing

3 (11.5%)

2 (7.7%)

2 (7.7%)

2 (7.7%)

Since your original breast cancer

diagnosis, has your breast cancer

spread to other areas of your body?

(yes)

5 (19.2%)

3 (11.5%)

Have you previously been diagnosed

with cancer other than breast? (yes)

3 (11.5%)

0 (0%)

Treated side

Left

Right

Both

12 (46.2%)

12 (46.2%)

2 (7.6%)

15 (57.7%)

8 (30.8%)

3 (11.5%)

Treatment status (currently

undergoing)

Chemotherapy

Radiotherapy

3 (11.5%)

1 (3.8%)

1 (3.8%)

1 (3.8%)

Surgery

Mastectomy/MRM

17 (65.4%)

17 (65.4%)

Chemotherapy (yes, current or

previously)

Previous/completed

Current

23 (88.5%)

20 (76.9%)

3 (11.6%)

24 (92.3%)

23 (88.4%)

1 (3.8%)

Radiotherapy (yes, current or

previously)

Previous/completed

Current

21 (80.7%)

20 (76.9%)

1 (3.8%)

23 (88.5%)

22 (84.6%)

1 (3.8%)

Hormone therapy (yes, current or

previously)

19 (73.1%)

21 (80.8%)

Other treatment

Herceptin

Herceptin and immunotherapy

(other)

2 (7.1%)

1 (3.8%)

3 (11.5%)

0 (0%)

Lymph node dissection (yes) 25 (96.2%) 24 (92.3%)

Number of lymph nodes removed 7.5 (1, 34) 12.8 (1, 30)

Time since diagnosis (months) 20 (5, 78) 20 (7, 82)

Time since treatment completion

(months)

10 (0, 54)

9 (1, 47)

Total number of treatment-related side

effects1

Mean (SD)


3.5 (1.7)

4 (1, 8)

2.5 (1.7)

2 (0, 6)

Overall symptom severity2

Mean (SD)


1.9 (0.6)

1.8 (1, 3)

1.5 (0.8)

1.5 (0, 3)

Number of comorbidities3

0

1 to 3

>3

8 (30.8%)

16 (61.5%)

2 (7.7%)

9 (34.6%)

15 (57.7%)

2 (7.7%)

Intervention completed in SAFE

5 supervised sessions

11 (43.3%)

14 (53.8%)

143

Meeting physical activity guidelines

(yes)4

20 (76.9%)

20 (76.9%)

Total MVPA5

Mean (SD)


113.6 (101.5)

60.0 (0.0, 480.0)

122.1 (100.9)

120.0 (0.0, 375.0)

Total activity6

Mean (SD)


271.8 (179.2)

185.0 (0.0, 840.0)

264.8 (178.6)

272.5 (0.0, 1140.0) 1 Treatment-related side effects included pain, fatigue, nausea, hair loss, sleep

problems/insomnia, peripheral neuropathy, arthralgia (joint pain), hot flushes,

lymphoedema, skin changes, upper-body morbidity (loss of strength, impaired

mobility), numbness or tingling in hands and feet, seroma formation, weight gain,

mood swings, cognitive issues, anxiety, depression, loss of finger or toe nails. 2 Severity ranged from 0 (symptom not present) to 3 (severe). 3 Comorbidities included cardiovascular disease, hypertension, high cholesterol,

high blood glucose, diabetes, heart attack, stroke, emphysema, chronic bronchitis,

arthritis, thyroid condition, peripheral vascular disease, osteoporosis, inflammatory

condition or asthma. 4 Self-reported based on the Active Australia survey, based on ‘total activity’

(walking + moderate activity + vigorous activity).

5 Does not include walking (moderate activity + vigorous activity). 6 Includes time spent walking (walking + moderate activity + vigorous activity).

MVPA: Moderate-to- vigorous intensity physical activity.

MRM: Modified radical mastectomy.

PAC: Physical activity counselling group.

PAC+F: Physical activity counselling plus Fitbit group.

SD: Standard deviation.



3.10.3 Primary outcome: physical activity levels

Objectively-assessed physical activity

Results of objectively-assessed physical activity at the 12-week follow-up are

shown in Table 3.2. Compared with the PAC group, there were trends for higher

MVPA (p=0.09) and steps per day (p=0.07) for those in the PAC+F group at the 12-

week follow-up, although results were not supported statistically.

Table 3.2

Comparison of objectively-assessed physical activity at the 12-week follow-up

between PAC and PAC+F

PAC

Median (min, max)

n=25

PAC+F

Median (min, max)

n=25

p-value

MVPA (minutes

per week)

128.3 (22.7, 508.2) 239.1 (32.5, 541.8) 0.09

Steps per day 4198.0 (469.8, 12178.3) 6310.7 (2238.8, 10238.1) 0.07

MVPA: Moderate-to-vigorous physical activity.



145

Self-report physical activity levels.

Results of self-reported physical activity at baseline and the 12-week follow-up

are shown in Table 3.3. Significant group by time interactions were observed for

minutes per week of moderate intensity physical activity (p=0.02) and total physical

activity (p=0.03). The PAC group showed reductions in moderate intensity physical

activity during the intervention (mean change: –45.8 [95% CI= –83.7, –7.8] minutes

per week, p=0.01) and total activity (mean change: –94.4 [95% CI= –177.4, –11.3]

minutes per week, p=0.02). No significant changes were observed in the PAC+F

group. At the 12-week follow-up, the PAC+F group was performing a significantly

higher amount of total activity, compared with the PAC group (between-group mean

difference: 112.2 [95% CI=12.5, 211.8], p=0.02). Findings from analysis of covariance

suggested that SAFE intervention group allocation had no effect on self-reported

physical activity outcomes (minutes per week of walking: p=0.32; MVPA: p=0.59;

total activity: p=0.69).

146 Chapter 3: The effect of a physical activity counselling session plus a Fitbit versus physical activity counselling alone on physical activity maintenance (Study 2, the SAFE-Maintain study)

Table 3.3Self-reported physical activity (minutes per week) at baseline and 12-week follow-up between the PAC and PAC+F groups

Minutes per week Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)

Change from baseline to 12

week

Mean (95% CI)

Between-group difference at

12 weeks

Mean (95% CI)

p-value

group × time

Walking (mins)

PAC

PAC+F

158.1 (120.3, 195.9)

142.6 (104.5, 180.8)

100.4 (62.4, 138.3)

168.8 (110.7, 226.9)

–57.7 (–106.9, –8.5)3

26.1 (–34.6, 86.9)

68.4 (–0.9, 137.8)4

0.08

Moderate-intensity

activity (mins)

PAC

PAC+F

69.2 (32.0, 106.3)

61.9 (30.1, 93.6)

23.0 (6.6, 40.4)

39.3 (14.0, 63.6)

–45.3 (–83.9, –7.7)3

–22.6 (–65.8, 20.5)

15.8 (–13.8, 45.5)

0.02

Vigorous-intensity

activity (mins)

PAC

PAC+F

44.4 (23.9, 64.8)

60.1 (35.8, 84.4)

50.4 (26.2, 74.7)

81.5 (53.9, 109.1)

6.0 (-16.3, 28.5)

21.3 (-12.8, 55.5)

31.0 (–5.7, 67.8)

0.21

Total MVPA (mins)1

PAC

PAC+F

113.6 (69.6, 157.6)

122.1 (87.1, 157.1)

73.8 (42.8, 104.9)

120.7 (79.4, 162.1)

–39.7 (–83.3, 3.8)

–1.3 (–57.9, 55.2)

46.8 (–4.7, 98.5)

0.07

Total activity (mins)2

PAC

PAC+F

271.8 (201.8, 341.7)

264.8 (210.1, 319.5)

177.3 (122.1, 232.6)

289.6 (206.7, 372.5)

–94.4 (–177.4, –11.3)3

24.8 (–75.4, 125.0)

112.2 (12.5, 211.8)4

0.03 1 Does not include walking (moderate activity + vigorous activity). 2 Includes time spent walking (walking + moderate activity + vigorous activity). 3 Represents statistically significant within-group change from baseline to the 12-week follow-up (p<0.05). 4 Represents statistically significant between-group difference at the 12-week follow-up (p<0.05).

MVPA: Moderate-to-vigorous physical activity; PAC: Physical activity counselling group; PAC+F: Physical activity counselling plus Fitbit group.

147

Proportions of participants meeting physical activity guidelines at the 12-

week follow-up.

The proportion of participants meeting recommended levels consistent with

physical activity guidelines at baseline (self-report) and the 12-week follow-up (self-

report and objectively-assessed) is shown in Table 3.4. At the 12-week follow-up, 16

participants (64%) in the PAC+F group and nine participants (36%) in the PAC group

were meeting physical activity guidelines based on objectively-assessed MVPA

(p=0.06). The proportion of participants meeting recommended levels of total activity

and MVPA in the PAC+F group was stable between baseline and the 12-week follow-

up. In contrast, the proportion of participants who were physically active in the PAC

group was less than half that of the PAC+F group at the 12-week follow-up (n=10,

38.5% vs. n=3, 12%, p=0.03).

Table 3.4

Proportion of participants meeting physical activity guidelines at baseline (self-report)

and 12 weeks (self-report and objectively assessed)

Method of measurement Meeting physical activity guidelines1 (Yes)

PAC (n, %) PAC+F (n, %) Chi-square Between

group p-value

Objectively-assessed: n=25 n=25

Total MVPA

12-week follow-up

9 (36%)

16 (64%)

5.67

0.06

Self-reported: n=25 n=26

Total activity2

Baseline

12-week follow-up

20 (80%)

13 (52%)

20 (76.9%)

20 (76.9%)

0.71

3.46

0.78

0.07

Total MVPA3

Baseline

12-week follow-up

8 (32%)

3 (12%)

12 (46.2%)

10 (38.5%)

1.07

4.69

0.31

0.03 1 Meeting national physical activity guidelines of at least 150 minutes per week of

moderate-intensity physical activity. 2 Includes time spent walking (walking + moderate activity + vigorous activity). 3 Does not include walking (moderate activity + vigorous activity).






Proportions of participants that increased, decreased or maintained their

physical activity between baseline and the 12-week follow-up.

The proportions of participants in each group that either increased or decreased

their physical activity by 30 minutes per week or more, or maintained their physical

activity (i.e. did not increase or decrease by 30 minutes per week or more) is shown in

Table 3.5. In the PAC and PAC+F groups, 44% and 42% (respectively) decreased their

MVPA, and 64% and 50% (respectively) decreased their total activity between

baseline and 12 weeks.

Table 3.5

Proportion of participants that either increased, did not change or decreased

physical activity between baseline and 12 weeks

Self-reported

physical

activity

outcome

PAC (n%) PAC+F (n%) Chi-

square

Between

group p-

value

Total MVPA1

Increase

No change

Decrease

n=25

5 (20%)

9 (36%)

11 (44%)

n=26

9 (34.6%)

6 (23.1%)

11 (42.3%)

1.72

0.42

Total physical

activity1

n=25 n=26

Increase

No change

Decrease

7 (28%)

2 (8%)

16 (64%)

11 (42.3%)

2 (7.7%)

13 (50%)

1.18

0.55 1 Increase by >30 minutes, decrease by >30 minutes or no change (did not

increase or decrease >30 minutes).




149

3.10.3.1 Secondary outcomes:

Quality of life and related outcomes

No significant group by time interactions were observed for each of the FACT-

G subscales and overall FACT-G score. (Table 3.6). However, the PAC group showed

a clinically relevant reduction in overall FACT-G score (mean change: –6.0 [95% CI=

-12.2, 0.1]), although this was not supported statistically.

There were no clinically relevant changes in outcomes obtained from the

PROMIS questionnaires between baseline and 12 weeks, with the exception of upper-

extremity function (Table 3.7). A clinically relevant worsening of self-reported upper-

extremity function was observed in the PAC group, which was supported statistically.

(mean change: –4.2 [95% CI=7.8, –0.5], p=0.02). Although not clinically relevant,

statistically significant group by time effects (all p<0.05) were observed for anxiety,

pain intensity, global health, physical health and mental health. The PAC group

showed a statistically significant improvement in anxiety and pain interference during

the intervention (p<0.05). Comparison of 12-week scores showed effects (p<0.05) in

favour of PAC+F for anxiety, pain interference, global health, physical health and

mental health.



Table 3.6

Quality of life (FACT-G and subscales) scores are baseline, 12 weeks and change

scores between intervention and control groups

FACT-G

quality of life

outcomes

Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)

Change from

baseline to 12

weeks

Mean (95% CI)

p-value

group ×

time

Overall (0–

108)

PAC

PAC+F

81.3 (75.7, 86.8)

81.3 (76.2, 86.4)

75.2 (68.5, 81.9)

80.0 (74.4, 85.5)

–6.0 (–12.2, 0.1)ǂ

–1.3 (–6.2, 3.6)

0.25

Physical

wellbeing (0–

28)

PAC

PAC+F

20.8 (19.1, 22.4)

22.0 (20.4, 23.6)

20.0 (18.0, 22.0)

22.9 (21.6, 24.2)

–0.7 (–2.3, 0.7)

0.9 (–0.4, 2.3)

0.08

Social/family

wellbeing (0–

28)

PAC

PAC+F

21.5 (19.1, 23.8)

21.1 (19.5, 22.7)

19.4 (16.9, 21.8)

19.0 (16.7, 21.3)

–2.1 (–4.2, 0.0)1

–2.1 (–4.4, 0.1)

0.07

Emotional

wellbeing (0–

24)

PAC

PAC+F

19.2 (17.7, 20.7)

18.2 (17.1, 19.4)

17.8 (15.9, 19.7)

18.3 (17.1, 19.5)

–1.3 (–2.8, 0.1)

0.1 (–1.0, 1.1)

0.32

Functional

wellbeing (0–

28)

PAC

PAC+F

19.7 (18.0, 21.5)

19.8 (17.9, 21.8)

17.9 (15.8, 20.1)

19.6 (17.4, 21.9)

–1.8 (–4.1, 0.5)

–0.1 (–2.0, 1.6)

0.44

Higher scores indicate higher quality of life/higher functioning. 1 Represents a statistically significant within-group change between baseline and the

12-week follow-up (p=0.05).

ǂ Represents a clinically relevant change between baseline and the 12-week follow-up

(>5 units).

FACT-G: Functional Assessment of Cancer Therapy – General.



151

Table 3.7

Quality of life (PROMIS-43 and all subscale, PROMIS Global short-form and PROMIS Upper-Extremity) scores at baseline, 12 weeks and

change scores between intervention and control groups

PROMIS outcomes Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)


Mean (95% CI)

p-value

group × time

Overall (0–205)

PAC

PAC+F

164.3 (154.9, 173.8)

170.6 (160.1, 180.3)

160.2 (150.1, 170.3)

173.4 (163.2, 183.6)

–4.1 (–14.4, 6.1)

3.1 (–4.4, 10.8)

0.34

Physical function

(0–30)

PAC

PAC+F

25.0 (23.1, 26.8)

26.6 (25.2, 28.0)

25.2 (23.6, 26.9)

26.8 (25.2, 28.5)

0.2 (–1.4, 2.0)

0.2 (–0.6, 1.2)

0.50

Anxiety (0–30)

PAC

PAC+F

25.5 (23.8, 27.1)

24.5 (22.5, 26.5)

23.3 (21.4, 25.3) 1

26.1 (24.7, 27.5)1

–2.1 (–4.4, 0.1)

1.5 (0.0, 3.1) 2

0.03

Depression (0–30)

PAC

PAC+F

27.3 (26.0, 28.5)

26.7 (25.3, 28.2)

25.1 (23.1, 27.1)

26.7 (25.3, 28.1)

–2.1 (–4.1, –0.2)2

0.0 (–1.4, 1.4)

0.18

Fatigue (0–30)

PAC

PAC+F

20.4 (18.3, 22.4)

21.9 (20.0, 23.8)

20.2 (18.2, 22.1)

22.4 (20.4, 24.3)

–2.2 (–5.0, 0.5)

0.4 (-1.2, 2.2)

0.47

Sleep disturbance

(0–30)

PAC

PAC+F

20.7 (18.3, 23.0)

21.9 (20.1, 23.7)

20.8 (18.5, 23.1)

21.5 (19.7, 23.2)

0.1 (–1.6, 1.9)

–0.4 (–2.2, 1.3)

0.86

Satisfaction with

social roles (0–30)

PAC

21.5 (19.6, 23.5)

21.6 (19.7, 23.5)

0.1 (–2.4, 2.5)

152 Chapter 3: The effect of a physical activity counselling session plus a Fitbit versus physical activity counselling alone on physical activity maintenance (Study 2, the SAFE-Maintain study)

PAC+F 22.1 (19.7, 24.5) 23.5 (21.3, 25.8) 1.4 (–0.4, 3.3) 0.34

Pain interference (0–

30)

PAC

PAC+F

23.8 (21.8, 25.7)

26.2 (24.3, 28.1)

23.8 (21.7, 25.9)

26.1 (24.3, 27.9)

0.0 (–2.0, 2.1)

–0.1 (–1.7, 1.5)

0.27

Pain intensity (0–10)

PAC

PAC+F

5.5 (4.7, 6.3)

6.6 (5.9, 7.4)

6.4 (5.7, 7.2) 1

7.6 (6.8, 8.4) 1

0.9 (–0.2, 1.3)

1.0 (0.2, 1.0)2

<0.01

Global health short

form, overall (10–

55)

PAC

PAC+F

34.7 (32.2, 37.2)1

38.8 (36.2, 41.4)1

33.5 (31.3, 35.7)1

40.5 (38.0, 43.1)1

–1.7 (–4.1, 0.7)

1.7 (–0.7, 4.1)

<0.01

Global physical

health (5–30)

PAC

PAC+F

15.5 (14.2, 16.8)1

17.8 (16.5, 19.1)1

15.3 (14.1, 16.5)1

18.8 (17.5, 20.1)1

–0.1 (–1.3, 0.9)

1.0 (–0.1, 2.0)

<0.01

Global mental health

(5–25)

PAC

PAC+F

13.1 (12.1, 14.1)

14.0 (12.9, 15.1)

12.2 (11.1, 13.3)1

14.4 (13.5, 15.4)1

–0.9 (–2.1, 0.3)

0.4 (–0.6, 1.5)

0.02

Upper-extremity (0–

80)

PAC

PAC+F

75.0 (73.0, 77.0)

77.5 (75.8, 79.1)

70.8 (67.0, 74.6)

78.5 (77.5, 79.4)

–4.2 (–7.8, –0.5)2ǂ

1.0 (–0.1, 2.0)

<0.01

ǂ Represents clinically relevant change. 1Represent a statistically significant between group difference at the 12-week follow-up. 2 Represents a statistically significant within-group change between baseline and the 12-week follow-up (p=0.05).


153






No statistically significant or clinically relevant change was observed for

exercise self-efficacy (Table 3.8).

Table 3.8

Exercise self-efficacy between baseline and 12 weeks for intervention and control

groups

Exercise self-

efficacy (%)

Baseline

Mean (95% CI)

12 weeks

Mean (95% CI)

Change from

baseline to 12

weeks

Mean (95% CI)

p-value

Mean, (0–100)

PAC

PAC+F

52.4 (46.0, 58.9)

47.2 (40.1, 54.2)

50.8 (43.6, 57.9)

49.2 (38.7,

59.6)

–1.6 (8.2, 1.0)

2.0 (-6.9, 7.3)

0.42

Higher scores indicate higher self-efficacy (Scale: 0= not confident at all;

100=extremely confident).



3.10.4 Fitbit feasibility

A summary of key Fitbit feasibility findings is described in the sections below.

Detailed results tables are included in Appendix O.

Wearing the device: Most PAC+F participants reported wearing the Fitbit ‘Most

of the time’ or ‘Always’ (n=22, 80.8%) during the 12 weeks. Mean wear time was 17.3

(SD=5.7) hours per day (out of 24 hours per day), and 6.1 (SD=1.5) days per week

(out of 7 days per week). The two most common reasons for not wearing the Fitbit on

certain days were due to the device requiring charging or low battery (n=17, 65.4%)

and forgetting to wear it (n=12, 46.2%). One participant (4%) reported not regularly

wearing the Fitbit due to skin irritation or discomfort.

Effect during the 12-week period: Most participants responded ‘Somewhat’ or

‘Very much’ when asked if using the Fitbit helped to increase their physical activity

(n=18, 69%), assist with self-monitoring (n=21, 81%) and meet their physical activity

targets (n=19, 73%) during the intervention. In the final week of the intervention, most

participants (n=20, 77%) reported that the Fitbits caused them to increase their

155

physical activity, whereas three (12%) participants reported that it caused them to

reduce their physical activity.

Viewing the Fitbit: The most commonly viewed feature or measure was daily

steps, with over half of participants (n=15, 58%) viewing daily steps on the display

screen four or more times per day, while two participants (8%) reported not viewing

their steps in a typical day. Nine participants (35%) viewed their heart rate four or

more times per day, while 58% (n=15) did not view their heart rate (in a typical day).

The least viewed measure was energy expenditure, with over half of participants (57%,

n=15) not looking at their energy expenditure in a typical day. When looking at the

display screen to view their physical activity data, the most common reason was to

determine whether they had reached their daily physical activity goal (n=19, 73%).

Uploading data and using the website or App: Almost half of participants

(n=11, 42%) uploaded their data onto a computer or smart phone at least once per

week, and 10 (39%) participants viewed their data at least once per week (n=5, 19%

participants did not upload their data; n=6, 23% did not view their data). The most

common reasons for using the website or mobile application were to look at their

physical activity graphs in more specific detail (n=17, 65%), to look at their progress

over the 12 weeks (n=12, 46%), and because the graphs and daily/weekly/monthly

summaries were an easy way to monitor physical activity over time (n=10, 38%).

Participants’ perceptions of the barriers and dislikes related to the Fitbit:

Major themes that were identified in relation to positive aspects of the Fitbit in helping

them to maintain their physical activity were: goal-setting and sense of achievement,

feedback and self-monitoring, and motivation. Major themes that were identified in

terms of limitations of the Fitbit were the inability to monitor certain activities,

including water-based exercise (i.e. the Fitbit was not waterproof), forgetting to wear

the device, having to charge it regularly or forgetting to charge it, and technical

difficulties with uploading physical activity data using the App or website.

Satisfaction and plans for future use: Most participants reported that the Fitbit

was easy to use (n=24, 92%), and comfortable to wear (n=22, 84%). Overall they were

satisfied with how the device assisted them to meet their weekly physical activity goals

(n=23, 88%). Twenty-five participants (96%) said they would continue to use an

exercise tracker in the future.



3.10.4.1 Summary of Fitbit feasibility and acceptability results

A summary of all feasibility and acceptability outcomes with respect to the

predefined criteria are shown in Table 3.9. All five pre-defined criteria were met.

Overall, the Fitbit was feasible and acceptable as a device to support physical activity

maintenance among women with stage II+ breast cancer.

Table 3.9

Summary of Fitbit feasibility and acceptability outcomes with respect to study

objectives

Outcome Study Result Predefined

criterion

Feasibility or

acceptability

criteria met?

(Yes or no)

Feasibility

Compliance with wearing

the Fitbit, mean (SD)

6.1 (1.8) days

/week

17.5 (5.7)

hours/day

Device is worn

for:

>5 out of 7

days/week and

>10 hours/day

Yes

Acceptability

Ease of use 92% >80% Yes

Comfortable to wear 84% >80% Yes

Overall Fitbit satisfaction 88% >80% Yes

Plans for continued use 96% >80% Yes

157

3.11 DISCUSSION

3.11.1 Overview of key findings

Findings from this work suggest that the combination of a counselling session

on physical activity maintenance and use of a physical activity tracker (i.e. a Fitbit)

may be more effective for maintaining physical activity levels over a 12-week period

compared with a counselling session alone. Further, use of a physical activity tracker

was feasible and acceptable for women with stage II+ breast cancer.

3.11.2 Primary outcomes (physical activity)

Participants in the PAC+F group maintained physical activity levels during the

12-week follow-up period. In contrast, those in the PAC group showed reductions in

both self-report MVPA and self-report total activity, and as such, by the 12-week

follow-up, PAC+F participants had higher physical activity levels overall. The

differences at the 12-week follow-up in self-report MVPA and self-report total activity

between groups was 47 and 112 minutes per week (respectively), both of which were

clinically relevant, although not supported statistically. At 12 weeks, 77% of the

PAC+F group, compared with 52% of the PAC group, were meeting national physical

activity guidelines.

Findings from SAFE-Maintain support previously reported findings by others

that suggest that pedometers and physical activity trackers appear most effective for

promoting walking [270, 289, 304, 305]. For example, in the PAC+F group, change in

MVPA was –1 minute per week, while change in walking was +26 minutes per week

(which is approaching a clinically important value of 30 minutes per week). This may

be because walking is highly convenient (i.e. it does not require exercise equipment),

and is a preferred mode of exercise for women with breast cancer [306]. Further,

walking was the most common AEP recommended form of aerobic exercise during

SAFE and during the physical activity counselling session in SAFE-Maintain (in

response to participants’ preferences and their exercise behaviour in SAFE). Also of

note, the degree of supervision received as part of the SAFE intervention (i.e. five or

20 supervised sessions) was not associated with effects on physical activity in SAFE-

Maintain. This suggests that Fitbit use may promote longer term maintenance,

irrespective of the previous level of exercise supervision that a participant has

received.



3.11.2.1 Comparison to similar studies

SAFE-Maintain suggests use of a Fitbit could prove beneficial with respect to

maintaining physical activity levels in newly, sufficiently active women with breast

cancer. The findings from SAFE-Maintain build on previous findings that have shown

variable potential for pedometers or physical activity devices to increase or maintain

longer term physical activity levels when incorporated as part of the initial intervention

[210, 279]. Specifically, findings from SAFE-Maintain provide the first, preliminary

results that suggest introducing a Fitbit as supervision from AEPs starts to decline may

prove beneficial with respect to maintaining physical activity levels. These represent

important practical findings for AEPs, as they could consider pedometers and Fitbits

as part of the toolbox they can draw from to help women with breast cancer to become

and stay sufficiently active.

The findings that 64% of the PAC group who showed a reduction in physical

activity during the 12-week follow-up period of SAFE-Maintain is consistent with

previous findings that show physical activity levels decline following completion of a

supervised intervention and in the absence of ongoing intervention [307]. Further, the

reduction in total activity of approximately 95 minutes per week observed in the PAC

group represents almost two-thirds of the recommended 150 minutes per week of

physical activity. The changes observed in the PAC group underscore the importance

of finding acceptable and feasible tools and strategies that can prevent these adverse

changes in physical activity observed to occur when supervision is no longer provided.


Higher levels of physical activity are associated with favourable effects on

various quality of life and associated outcomes [308]. Therefore, the clinically relevant

differences at the 12-week follow-up and change between baseline and follow-up

observed for quality of life and related outcomes between the PAC and PAC+F group

were not surprising. Specifically, during the 12-week follow-up period, the PAC group

showed clinically relevant declines in overall quality of life (assessed using the FACT-

G) and self-report upper-extremity function, while the PAC+F group showed

maintenance or improvement in these outcomes. By the 12-week follow-up, the PAC

+F group reported higher global, physical and mental health and lower pain and

anxiety (p<0.05) compared with the PAC. These findings underscore the importance

of keeping women active in the longer term.

159

3.11.2.3 Exploratory outcomes: Fitbit feasibility and acceptability

Feasibility

As was expected, recruitment and retention in SAFE-Maintain was high (96%

and 98%, respectively). SAFE-Maintain involved recruitment of a motivated sample

(women who were completing SAFE and were keen for any additional physical

activity support that the research could provide). Time requirements for participation

in SAFE-Maintain were also low (one counselling session and one additional data

collection session). Similarly, previous trials have that have evaluated Fitbit- [268] and

pedometer-based [210, 247, 279] interventions among women with breast cancer (but

that have required greater time commitments from participants compared with SAFE-

Maintain) have also reported high recruitment and retention rates (ranging between

70% to 90%) [210, 247, 267, 268, 279]. Nonetheless, it is important to consider the

circumstances of the two participants who completed SAFE but refused to participate

in SAFE-Maintain. One woman declined to participate due to disease progression,

while the other stated reasons relating to commencing new treatments. It is plausible

that these two women were at greatest risk of experiencing declines in physical activity

levels and other health and function outcomes, potentially biasing the results presented

above in the least conservative direction. Moreover, one participant in the PAC group

was lost to follow-up. This participant was also more likely to have experienced a

reduction in physical activity during this time. As such, omission of her data may have

meant that physical activity levels of the PAC group were higher at 12 weeks than they

would have been if her data had been included. Acknowledging this potential

recruitment and retention bias is important to ensure that the findings of SAFE-

Maintain are not overstated, and to highlight that women in most need for longer-term

advice and support may be the most difficult to engage and require more intervention

support.

Although no additional assistance or reminders were provided to wear the device

during the 12 weeks, feasibility data indicated that participants were highly engaged

with the Fitbit. Similar to the findings of SAFE-Maintain, in a 12-week RCT which

involved a Fitbit-based physical activity intervention involving women with breast

cancer (n=42), participants wore the Fitbit on an average of six out of seven days (mean

adherence to wearing the Fitbit was 89% of valid days over 12 weeks) [267]. High

satisfaction towards a Fitbit was also reported in a trial involving mixed cancer



survivors (breast cancer: n=14, 58%; other, cervical, leukemia, urinary, melanoma,

rectal, oral, ovarian, and prostate: n=10, 42%), with 87% of participants self-reporting

to be ‘satisfied’ with the device [268]. Similarly, a Fitbit was also shown to be

comfortable to wear and easy to use in a three-week study among men with prostate

cancer (n=26) [265]. Greater than 90% of PAC+F participants in SAFE-Maintain were

willing to continue using a physical activity tracker in the future, although data relating

to the amount of money participants would be willing to pay for a device was not

assessed. However, a cost of AUD $100 to 150 was considered an acceptable out-of-

pocket cost in a previous feasibility study of women with breast cancer [289]. Overall,

these exploratory findings from SAFE-Maintain are consistent with previous findings

involving mixed [268] and prostate cancer survivors [265], and suggests that Fitbits

are acceptable among women with breast cancer, and are easily integrated into their

daily lives.

Acceptability

The findings of this work also support the Fitbit as being acceptable for helping

to maintain physical activity. Major themes that were identified in relation to positive

aspects of the Fitbit were: self-monitoring, self-awareness, motivation, goal-setting,

feedback and sense of achieving goals. Most PAC+F participants (69 to 73%) said the

device helped to increase their physical activity, assist with self-monitoring and meet

their physical activity goals. Participants reported that the ability to self-monitor led to

increased self-awareness of their physical activity and motivation to incorporate more

activity into their daily routines (e.g. fitting in more walking throughout the day when

possible). Consistent with this, prior findings have reported that a pedometer was

regarded by participants as motivating and encouraging (n=42, 40%); it also increased

self-awareness of physical activity levels (n=35, 34%) [245]. Vallance et al. [245]

reported that 79% (n=104) of participants felt that the pedometer helped to increase

their physical activity during a previous 12-week RCT involving women with breast

cancer (n=377). Further, in a qualitative evaluation of preferences for wearable

physical activity trackers in women with breast cancer [289], most participants (86%,

n=12) liked receiving real-time feedback of their behaviour on the device or on the

Apps. Even though many participants (69%, n=18) in the PAC+F group perceived that

the Fitbit helped to increase their physical activity, physical activity outcome data

indicated that 42% (n=11) of the PAC+F participants increased their activity (by 30

161

minutes per week or more), whereas 50% (n=14) reduced their physical activity (by

30 minutes per week or more). This indicates that the low intensive intervention to

support physical activity maintenance in the absence of supervision may be

insufficient for some women. Alternatively, participants may have increased certain

types of physical activity, which were measured differently by the two methods (e.g.

minutes per week of walking is obtained from the self-report questionnaire, while steps

per day and minutes per day of MVPA was obtained objectively). Participants may

also have reduced their participation in other exercise types (e.g. resistance exercise,

which was not specifically measured by either of the instruments).

Most participants (>80%) did not encounter technical difficulties in operating

the basic features of the device and associated App or website and most were able to

independently learn to use the device as desired to support physical activity. Similar

to previous findings involving the general older population [271] and women with

breast cancer [289], participants in the PAC+F group liked the simple features of the

physical activity trackers. This included the clear and achievable step-goal display,

instant feedback and simplicity and easy-to-use design of the Fitbit. Further, these

features were considered important to participants. Acceptability data from SAFE-

Maintain indicated the most commonly viewed measure was daily steps, with over half

of participants (n=15, 58%) viewing their daily step counts on the Fitbit at least four

times a day. Qualitative comments indicated that participants reported feeling

motivated and satisfied knowing that they achieved the targeted number of steps for a

day. This suggests that PAC+F participants were highly aware of their daily steps and

self-monitored their steps multiple times throughout the day. It seems plausible that

this information was then used to adjust their activity to meet their daily physical

activity goals. These findings were consistent to those previously reported in a

qualitative evaluation of preferences for wearable physical activity trackers for women

with breast cancer that showed step counts were the most preferred feature of devices

[289].

The most common reasons why participants viewed the device’s display screen

were to look at how much activity they had completed that day and if they had reached

their daily goal (n=19, 73%), while 42% (n=11) uploaded and viewed their data onto

a computer or smart phone at least once per week. Self-reported viewing of physical

activity information on the Fitbit itself, or on the website or App, was high and most



participants (>80%) preferred monitoring physical activity with the device itself, or in

combination with the Fitbit website or App. This supports the previous findings that

physical activity trackers may encourage greater awareness of behaviour when an

individual views and responds to feedback provided on the tracker or associated

website and App [249, 258]. For example, in a previous RCT, Hartman et al. [267]

stated that 68% (n=27) of participants reported looking at the Fitbit tracker itself, and

68% (n=27) reported looking at their activity data on the App or website at least once

a day. Consistent with the theory of planned behaviour [223, 224], these behavioural

practices (i.e. self-monitoring and goal-setting) may be important for successfully

increasing and maintaining physical activity [224]. Overall, the findings from SAFE-

Maintain are consistent with previous findings and participant impressions of the

Fitbits were positive. Participants generally enjoyed wearing and using the Fitbit and

suggested that they found them helpful in keeping physically active in the absence of

ongoing supervision.

3.11.3 Barriers and dislikes

The two most common reasons for not wearing the Fitbit on certain days were

that the device requiring charging (i.e. low battery, n=17, 65%) and forgetting to wear

it (n=12, 46%). One participant (4%) reported not regularly wearing the Fitbit due to

skin irritation or discomfort, although this participant reported wearing it ‘sometimes’

during the 12 weeks. Similarly, Nguyen et al. [289] reported that two participants

(14%) experienced discomfort with wear, suggesting that discomfort may be an issue

for a small proportion of participants. The most frequently reported reasons for

irregular or limited use during a 6-month follow-up period in previous RCT involving

women with breast cancer (n=377) [245] were forgetting to wear it or losing it (forgot:

n=15; lost: n=8, 27%), the pedometer was awkward (n=10; 12%), and the pedometer

malfunctioned or stopped working (n=8; 10%). Although forgetfulness appears

common, it is important to consider that SAFE-Maintain was 12 weeks, compared with

a 6-month follow-up reported by Vallance et al. [245]. Therefore, issues such as losing

devices and malfunctions may become more common over longer periods of use.

Further, PAC+F participants experienced some minor technical difficulties when

setting up the device and regularly syncing and uploading their physical activity data

to the mobile application or website. Minor issues have been reported previously in

the literature. For example, Nguyen et al. [289] reported in their study with breast

163

cancer that two participants (14%) found it challenging setting up the device,

synchronising and understanding how to use the App. In a 3-week study that evaluated

the Fitbit acceptability among men with prostate cancer (n=26), technology-related

difficulties were identified as minor barriers to use [265]. Certain features of the Fitbit

were not well used by participants. For example, in SAFE and SAFE Maintain,

participants received exercise prescription and education around monitoring exercise

intensity using heart rate. However, one in four participants did not use the heart rate

feature to monitor exercise intensity. Another barrier or dislike was the limited ability

of the Fitbit to monitor and record certain activities, mostly non-walking-based

activities. These reflect activities that participants wanted recognised as they counted

towards meeting their physical activity goals. Therefore, in the absence of

individualised instruction and regular advice on how to most effectively use the Fitbit,

some participants may not have used their Fitbit optimally during the 12-week period.

3.12 STUDY LIMITATIONS AND STRENGTHS

SAFE-Maintain was underpowered to detect clinically relevant differences in

physical activity as statistically significant. Further, these findings may only be

generalisable to women who have recently become sufficiently active following

participation in a 12-week intervention that involved the provision of an individualised

exercise prescription and significant behaviour change advice. It is therefore unclear

whether the potential benefits of use of a Fitbit for maintaining physical activity levels

would be the same for women who had not previously been exposed to the SAFE

intervention. The use of self-report questionnaires to assess physical activity changes

between baseline and the 12-week follow-up is also a potential limitation. That is, it is

possible that recall bias or social desirability bias may have influenced self-reporting

of physical activity and resulted in an over-reporting of physical activity (both at

baseline and follow-up). Of note, objectively-assessed physical activity using

accelerometry was obtained at the 12-week timepoint. Objectively-assessed physical

activity can overcome some of the limitations around self-report activity. Findings

reported here show a notable difference between self-reported and objectively-

assessed physical activity. This finding is consistent with a recent study [324] which

indicated poor agreement between self-reported and objectively-assessed physical

activity among women with breast cancer. It is important to consider that self-report

methods tend to overestimate physical activity compared with objectively assessed



methods. However, while absolute values of PA levels differ between the two

methods, differences between groups were consistent, irrespective of method of

assessment There was also double the number of women in the PAC that were

currently undergoing treatment during the study compared with in the PAC+F (n=4

and n=2 respectively), and therefore women undergoing treatment may require more

support for maintaining physical activity. Although there was some imbalance of

baseline characteristics, both groups were balanced at baseline with respect to weekly

physical activity levels.

The SAFE-Maintain follow-up period was relatively short. Achieving the

maintenance stage of change can take 9 months to 5 years for individuals [216] and it

is plausible that the potential longer-term effect of a Fitbit on physical activity

maintenance is less than that observed here. Nonetheless, SAFE-Maintain is the first

study in the cancer survivorship setting to specifically evaluate the potential role of

providing a physical activity tracker at the point of supervision decline on longer term

physical activity maintenance. The positive, albeit preliminary findings, highlight that

physical activity trackers may be a cost-effective and feasible strategy for promoting

longer term physical activity, and are therefore in need of future research attention. As

newer models of Fitbit are released on the market regularly (approximately once every

six months), with these newer devices typically including new and more innovative

technology and features and updated designs, their potential for making a difference

to physical activity levels may continue to improve.

Additional strengths of this study include the randomised controlled trial design,

high retention (98%) and use of objectively-measured physical activity data at 12

weeks. Objective evaluation of physical activity at the 12-week time point provided

the opportunity to objectively compare the two SAFE-Maintain groups at the 12-week

follow up. These objective data provide strength to what was observed with the self-

report physical activity data. Specifically, findings in differences between objective

and self-report data of the two groups at the 12-week follow-up were consistent.

Another strength of the study is that three months prior to enrolment, the sample was

insufficiently physically active. Therefore, the sample investigated were newly

sufficiently active women who were arguably at high risk of declines following

completion of SAFE. As such, they represent the ideal sample for SAFE-Maintain and

165

show that the addition of a Fitbit seemed to benefit overall, although some women

more than others.

3.13 CLINICAL IMPLICATIONS AND SUMMARY

The present findings showed that following the completion of a supervised

exercise intervention, physical activity trackers plus behaviour change education may

prove effective for maintaining physical activity.

This is relevant because long-term physical activity is associated with important

health and survival benefits. However, reliance on regular and ongoing AEP

supervision to support long-term physical activity is largely unfeasible and cost-

prohibitive for most women with breast cancer. Further, many healthcare systems may

not have the available resources (e.g. financial, staffing) to provide ongoing support

and supervision for long-term physical activity [309]. SAFE-Maintain provides

evidence for a potential approach to support physical activity maintenance among

women with breast cancer in a real-word setting. Therefore, these findings may have

important financial and cost implications for women with breast cancer, as well as to

healthcare systems. Apart from providing evidence for a potential strategy to promote

long-term maintenance, several practical recommendations were generated from this

study.

Physical activity trackers may be an important tool to supplement AEP-

supervised exercise and provision of behaviour change advice and support. SAFE-

Maintain involved implementing a physical activity tracker following completion of a

12-week supervised intervention, which involved an individualised exercise

prescription. However, future interventions may also benefit from implementing

physical activity trackers in conjunction with AEP supervision (i.e. at the same time).

Furthermore, the devices should be combined with theory-based physical activity

counselling which is specifically focussed on promoting longer-term maintenance.

Participants received comprehensive physical activity behaviour change education

during the counselling session, as well as during the 12-week SAFE intervention. This

involved behaviour change techniques, counselling and education on the benefits of

exercise, appropriate amount of exercise, goal-setting, self-monitoring and identifying

and overcoming barriers to promote longer term physical activity. Therefore, it is



important that physical activity trackers are combined with AEP supervision and

behaviour change education around physical activity maintenance.

The identified barriers and dislikes related to the device highlight important

issues and areas for education that must be considered (and addressed when relevant)

when implementing the devices. These include the non-individualised pre-

programmed daily step goal of 10, 000 steps per day, limited knowledge on how to use

several features, as well as how to use the Fitbit to monitor resistance exercise and

other non-walking-based activities. AEPs should expect to work with patients in

overcoming their identified barriers to promote usage and adherence on an individual

basis.

Specific education on using the physical activity tracker may be required to

enhance their effectiveness in clinical settings. SAFE-Maintain participants did not

receive specific or individualised physical activity goals based on the physical activity

tracker. However, participants expressed that they would have liked to receive

instruction about how they could most effectively use the physical activity tracker, as

well as individualised feedback on their progress. There was a preference towards self-

monitoring steps over other device features, with participants showing an increase in

walking, while MVPA (which comprised mainly of resistance exercise) was

maintained. Walking may have been preferred during the 12-week period due to

convenience and access to equipment. However, the non-individualised (pre-

programmed) daily steps goal of 10,000 steps per day was unsuitable for many

participants and participants expressed uncertainty around appropriate daily step goals

and appropriate progression. This should also include education around appropriate

goals during treatment compared with following treatment, as well as appropriate

progression of steps over time.

This work suggests that physical activity trackers may be an appropriate tool for

supporting longer term behaviour change. When implemented, AEPs need to work

with the patient to ensure they understand how the tracker can aid goal-setting and

monitoring, and need to work with the patient in identifying and problem-solving any

barriers that may present with the use of the device. For example, those who did not

benefit from a Fitbit may have been more responsive to text message prompts, or

additional AEP sessions or scheduled group sessions. Alternatively, the provision of

more advice with respect to using the physical activity tracker and its supporting

167

mobile application and website, rather than just the physical activity tracker, may have

made a difference to activity levels. Also, understanding at what stage of behaviour

change the introduction of strategies, such as physical activity trackers, is most

effective for most women requires further investigation. That is, it is important to

consider that women may benefit more from the inclusion of an activity monitor from

the beginning of a highly supervised intervention and that, as the level of supervision

and support is tapered away, reliance on feedback from the activity monitor is

increased. When implemented, AEPs need to work with the patient to ensure they

understand how the tracker can aid goal-setting and monitoring, and need to work with

the patient in identifying and problem-solving any barriers that may present in the use

of the device. Ultimately, this will ensure that the device is integrated and used in a

targeted and individualised manner.

Physical activity trackers require minimal resources and AEP oversight, and

represent an intervention that could be feasibly implemented within one supervised

visit with an AEP. A Fitbit may require out-of-pocket purchase from participants;

however, several Health Insurance Plans in Australia now cover the cost of a Fitbit.

Alternately, AEP clinics could include Fitbits as a part of their exercise equipment

inventory in the same way as other standard exercise equipment (e.g. Thera-bands,

treadmills, resistance exercise machines, heart rate monitors and free-weights).

Overall, physical activity devices could be considered a low-cost approach that have

potential benefits and there are currently rebate or reimbursement schemes in place to

support their use. AEPs need to remember that a tracker represents just one potential

strategy in their toolbox to ensure longer-term physical activity maintenance, and that

not all patients will be interested in using it or find its use beneficial.

168 Chapter 4: Future research and conclusions

Chapter 4: Future research and conclusions

4.1 SAFE

The intent of SAFE (Study 1) was to evaluate the safety, feasibility and

effectiveness of exercise in women with stage II+ breast cancer who were considered

to have a high disease burden (i.e. physically inactive women with multiple treatment-

related side effects and/or comorbidities). The findings suggested that this subgroup

of women with breast cancer who have previously been under-represented in exercise

trials can safely participate in a pragmatic, real-world exercise intervention involving

five AEP supervised sessions. However, the weekly exercise target set for the

intervention, which was equivalent to physical activity levels widely recommended as

appropriate for all women with breast cancer, was feasible only for the minority;

specifically, only one in three women met the intervention target during each week of

the intervention. Further, although participating in the intervention was associated with

clinically relevant mean improvements in various health-related outcomes, up to 39%

of participants showed either no change or a decline in fitness, quality of life, upper

body strength, fatigue, sleep, physical function, mental function and physical activity.

As such, even though five AEP supervised sessions supporting the intervention was

associated with average gains in patient outcomes, more support is needed to accrue

benefit for specific women.

All exercise-related adverse events were classified as low-grade (i.e. grade 1 or

2 in severity) and no events adversely influenced intervention participation. Overall,

adverse event risk appears low, including during the early stages of commencing

exercise. This suggests that five AEP sessions, which involved exercise prescription

and behaviour change advice and support, are sufficient to ensure exercise safety.

However, it needs to be remembered that the AEP sessions specifically included the

provision of safety education relating to the importance of incorporating warm-ups and

cool-downs into each session. Other components included clear instruction (supported

when necessary by written material) regarding safe exercise technique (e.g. how to

measure intensity, how to perform strength exercises properly), alongside how to

monitor treatment-related side effects and exercise response and what to do if

symptoms or side effects worsen. Therefore, these are aspects of exercise prescription

169

that AEPs need to ensure they include and address as part of their contact with patients.

Despite these positive safety findings, AEPs also need to ensure they do not become

complacent with safety. It remains possible for exercise to contribute to a worsening

of symptoms or an adverse event. There is also the need to help patients overcome any

fear they have with respect to exercise and new or worsening symptoms. The strategy

used in SAFE to help women manage any fear was to help them develop a clear

understanding of the relationship between exercise and symptom response. Further,

acknowledging risk of injury through exercise, educating ways in which a woman can

reduce risk and what to do if an event occurs are also important both in the short and

longer term.

The intervention was considered feasible for some but not all. Although over

half of participants (59%) met exercise targets >75% of the time (i.e. 9 of the 12

weeks), the majority (63%) could not meet targets during the entire 12 weeks (Table

2.15). This highlights the need for caution in promoting that physical activity

guidelines [5, 9, 10] are optimal weekly exercise targets for all women with breast

cancer. Instead, exercise prescription and targets need to be individualised, with

general physical activity principles [5, 9, 10, 295] of commencing exercise at a low

(achievable) dose (i.e. a low starting level), with gradual progression in physical

activity levels over time appropriate for guiding direction of prescription. Importantly,

an individualised exercise prescription must be delivered in conjunction with physical

activity behaviour change education. This should involve education around planning,

goal-setting, identifying and overcoming barriers, the benefits of long-term exercise,

and management of treatment-related side effects in order to promote more

independent and long-term exercise habits. Overall, performing some level of exercise

and physical activity is better than performing none (with more generally better than

less) and that it is never too late to start are particularly important messages for women

with breast cancer who are dealing with ongoing treatments, fluctuating treatment-

related concerns and comorbidities. It does seem plausible that with more supervision

and support, women may be able to meet physical activity levels promoted in cancer

guidelines more quickly, and that in doing so, more women would accrue benefits in

health outcomes. Future research is required to evaluate in more detail these

supervision requirements and what patient characteristics influence these

requirements. That is, improved understanding of who would benefit from the timing

170 Chapter 4: Future research and conclusions

and frequency of supervised sessions within and beyond the current reimbursable

scenario in Australia is needed. Of note, participants who met (n=6) versus those who

did not meet (n=21) the intervention target in week 1 averaged 147.7 (SD: 57.4) and

115.4 (SD: 66.1) minutes per week during the 12 weeks, respectively. Therefore,

compliance in week 1 may be a potential indicator of the need for additional support

and advice.

Participating in the intervention was associated with clinically relevant

improvements in survivorship health outcomes at the group level. However, between

46% and 78% of participants failed to show benefit in certain outcomes between

baseline and post-intervention assessment. As such, AEPs need to have a way of

determining who is responding to the intervention and who is not, and for those who

are not, why and what can be done about it. This highlights the need for a more flexible

reimbursement model, which would allow for the provision of greater supervision for

those who need it. Until this changes, the inequities of the current health system are

noted; only those who can afford it will be able to benefit from additional AEP

sessions. Further, AEPs need to help patients identify and utilise other available and

affordable resources or programs (e.g. identifying and seeking community programs,

telephone-based support or online resources) to benefit health outcomes. Overall,

SAFE provides information about safety, feasibility and potential effectiveness of a

supervised exercise intervention delivered using five supervised sessions with an AEP.

4.2 SAFE-MAINTAIN

SAFE-Maintain (Study 2) evaluated the role of adding a physical activity tracker

to traditional physical activity counselling in the maintenance of physical activity

levels. Mean weekly physical activity levels at the 12-week follow up remained the

same as baseline levels for women in the group that received a physical activity tracker

(Fitbit) in addition to a one-off physical activity counselling session. In contrast, mean

physical activity levels decreased for those who only received the one-off physical

activity counselling session (the PAC group). The PAC group also showed a clinically

relevant worsening in quality of life (assessed using the FACT-B, (p>0.05) and upper-

extremity function (p<0.05), compared with no change observed in these outcomes for

the PAC+F group (i.e. a maintenance). Further, comparison of 12-week scores showed

statistically significant effects (p<0.05) in favour of PAC+F for anxiety, pain

interference, global health, physical health and mental health compared with PAC. As

171

such, the positive effect observed on physical activity levels and patient-reported

outcomes, alongside findings that support the physical activity trackers as being

feasible and acceptable to use, highlight this as a potential strategy that AEPs can

implement to help promote longer-term physical activity. This has particular utility

potential in the Australian health system, whereby by the ability to provide exercise

and physical activity supervision, advice and support is limited.

Nonetheless, while group means of physical activity levels support the use of a

tracker, individual change highlights that physical activity trackers were not effective

for all women. Specifically, 50% of the women given a tracker to help maintain

physical activity levels showed reduced weekly physical activity levels by >30 minutes

per week more at the 12-week follow-up. These individual change results suggest the

need for more research to help understand who benefits from what tools and strategies,

and why, and how this information can then be used to help the majority of women

stay active for the longer term. As is the case with exercise prescription, the provision

of longer-term physical activity behaviour change strategies, such as the use of a

physical activity tracker, also needs to be targeted and individualised.

4.3 OVERALL SUMMARY

This research provides evidence to support that the five Medicare-funded visits

can provide, at the very least, a foundation from which exercise prescription could be

integrated among breast cancer care for women with stage II+ disease who are

experiencing multiple treatment-related side effects and comorbidities. This works

also supports AEPs making use of a range strategies that could help women maintain

physical activity in the longer term.

Bibliography 173

Bibliography

1. Cancer Australia. Report to the nation - breast cancer 2012, Cancer Australia,

Surry Hills, NSW, 2012.

2. Australian Institute of Health and Welfare 2014. Cancer in Australia: an

overview 2014. Canberra: Australian Institute of Health and Welfare.

3. Baumann, F. T. (2013). Physical exercise programs following cancer

treatment. European Review of Aging and Physical Activity, 10(1), 57-59.

4. Hayes, S. C., Rye, S., DiSipio, T., Yates, P., Bashford, J., Pyke, C., Eakin, E.

(2013). Exercise for health: a randomized, controlled trial evaluating the

impact of a pragmatic, translational exercise intervention on the quality of life,

function and treatment-related side effects following breast cancer. Breast

Cancer Research and Treatment, 137(1), 175-186.

5. Hayes, S. C., Spence, R. R., Galvão, D. A., & Newton, R. U. (2009).

Australian Association for Exercise and Sport Science position stand:

Optimising cancer outcomes through exercise. Journal of Science and

Medicine in Sport, 12(4), 428-434.

6. Courneya, K. S. (2014). Physical activity and cancer survivorship: a simple

framework for a complex field. Exercise and Sport Sciences Reviews, 42(3),

102-109.

7. Hayes, S. C., Steele, M. L., Spence, R. R., Gordon, L., Battistutta, D.,

Bashford, J., Eakin, E. (2018). Exercise following breast cancer: exploratory

survival analyses of two randomised, controlled trials. Breast Cancer

Research and Treatment, 167(2), 505-514.

8. Breastcancer.org. (2015). Exercise During and After Treatment. Retrieved

from: http://www.breastcancer.org/tips/exercise/treatment.

9. Cormie, P., Atkinson, M., Bucci, L., Cust, A., Eakin, E., Hayes, S., & Adams,

D. (2018). Clinical Oncology Society of Australia position statement on

exercise in cancer care. The Medical Journal of Australia, 209(4):184-187.

10. Schmitz, K. H., Lucia, A., Schneider, C. M., von Gruenigen, V. E., Schwartz,

A. L., & Courneya, K. S. (2010). American College of Sports Medicine

roundtable on exercise guidelines for cancer survivors. Medicine and Science

in Sports and Exercise, 42(7), 1409-1426.

11. Ferlay J., Soerjomataram I., Dikshit R., Eser S., Mathers C., Rebelo M.,

Parkin D.M., Forman D., & Bray F. (2015). Cancer incidence and mortality

worldwide: sources, methods and major patterns in GLOBOCAN 2012.

International Journal of Cancer. 136(5), 359-386.

12. Spence, R., DiSipio, T., Schmitz, K., & Hayes, S. (2014). Is unsupervised

exercise following breast cancer safe for all women? International Journal of

Physical Medicine & Rehabilitation, 2(3), 1-8.

13. Australian Government Department of Health (2015), Chronic disease

management - patient information. Retrieved from

http://www.health.gov.au/internet/main/publishing.nsf/content/mbsprimaryca

re-chronicdiseasemanagement.

14. Eakin, E. G., Lawler, S. P., Vandelanotte, C., & Owen, N. (2007). Telephone

Interventions for Physical Activity and Dietary Behavior Change: A

Systematic Review. American Journal of Preventive Medicine, 32(5), 419-

434.

http://www.breastcancer.org/tips/exercise/treatment

174 Bibliography

15. Australian Institute of Health and Welfare, (2018), Cancer compendium:

information and trends by cancer type: 2017. Canberra: Australian

Government (Cancer Australia). Retrieved from:

https://www.aihw.gov.au/reports/cancer/cancer-compendium-information-

trends-by-cancer/report-contents/all-cancers-combined

16. Australian Institute of Health and Welfare 2012. Cancer incidence

projections: Australia, 2011 to 2020. Canberra: Australian Institute of Health

and Welfare. Retrieved from: https://www.aihw.gov.au/getmedia/a79de4a1-

49f5-4c93-bc59-4d181430aa69/14096.pdf.aspx?inline=true

17. The Australian Institute of Health and Welfare (2015). Australian Cancer

Incidence and Mortality (ACIM) books. Canberra: Australian Government

(Cancer Australia). Retrieved from: http://www.aihw.gov.au/acim-books/.

18. Ferlay, J., Shin, H. R., Bray, F., Forman, D., Mathers, C., & Parkin, D. M.

(2010). Estimates of worldwide burden of cancer in 2008: GLOBOCAN.

International Journal of Cancer, 127(12), 2893-2917.

19. National Cancer Institute. (2015). Breast Cancer Treatment. Retrieved from:

http://www.cancer.gov/types/breast/patient/breast-treatment-pdq#section/all.

20. Breastcancer.org. (2017). Stages of Breast Cancer. 2 Retrieved from:

http://www.breastcancer.org/symptoms/diagnosis/staging?gclid=Cj0KCQiA1

afSBRD2ARIsAEvBsNnlVIJl97rOK_Xb73m1h09dNBIEYlbxGAtRpmYo2j

nyAedr4WvK3ZEaAsK3EALw_wcB.

21. Le-Petross, H. C., & Caudle, A. S. (2015). Staging of breast cancer. In Breast

Cancer Screening and Diagnosis: A Synopsis (pp. 301-374). Springer New

York. Retrieved from:

https://mdanderson.elsevierpure.com/en/publications/staging-of-breast-

cancer.

22. National Cancer Control Indicators. (2018). Capture of Stage Data: 2018,

Cancer Australia: Canberrra. Retrieved from

https://ncci.canceraustralia.gov.au/diagnosis/capture-stage-data/new-cancer-

cases-stage-diagnosis-recorded

23. National Cancer Registration and Analysis Service. (2010). Survival by stage.

National Cancer Intelligence Network: London. Retrieved from

http://www.ncin.org.uk/publications/survival_by_stage#

24. American Cancer Society. (2017). Breast Cancer Facts & Figures: 2017-2018.

Atlanta: American Cancer Society, Inc.

25. Cardoso, F., Harbeck, N., Fallowfield, L., Kyriakides, S., & Senkus, E. (2012).

Locally recurrent or metastatic breast cancer: ESMO Clinical Practice

Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 23(7),

11-19.

26. Howlader N., Noone A. M., Krapcho M., Miller D., Bishop K., & Kosary C.L.

(2016). National Cancer Institute SEER Cancer Statistics Review, 1975-2014.

Retrieved from https://seer.cancer.gov/csr/1975_2014/,

27. National Cancer Institute (2015). SEER Cancer Statistics Review: 1975-2014.

28. Breast Cancer Now., Your guide to breast cancer treatment. 2017: Breast

Cancer Now: London

29. American Cancer Society. (2017). Breast Cancer: Treating Breast Cancer.

Atlanta: American Cancer Society, Inc.

30. DiSipio, T., Hayes, S., Newman, B., & Janda, M. (2008). Health-related quality

of life 18 months after breast cancer: comparison with the general population

of Queensland, Australia. Supportive Care in Cancer, 16(10), 1141-1150.

http://www.aihw.gov.au/acim-books/

http://www.cancer.gov/types/breast/patient/breast-treatment-pdq#section/all

http://www.breastcancer.org/symptoms/diagnosis/staging?gclid=Cj0KCQiA1afSBRD2ARIsAEvBsNnlVIJl97rOK_Xb73m1h09dNBIEYlbxGAtRpmYo2jnyAedr4WvK3ZEaAsK3EALw_wcB



Bibliography 175

31. Miller, K. D., Siegel, R. L., Lin, C. C., Mariotto, A. B., Kramer, J. L., Rowland,

J. H., Jemal, A. (2016). Cancer treatment and survivorship statistics, 2016. CA:

A Cancer Journal for Clinicians, 66(4), 271-289.

32. Dixon, J. M. (2012). ABC of breast diseases (4th;4. Aufl.;4; ed.). Chichester,

West Sussex: Blackwell.

33. National Comprehensive Cancer Network, (2016). Breast cancer: National

Comprehensive Cancer Network guidelines for patients. Retrieved from:

https://www.nccn.org/patients/default.aspx.

34. Mina, L., Storniolo, A. M., Kipfer, H. D., Hunter, C., & Ludwig, K. (2016).

Breast cancer prevention and treatment (1st 2016 ed.). DE: Springer Verlag.

35. Cancer Australia (2018). Targeted therapy. Australian Government: Canberra.

Retrieved from

https://canceraustralia.gov.au/affected-cancer/treatment/targeted-therapy

36. Cancer Australia (2018). Trastuzumab (Herceptin). Australian Government:

Canberra. Retrieved from https://canceraustralia.gov.au/affected-

cancer/cancer-types/breast-cancer/treatment/what-does-treatment-breast-

cancer-involve/targeted-therapies/types-targeted-therapy/trastuzumab-

herceptin

37. Blowers, E., & Foy, S. (2009). Breast cancer overview: Current treatments.

Practice Nursing, 20(6), 282-286.

38. Kaufmann, M., von Minckwitz, G., Bergh, J., Conte, P.-F., Darby, S.,

Eiermann, W., Loibl, S. (2013). Breakthroughs in research and treatment of

early breast cancer: an overview of the last three decades. Archives of

Gynecology and Obstetrics, 288(6), 1203-1212.

39. Breastcancer.org, Treatment Options by Cancer Stage. 2017: Ardmore, PA

40. Society, A.C., Cancer Treatment and Survivorship Facts & Figures 2014-

2015. 2014, American Cancer Society, Inc: Atlanta.

41. Bower, J. E., Ganz, P. A., Desmond, K. A., Rowland, J. H., Meyerowitz, B. E.,

& Belin, T. R. (2000). Fatigue in breast cancer survivors: occurrence,

correlates, and impact on quality of life. Journal of Clinical Oncology, 18(4),

743-753.

42. Demark-Wahnefried, W., Campbell, K. L., & Hayes, S. C. (2012). Weight

management and its role in breast cancer rehabilitation. Cancer, 118(8), 2277-

2287.

43. Hayes, S. C., Johansson, K., Stout, N. L., Prosnitz, R., Armer, J. M., Gabram,

S., & Schmitz, K. H. (2012). Upper‐body morbidity after breast cancer.

Cancer, 118(8), 2237-2249.

44. Partridge, A. H., Burstein, H. J., & Winer, E. P. (2001). Side effects of

chemotherapy and combined chemohormonal therapy in women with early-

stage breast cancer. JNCI Monographs, 1(30), 135-142.

45. Truong, P. T., Olivotto, I. A., Whelan, T. J., & Levine, M. (2004). Clinical

practice guidelines for the care and treatment of breast cancer: 16.

Locoregional post-mastectomy radiotherapy. The Canadian Medical

Association Journal, 170(8), 1263-1273.

46. Yoon, J., Malin, J. L., Tao, M. L., Tisnado, D. M., Adams, J. L., Timmer, M.

J., Kahn, K. L. (2008). Symptoms after breast cancer treatment: are they

influenced by patient characteristics? Breast Cancer Research and Treatment,

108(2), 153-165.

47. Ganz, P. A., Kwan, L., Stanton, A. L., Krupnick, J. L., Rowland, J. H.,

Meyerowitz, B. E., Belin, T. R. (2004). Quality of life at the end of primary

176 Bibliography

treatment of breast cancer: first results from the moving beyond cancer

randomized trial. Journal of the National Cancer Institute, 96(5), 376-387.

48. Schmitz, K. H., DiSipio, T., Gordon, L. G., & Hayes, S. C. (2015). Adverse

breast cancer treatment effects: the economic case for making rehabilitative

programs standard of care. Supportive Care in Cancer, 23(6), 1807-1817.

49. Schmitz, K. H., Speck, R. M., Rye, S. A., DiSipio, T., & Hayes, S. C. (2012).

Prevalence of breast cancer treatment sequelae over 6 years of follow-up: the

Pulling Through Study. Cancer, 118(8 Suppl), 2217-2225.

50. Minton, O., & Stone, P. (2008). How common is fatigue in disease-free breast

cancer survivors? A systematic review of the literature. Breast Cancer


51. Berger, A. M., Gerber, L. H., & Mayer, D. K. (2012). Cancer-related fatigue:

Implications for breast cancer survivors. Cancer, 118(8), 2261-2269.

52. Goodwin, P. J., Ennis, M., Pritchard, K. I., McCready, D., Koo, J., Sidlofsky,

S., Redwood, S. (1999). Adjuvant treatment and onset of menopause predict

weight gain after breast cancer diagnosis. Journal of Clinical Oncology, 17(1),

120-129.

53. Irwin, M. L., McTiernan, A., Baumgartner, R. N., Baumgartner, K. B.,

Bernstein, L., Gilliland, F. D., & Ballard-Barbash, R. (2005). Changes in Body

Fat and Weight After a Breast Cancer Diagnosis: Influence of Demographic,

Prognostic, and Lifestyle Factors. Journal of Clinical Oncology, 23(4), 774-

782.

54. Dale, K. S., Mann, J. I., McAuley, K. A., Williams, S. M., & Farmer, V. L.

(2009). Sustainability of lifestyle changes following an intensive lifestyle

intervention in insulin resistant adults: Follow-up at 2-years. Asia Pacific

Journal of Clinical Nutrition, 18.

55. Ghose, A., Kundu, R., Toumeh, A., Hornbeck, C., & Mohamed, I. (2015). A

Review of Obesity, Insulin Resistance, and the Role of Exercise in Breast

Cancer Patients. Nutrition and Cancer, 67(2), 197-202.

56. Jones, L. W., Courneya, K. S., Mackey, J. R., Muss, H. B., Pituskin, E. N.,

Scott, J. M., Haykowsky, M. (2012). Cardiopulmonary function and age-

related decline across the breast cancer survivorship continuum. Journal of

Clinical Oncology, 30(20), 2530-2537.

57. Riebe, D., Ehrman, J. K., Liguori, G., Magal, M., & American College of

Sports Medicine. (2018). ACSM's guidelines for exercise testing and

prescription (Tenth ed.). Philadelphia, PA: Wolters Kluwer Health.

58. Schwartz, A. L., Winters-Stone, K., & Gallucci, B. (2007). Exercise effects on

bone mineral density in women with breast cancer receiving adjuvant

chemotherapy. Oncology Nursing Forum, 34(3), 627-633.

59. Winters-Stone, K. M., Dobek, J., Bennett, J. A., Nail, L. M., Leo, M. C., &

Schwartz, A. (2012). The effect of resistance training on muscle strength and

physical function in older, postmenopausal breast cancer survivors: a

randomized controlled trial. Journal of Cancer Survivorship: Research And

Practice, 6(2), 189-199.

60. Courneya, K. S., Lane, K., Yasui, Y., McKenzie, D. C., Segal, R. J., Mackey,

J. R., Vallance, J. K. H. (2007). Effects of aerobic and resistance exercise in

breast cancer patients receiving adjuvant chemotherapy: a multicenter

randomized controlled trial. Journal of Clinical Oncology, 25(28), 4396-4404.

61. Hornsby, W. E., Douglas, P. S., West, M. J., Kenjale, A. A., Lane, A. R.,

Schwitzer, E. R., Jones, L. W. (2014). Safety and efficacy of aerobic training

Bibliography 177

in operable breast cancer patients receiving neoadjuvant chemotherapy: a

phase II randomized trial. Acta Oncologica, 53(1), 65-74.

62. McMillan, E. M., & Newhouse, I. J. (2011). Exercise is an effective treatment

modality for reducing cancer-related fatigue and improving physical capacity

in cancer patients and survivors: a meta-analysis. Applied Physiology,

Nutrition, and Metabolism, 36(6), 892-903.

63. Hayes, S. C., Rye, S., Battistutta, D., DiSipio, T., & Newman, B. (2010).

Upper-body morbidity following breast cancer treatment is common, may

persist longer-term and adversely influences quality of life. Health and Quality

of Life Outcomes, 8(1), 92-92.

64. Karki, A., Simonen, R., Malkia, E., & Selfe, J. (2005). Impairments, activity

limitations and participation restrictions 6 and 12 months after breast cancer

operation. Journal of Rehabilitation Medicine, 37(3), 180-188.

65. Rietman, J. S., Dijkstra, P. U., Debreczeni, R., Geertzen, J. H. B., Robinson,

D. P. H., & de Vries, J. (2004). Impairments, disabilities and health related

quality of life after treatment for breast cancer: a follow-up study 2.7 years

after surgery. Disability and Rehabilitation, 26(2), 78-84.

66. Edwards, B. K., Noone, A. M., Mariotto, A. B., Simard, E. P., Boscoe, F. P.,

Henley, S. J., Ward, E. M. (2014). Annual Report to the Nation on the status

of cancer, 1975‐2010, featuring prevalence of comorbidity and impact on

survival among persons with lung, colorectal, breast, or prostate cancer.

Cancer, 120(9), 1290-1314.

67. Harlan, L. C., Klabunde, C. N., Ambs, A. H., Gibson, T., Bernstein, L.,

McTiernan, A., Ballard-Barbash, R. (2009). Comorbidities, therapy, and newly

diagnosed conditions for women with early stage breast cancer. Journal of

Cancer Survivorship, 3(2), 89-98.

68. Yancik, R., Wesley, M. N., Ries, L. A. G., Havlik, R. J., Edwards, B. K., &

Yates, J. W. (2001). Effect of age and comorbidity in postmenopausal breast

cancer patients aged 55 years and older. Journal of the American Medical

Association, 285(7), 885-892.

69. Leach, C. R., Weaver, K. E., Aziz, N. M., Alfano, C. M., Bellizzi, K. M., Kent,

E. E., Rowland, J. H. (2015). The complex health profile of long-term cancer

survivors: prevalence and predictors of comorbid conditions. Journal of

Cancer Survivorship, 9(2), 239-251.

70. Hooning, M. J., Botma, A., Aleman, B. M. P., Baaijens, M. H. A., Bartelink,

H., Klijn, J. G. M., van Leeuvven, F. E. (2007). Long-term risk of

cardiovascular disease in 10-year survivors of breast cancer. Journal of The

National Cancer Institute, 99(5), 365-375.

71. Clough-Gorr, K. M., Ganz, P. A., & Silliman, R. A. (2010). Older breast cancer

survivors: Factors associated with self-reported symptoms of persistent

lymphedema over 7 years of follow-up. Breast Journal, 16(2), 147-155.

72. Kwan, M. L., Ergas, I. J., Somkin, C. P., Quesenberry Jr, C. P., Neugut, A. I.,

Hershman, D. L., Kushi, L. H. (2010). Quality of life among women recently

diagnosed with invasive breast cancer: the Pathways Study. Breast Cancer


73. Weitzner, M. A., Meyers, C. A., Stuebing, K. K., & Saleeba, A. K. (1997).

Relationship between quality of life and mood in long-term survivors of breast

cancer treated with mastectomy. Supportive Care in Cancer, 5(3), 241-248.

178 Bibliography

74. Harrison, S., Hayes, S. C., & Newman, B. (2009). Level of physical activity

and characteristics associated with change following breast cancer diagnosis

and treatment. Psychooncology, 18(4), 387-394.

75. Irwin, M. L., Crumley, D., McTiernan, A., Bernstein, L., Baumgartner, R.,

Gilliland, F. D., Ballard-Barbash, R. (2003). Physical activity levels before and

after a diagnosis of breast carcinoma: the Health, Eating, Activity, and

Lifestyle (HEAL) study. Cancer, 97(7), 1746-1757.

76. Hair, B. Y., Hayes, S., Tse, C. K., Bell, M. B., & Olshan, A. F. (2014). Racial

differences in physical activity among breast cancer survivors: implications for

breast cancer care. Cancer, 120(14), 2174-2182.

77. Janz, N. K., Mujahid, M., Chung, L. K., Lantz, P. M., Hawley, S. T., Morrow,

M., Katz, S. J. (2007). Symptom experience and quality of life of women

following breast cancer treatment. Journal of Women's Health, 16(9), 1348-

1361.

78. Knobf, M. T., Musanti, R., & Dorward, J. (2007). Exercise and quality of life

outcomes in patients with cancer. Seminars in Oncology Nursing, 23(4), 285-

296.

79. Noal, S., Levy, C., Hardouin, A., Rieux, C., Heutte, N., Ségura, C., Joly, F.

(2011). One-Year Longitudinal Study of Fatigue, Cognitive Functions, and

Quality of Life After Adjuvant Radiotherapy for Breast Cancer. International

Journal of Radiation Oncology, Biology, Physics, 81(3), 795-803.

80. So, W. K. W., Marsh, G., Ling, W. M., Leung, F. Y., Lo, J. C. K., Yeung, M.,

& Li, G. K. H. (2009). The symptom cluster of fatigue, pain, anxiety, and

depression and the effect on the quality of life of women receiving treatment

for breast cancer: a multicenter study. Oncology Nursing Forum, 36(4), E205-

214.

81. Trinh, L., Amireault, S., Lacombe, J., & Sabiston, C. M. (2015). Physical and

psychological health among breast cancer survivors: interactions with

sedentary behavior and physical activity: Sedentary behavior and health in

breast cancer. Psycho-Oncology, 24(10), 1279-1285.

82. Gho, S. A., Steele, J. R., Jones, S. C., & Munro, B. J. (2013). Self-reported side

effects of breast cancer treatment: a cross-sectional study of incidence,

associations, and the influence of exercise. Cancer Causes & Control, 24(3),

517-528.

83. Speck, R. M., Courneya, K. S., Mâsse, L. C., Duval, S., & Schmitz, K. H.

(2010). An update of controlled physical activity trials in cancer survivors: a

systematic review and meta-analysis. Journal of Cancer Survivorship, 4(2),

87-100.

84. Schmitz, K. H., Holtzman, J., Courneya, K. S., Mâsse, L. C., Duval, S., &

Kane, R. (2005). Controlled Physical Activity Trials in Cancer Survivors: A

Systematic Review and Meta-analysis. Cancer Epidemiology Biomarkers &

Prevention, 14(7), 1588-1595.

85. Chung, C., Lee, S., Hwang, S., & Park, E. (2013). Systematic Review of

Exercise Effects on Health Outcomes in Women with Breast Cancer. Asian

Nursing Research, 7(3), 149-159.

86. Spence, R. R., Heesch, K. C., & Brown, W. J. (2010). Exercise and cancer

rehabilitation: a systematic review. Cancer Treatment Reviews, 36(2), 185-

194.

87. Duijts, S. F. A., Faber, M. M., Oldenburg, H. S. A., van Beurden, M., &

Aaronson, N. K. (2011). Effectiveness of behavioral techniques and physical

Bibliography 179

exercise on psychosocial functioning and health‐related quality of life in breast

cancer patients and survivors—a meta‐analysis. Psycho‐Oncology, 20(2), 115-

126.

88. Jones, L. W., Habel, L. A., Weltzien, E., Castillo, A., Gupta, D., Kroenke, C.

H., Caan, B. J. (2016). Exercise and Risk of Cardiovascular Events in Women

With Nonmetastatic Breast Cancer. Journal of Clinical Oncology, 34(23),

2743-2743.

89. Irwin, M. L. (2009). Physical activity interventions for cancer survivors.

British Journal of Sports Medicine, 43(1), 32-38.

90. Ibrahim, E. M., & Al-Homaidh, A. (2011). Physical activity and survival after

breast cancer diagnosis: meta-analysis of published studies. Medical Oncology,

28(3), 753-765.

91. Ballard-Barbash, R., Friedenreich, C. M., Courneya, K. S., Siddiqi, S. M.,

McTiernan, A., & Alfano, C. M. (2012). Physical activity, biomarkers, and

disease outcomes in cancer survivors: a systematic review. Journal of the


92. Cormie, P., Zopf, E. M., Zhang, X., & Schmitz, K. H. (2017). The Impact of

Exercise on Cancer Mortality, Recurrence, and Treatment-Related Adverse

Effects. Epidemiologic Reviews, 39(1):71-92.

93. Courneya, K. S., Segal, R. J., McKenzie, D. C., Dong, H., Gelmon, K.,

Friedenreich, C. M., Mackey, J. R. (2014). Effects of exercise during adjuvant

chemotherapy on breast cancer outcomes. Medicine & Science in Sports &

Exercise, 46(9), 1744-1751.

94. Hayes, S. C., Steele, M., Spence, R., Pyke, C., Saunders, C., Bashford, J., &

Eakin, E. (2017). Can exercise influence survival following breast cancer:

Results from a randomised, controlled trial. Journal of Clinical Oncology,

35(15), 10067-10067.

95. Maher, C. G., Sherrington, C., Herbert, R. D., Moseley, A. M., & Elkins, M.

(2003). Reliability of the PEDro Scale for Rating Quality of Randomized

Controlled Trials. Physical Therapy, 83(8), 713-721.

96. Sherrington, C., Herbert, R. D., Maher, C. G., & Moseley, A. M. (2000).

PEDro. A database of randomized trials and systematic reviews in

physiotherapy. Manual Therapy, 5(4), 223-226.

97. National Institutes of Health, N.C.I., Common Terminology Criteria for

Adverse Events (CTCAE). 2009.

98. Cheema, B., Gaul, C. A., Lane, K., & Fiatarone Singh, M. A. (2008).

Progressive resistance training in breast cancer: a systematic review of clinical

trials. Breast Cancer Research and Treatment, 109(1), 9-26.

99. Tian, L., Lu, H. J., Lin, L., & Hu, Y. (2016). Effects of aerobic exercise on

cancer-related fatigue: a meta-analysis of randomized controlled trials.

Supportive Care in Cancer, 24(2), 969-983.

100. Zeng, Y., Huang, M., Cheng, A. S., Zhou, Y., & So, W. K. (2014). Meta-

analysis of the effects of exercise intervention on quality of life in breast cancer

survivors. Breast Cancer, 21(3), 262-274.

101. Lipsett, A., Barrett, S., Haruna, F., Mustian, K., & O'Donovan, A. (2017). The

impact of exercise during adjuvant radiotherapy for breast cancer on fatigue

and quality of life: A systematic review and meta-analysis. Breast (Edinburgh,

Scotland), 32, 144-155.

102. Carayol, M., Bernard, P., Boiché, J., Riou, F., Mercier, B., Cousson-Gélie, F.,

Ninot, G. (2013). Psychological effect of exercise in women with breast cancer

180 Bibliography

receiving adjuvant therapy: what is the optimal dose needed? Annals of

Oncology, 24(2), 291-300.

103. Juvet, L. K., Thune, I., Elvsaas, I. K. O., Fors, E. A., Lundgren, S., Bertheussen,

G., Oldervoll, L. M. (2017). The effect of exercise on fatigue and physical

functioning in breast cancer patients during and after treatment and at 6 months

follow-up: A meta-analysis. Breast, 33, 166-177.

104. van Vulpen, J. K., Peeters, P. H., Velthuis, M. J., van der Wall, E., & May, A.

M. (2016). Effects of physical exercise during adjuvant breast cancer treatment

on physical and psychosocial dimensions of cancer-related fatigue: A meta-

analysis. Maturitas, 85, 104-111.

105. Kim, C., Kang, D., & Park, J. (2009). A meta-analysis of aerobic exercise

interventions for women with breast cancer. Western Journal of Nursing

Research, 31(4), 437-461.

106. Glasgow, R. E., Goldstein, M. G., Ockene, J. K., & Pronk, N. P. (2004).

Translating what we have learned into practice. Principles and hypotheses for

interventions addressing multiple behaviors in primary care. American Journal

of Preventive Medicine, (2 Suppl), 88-101.

107. Spark, L. C., Reeves, M. M., Fjeldsoe, B. S., & Eakin, E. G. (2013). Physical

activity and/or dietary interventions in breast cancer survivors: a systematic

review of the maintenance of outcomes. The Journal of Cancer Survivorship,

7(1), 74-82.

108. Bluethmann, S. M., Vernon, S. W., Gabriel, K. P., Murphy, C. C., &

Bartholomew, L. K. (2015). Taking the next step: a systematic review and

meta-analysis of physical activity and behavior change interventions in recent

post-treatment breast cancer survivors. Breast Cancer Research and

Treatment, 149(2), 331-342.

109. Gordon, L. G., DiSipio, T., Battistutta, D., Yates, P., Bashford, J., Pyke, C.,

Hayes, S. C. (2016). Cost-effectiveness of a pragmatic exercise intervention

for women with breast cancer: results from a randomized controlled trial.

Psychooncology, 26(5):649-655.

110. Yellen, S. B., Cella, D. F., Webster, K., Blendowski, C., & Kaplan, E. (1997).

Measuring fatigue and other anemia-related symptoms with the Functional

Assessment of Cancer Therapy (FACT) measurement system. Journal of Pain

and Symptom Management, 13(2), 63-74.

111. Swain, D. P., Brawner, C. A., & American College of Sports, M. (2014).

ACSM's resource manual for Guidelines for exercise testing and prescription

(Vol. Seventhition.). Philadelphia: Wolters Kluwer Health/Lippincott

Williams & Wilkins.

112. Australian Government, Australia's Physical Activity and Sedentary Behaviour

Guidelines Department of Health, Editor. 2012: Canberra, ACT. p. 2.

Retrieved from http://www.health.gov.au/paguidelines#apaadult.

113. Ligibel, J. A., Giobbie‐Hurder, A., Shockro, L., Campbell, N., Partridge, A. H.,

Tolaney, S. M., Winer, E. P. (2016). Randomized trial of a physical activity

intervention in women with metastatic breast cancer. Cancer, 122(8), 1169-

1177.

114. Borg, G. (1970). Perceived exertion as an indicator of somatic stress.

Scandinavian Journal Of Rehabilitation Medicine, 2(2), 92-98.

115. Exercise and Sport Science Australia (2014). Accredited Exercise Physiologist

Scope of Practice. Retrieved from https://www.essa.org.au/wp-

content/uploads/2011/08/AEP-Scope-of-Practice_-Final-September-2014.pdf

Bibliography 181

116. Soan, E. J., Street, S. J., Brownie, S. M., & Hills, A. P. (2014). Exercise

physiologists: essential players in interdisciplinary teams for

noncommunicable chronic disease management. Journal Of Multidisciplinary

Healthcare. 7(3):65-68.

117. Dattalo, M., Giovannetti, E. R., Scharfstein, D., Boult, C., Wegener, S., Wolff,

J. L., Boyd, C. (2012). Who Participates in Chronic Disease Self-Management

(CDSM) Programs? Differences between Participants and Non-Participants in

a Population of Multi-Morbid Older Adults. Medical Care, 50(12), 1071-1075.

118. Eakin, E. G., Reeves, M. M., Lawler, S. P., Oldenburg, B., Del Mar, C., Wilkie,

K., Graves, N. (2008). The Logan Healthy Living Program: A cluster

randomized trial of a telephone-delivered physical activity and dietary

behavior intervention for primary care patients with type 2 diabetes or

hypertension from a socially disadvantaged community — Rationale, design

and recruitment. Contemporary Clinical Trials, 29(3), 439-454.

119. Fleury, J., & Lee, S. M. (2006). The Social Ecological Model and Physical

Activity in African American Women. American Journal of Community

Psychology, 37(1), 129.

120. Australian Government Department of Health and Ageing. (2006), The

Australian Clinical Trial Handbook. A simple, practical guide to the to the

conduct of clinical trials to International standards of Good Clinical Practice

(GCP) in the Australian context. Commonwealth of Australia: Canberra.

Retrieved from http://www.tga.gov.au/sites/default/files/clinical-trials-

handbook.pdf.

121. Newton, M. J., Hayes, S. C., Janda, M., Webb, P. M., Obermair, A., Eakin, E.

G., Beesley, V. L. (2011). Safety, feasibility and effects of an individualised

walking intervention for women undergoing chemotherapy for ovarian cancer:

A pilot study. BMC Cancer, 11(1), 389-389.

122. Coats, V., Maltais, F., Simard, S., Fréchette, É., Tremblay, L., Ribeiro, F., &

Saey, D. (2013). Feasibility and effectiveness of a home-based exercise

training program before lung resection surgery. Canadian Respiratory

Journal, 20(2), e10-e16. Retrieved from

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3630051/

123. American Thoracic Society. (2002). American Thoracic Society statement:

guidelines for the six-minute walk test. American Journal of Respiratory and

Critical Care Medicine, 166(1): p. 111-7.

124. Galiano-Castillo, N., Arroyo-Morales, M., Ariza-Garcia, A., Sanchez-Salado,

C., Fernandez-Lao, C., Cantarero-Villanueva, I., & Martin-Martin, L. (2016).

The Six-Minute Walk Test as a Measure of Health in Breast Cancer Patients.

Journal of Aging and Physical Activity, 24(4), 508-515.

125. ATS Committee on Proficiency Standards for Clinical Pulmonary Function

Laboratories. (2002). ATS statement: guidelines for the six-minute walk test.

American Journal of Respiratory and Critical Care Medicine, 166(1), 111-

117.

126. Bernstein, M. L., Despars, J. A., Singh, N. P., Avalos, K., Stansbury, D. W., &

Light, R. W. (1994). Reanalysis of the 12-minute walk in patients with chronic

obstructive pulmonary disease. Chest, 105(1), 163-167.

127. American College of Sports Medicine. (2009). American College of Sports

Medicine position stand. Progression models in resistance training for healthy

adults. Medicine & Science in Sports & Exercise, 41(3), 687.

182 Bibliography

128. Musanti, R. (2012). A study of exercise modality and physical self-esteem in

breast cancer survivors. Medicine & Science in Sports & Exercise, 44(2), 352-

361.

129. Zak, M., Biskup, M., Macek, P., Krol, H., Krupnik, S., & Opuchlik, A. (2017).

Identifying predictive motor factors for falls in post-menopausal breast cancer

survivors. PLoS One, 12(3), e0173970.

130. Jones, C. J., Rikli, R. E., & Beam, W. C. (1999). A 30-s Chair-Stand Test as a

Measure of Lower Body Strength in Community-Residing Older Adults.

Research Quarterly for Exercise and Sport, 70(2), 113-119.

131. Oldervoll, L. M., Loge, J. H., Lydersen, S., Paltiel, H., Asp, M. B., Nygaard,

U. V., Kaasa, S. (2011). Physical Exercise for Cancer Patients with Advanced

Disease: A Randomized Controlled Trial. Oncologist, 16(11), 1649-1657.

132. Buchan, J., Janda, M., Box, R., Schmitz, K., & Hayes, S. (2016). A

Randomized Trial on the Effect of Exercise Mode on Breast Cancer-Related

Lymphedema. Medicine & Science in Sports & Exercise, 48(10), 1866-1874.

133. Sherrington, C., & Lord, S. R. (2005). Reliability of simple portable tests of

physical performance in older people after hip fracture. Clinical Rehabilitation,

19(5), 496-504.

134. Ward, L. C. (2006). Bioelectrical impedance analysis: proven utility in

lymphedema risk assessment and therapeutic monitoring. Lymphatic Research

And Biology, 4(1), 51-56.

135. Ward, L. C., Dylke, E., Czerniec, S., Isenring, E., & Kilbreath, S. L. (2011).

Confirmation of the reference impedance ratios used for assessment of breast

cancer-related lymphedema by bioelectrical impedance spectroscopy.

Lymphatic Research and Biology, 9(1), 47-51.

136. Cella, D. F., Tulsky, D. S., Gray, G., Sarafian, B., Linn, E., Bonomi, A., et al.

(1993). The Functional Assessment of Cancer Therapy scale: development and

validation of the general measure. Journal of Clinical Oncology, 11(3), 570-

579.

137. Cheifetz, O., Park Dorsay, J., Hladysh, G., Macdermid, J., Serediuk, F., &

Woodhouse, L. J. (2014). CanWell: meeting the psychosocial and exercise

needs of cancer survivors by translating evidence into practice. Psycho‐Oncology, 23(2), 204-215.

138. Jensen, R. E., Potosky, A. L., Reeve, B. B., Hahn, E., Cella, D., Fries, J.,

Moinpour, C. M. (2015). Validation of the PROMIS physical function

measures in a diverse US population-based cohort of cancer patients.(Report).

Quality of Life Research, 24(10), 2333.

139. Badger, T. A., Heitkemper, M., Lee, K. A., & Bruner, D. W. (2014). An

experience with the Patient-Reported Outcomes Measurement Information

System: Pros and cons and unanswered questions. Nursing Outlook, 62(5),

332-338.

140. Cella, D., Riley, W., Stone, A., Rothrock, N., Reeve, B., Yount, S., Hays, R.

(2010a). Initial Adult Health Item Banks and First Wave Testing of the Patient-

Reported Outcomes Measurement Information System (PROMIS™))

Network: 2005–2008. Journal of Clinical Epidemiology, 63(11), 1179-1194.

141. Schwarzer, R. (2005). Health-Specific Self-Efficacy Scales Self-Efficacy

Scale. Retrieved from https://userpage.fu-berlin.de/health/healself.pdf

142. Marcus, B. H., Selby, V. C., Niaura, R. S., & Rossi, J. S. (1992). Self-Efficacy

and the Stages of Exercise Behavior Change. Research Quarterly for Exercise

and Sport, 63(1), 60-66.

Bibliography 183

143. Rogers, L. Q., Courneya, K. S., Verhulst, S., Markwell, S., Lanzotti, V., &

Shah, P. (2006). Exercise barrier and task self-efficacy in breast cancer patients

during treatment. Supportive Care in Cancer, 14(1), 84-90.

144. Brown, W. J., Burton, N. W., Marshall, A. L., & Miller, Y. D. (2008).

Reliability and validity of a modified self-administered version of the Active

Australia physical activity survey in a sample of mid-age women. Australian

and New Zealand Journal of Public Health, 32(6), 535-541.

145. Australian Institute of Health and Welfare. (2004). The Active Australia

Survey: A Guide and Manual for Implementation, Analysis and Reporting.

Australian Institute of Health and Welfare, Australian Govenment: Canberra.

146. Australian Institute of Health and Welfare. (2003). The active Australia survey.

A guide for manual implementation, analysis and reporting. Australian

Institute of Health and Welfare, Australian Govenment: Canberra.

147. Alley, S., Schoeppe, S., Guertler, D., Jennings, C., Duncan, M. J., &

Vandelanotte, C. (2016). Interest and preferences for using advanced physical

activity tracking devices: results of a national cross-sectional survey. BMJ

Open, 6(7), e011243.

148. Fjeldsoe, B. S., Winkler, E. A., Marshall, A. L., Eakin, E. G., & Reeves, M. M.

(2013). Active adults recall their physical activity differently to less active

adults: test-retest reliability and validity of a physical activity survey. Health

Promotion Journal of Australia, 24(1), 26-31.

149. Kim, S. P., Mayhew, L. J., & Peterson, F. D. (2002). A Modified YMCA Bench

Press Test as a Predictor of 1 Repetition Maximum Bench Press Strength.

Journal of Strength and Conditioning Research, 16(3), 440-445.

150. Coster, S., K. Poole, and L.J. Fallowfield. (2001). The validation of a quality

of life scale to assess the impact of arm morbidity in breast cancer patients

post-operatively. Breast Cancer Research and Treatment, 68(3): p. 273-82.

151. Brady, M. J., Cella, D. F., Mo, F., Bonomi, A. E., Tulsky, D. S., Lloyd, S. R.,

Shiomoto, G. (1997). Reliability and validity of the Functional Assessment of

Cancer Therapy-Breast quality-of-life instrument. Journal of Clinical

Oncology, 15(3), 974-986.

152. Cella, D., Riley, W., Stone, A., Rothrock, N., Reeve, B., Yount, S., Hays, R.

(2010b). The Patient-Reported Outcomes Measurement Information System

(PROMIS) developed and tested its first wave of adult self-reported health

outcome item banks: 2005-2008. Journal of Clinical Epidemiology, 63(11),

1179-1194.

153. Hays, R. D., Bjorner, J. B., Revicki, D. A., Spritzer, K. L., & Cella, D. (2009).

Development of physical and mental health summary scores from the patient-

reported outcomes measurement information system (PROMIS) global items.

Quality of Life Research, 18(7), 873.

154. Bennett, A., Reeve, B., Basch, E., Mitchell, S., Meeneghan, M., Battaglini, C.,

Wood, W. (2016). Evaluation of pedometry as a patient-centered outcome in

patients undergoing hematopoietic cell transplant (HCT): a comparison of

pedometry and patient reports of symptoms, health, and quality of life. Quality

of Life Research, 25(3), 535-546.

155. Turk, D. C., Fillingim, R. B., Ohrbach, R., & Patel, K. V. (2016). Assessment

of Psychosocial and Functional Impact of Chronic Pain. Journal of Pain, 17(9),

21-49.

156. Department of Health (2016). National physical activity guidelines.

Australian Government: Canberra. Retrieved from:

184 Bibliography

http://www.health.gov.au/internet/main/publishing.nsf/content/health-

pubhlth-strateg-phys-act-guidelines#apaadult

157. Lancaster, G. A., Dodd, S., & Williamson, P. R. (2004). Design and analysis

of pilot studies: recommendations for good practice. Journal of Evaluation in

Clinical Practice, 10(2), 307-312.

158. Tsianakas, V., Harris, J., Ream, E., Van Hemelrijck, M., Purushotham, A.,

Mucci, L., Armes, J. (2017). CanWalk: a feasibility study with embedded

randomised controlled trial pilot of a walking intervention for people with

recurrent or metastatic cancer. BMJ Open, 7(2), e013719.

159. De Jesus, S., Fitzgeorge, L., Unsworth, K., Massel, D., Suskin, N., Prapavessis,

H., & Sanatani, M. (2017). Feasibility of an exercise intervention for fatigued

breast cancer patients at a community-based cardiac rehabilitation program.

Cancer Management And Research, 9, 29-39.

160. Batsis, J. A., Naslund, J. A., Gill, L. E., Masutani, R. K., Agarwal, N., &

Bartels, S. J. (2016). Use of a Wearable Activity Device in Rural Older Obese

Adults: A Pilot Study. Gerontology and Geriatric Medicine, 2:

2333721416678076.

161. Battaglini, C., Bottaro, M., Dennehy, C., Rae, L., Shields, E., Kirk, D., &

Hackney, A. C. (2007). The effects of an individualized exercise intervention

on body composition in breast cancer patients undergoing treatment. Sao Paulo

Medical Journal, 125(1), 22-28. Retrieved from

http://www.scielo.br/pdf/spmj/v125n1/a05v1251.pdf

162. Payne, J. K., Held, J., Thorpe, J., & Shaw, H. (2008). Effect of Exercise on

Biomarkers, Fatigue, Sleep Disturbances, and Depressive Symptoms in Older

Women With Breast Cancer Receiving Hormonal Therapy. Oncology Nursing

Forum, 35(4), 635-642.

163. Zhang, X., McClean, D., Ko, E., Morgan, M. A., & Schmitz, K. (2017).

Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-

Test Exploratory Pilot Study. Oncology Nursing Forum, 44(3), 366-374.

164. Holland, A. E., Hill, C. J., Rasekaba, T., Lee, A., Naughton, M. T., &

McDonald, C. F. (2010). Updating the minimal important difference for six-

minute walk distance in patients with chronic obstructive pulmonary disease.

Archives of Physical Medicine and Rehabilitation, 91(2), 221-225.

165. Kirkham, A. A., Bland, K. A., Sayyari, S., Campbell, K. L., & Davis, M. K.

2016). Clinically Relevant Physical Benefits of Exercise Interventions in

Breast Cancer Survivors. Current Oncology Reports, 18(2), 12.

166. Demark-Wahnefried, W., Peterson, B. L., Winer, E. P., Marks, L., Aziz, N.,

Marcom, P. K., Rimer, B. K. (2001). Changes in weight, body composition,

and factors influencing energy balance among premenopausal breast cancer

patients receiving adjuvant chemotherapy. Journal of Clinical Oncology,

19(9), 2381-2389.

167. Vagenas, D., Disipio, T., Battistutta, D., Demark-Wahnefried, W., Rye, S.,

Bashford, J., Hayes, S. C. (2015). Weight and weight change following breast

cancer: evidence from a prospective, population-based, breast cancer cohort

study. BMC Cancer, 15, 28.

168. Holmes, M. D., Chen, W. Y., Feskanich, D., Kroenke, C. H., & Colditz, G. A.

(2005). Physical Activity and Survival After Breast Cancer Diagnosis. The

Journal of the American Medical Association, 293(20), 2479-2486.

169. Rogers, L., Courneya, K., Anton, P., Hopkins-Price, P., Verhulst, S., Vicari,

S., McAuley, E. (2015). Effects of the BEAT Cancer physical activity behavior

Bibliography 185

change intervention on physical activity, aerobic fitness, and quality of life in

breast cancer survivors: a multicenter randomized controlled trial. Breast

Cancer Research and Treatment, 149(1), 109-119.

170. Van Den Dungen, I. A., Verhagen, C. A., van Der Graaf, W. T., van Den Berg,

J.-P., Vissers, K. C., & Engels, Y. (2014). Feasibility and Impact of a Physical

Exercise Program in Patients with Advanced Cancer: A Pilot Study. Journal of

Palliative Medicine, 17(10), 191-1098.

171. Albrecht, T. A., & Taylor, A. G. (2012). Physical activity in patients with

advanced-stage cancer: a systematic review of the literature. Clinical Journal

of Oncology Nursing, 16(3), 293-300.

172. Lowe, S. S., Watanabe, S. M., Baracos, V. E., & Courneya, K. S. (2013).

Home-based functional walking program for advanced cancer patients

receiving palliative care: a case series. BMC Palliative Care, 12, 22-22.

173. Daley, A. J., Crank, H., Saxton, J. M., Mutrie, N., Coleman, R., & Roalfe, A.

(2007). Randomized trial of exercise therapy in women treated for breast

cancer. Journal of Clinical Oncology, 25(13), 1713-1721.

174. Hayes, S., Rye, S., Battistutta, D., Yates, P., Pyke, C., Bashford, J., & Eakin,

E. (2011). Design and implementation of the Exercise for Health trial -- a

pragmatic exercise intervention for women with breast cancer. Contemporary

Clinical Trials, 32(4), 577-585.

175. Courneya, K. S., McKenzie, D. C., Mackey, J. R., Gelmon, K., Friedenreich,

C. M., Yasui, Y., Segal, R. J. (2013). Effects of exercise dose and type during

breast cancer chemotherapy: multicenter randomized trial. Journal of the


176. van Waart, H., Stuiver, M. M., van Harten, W. H., Geleijn, E., Kieffer, J. M.,

Buffart, L. M., Aaronson, N. K. (2015). Effect of Low-Intensity Physical

Activity and Moderate- to High-Intensity Physical Exercise During Adjuvant

Chemotherapy on Physical Fitness, Fatigue, and Chemotherapy Completion

Rates: Results of the PACES Randomized Clinical Trial. Journal of Clinical

Oncology, 33(17), 1918-1927.

177. Campbell, A., Mutrie, N., White, F., McGuire, F., & Kearney, N. (2005). A

pilot study of a supervised group exercise programme as a rehabilitation

treatment for women with breast cancer receiving adjuvant treatment.

European Journal of Oncology Nursing, 9(1), 56-63.

178. Kim, C., Kang, D., Smith, B. A., & Landers, K. A. (2006). Cardiopulmonary

responses and adherence to exercise in women newly diagnosed with breast

cancer undergoing adjuvant therapy. Cancer Nursing, 29(2), 156-165.

179. Travier, N., Velthuis, M. J., Steins Bisschop, C. N., van den Buijs, B.,

Monninkhof, E. M., Backx, F., May, A. M. (2015). Effects of an 18-week

exercise programme started early during breast cancer treatment: a randomised

controlled trial. BMC Medicine, 13, 121-133.

180. Wang, Y. J., Boehmke, M., Wu, Y. W., Dickerson, S. S., & Fisher, N. (2011).

Effects of a 6-week walking program on Taiwanese women newly diagnosed

with early-stage breast cancer. Cancer Nursing, 34(2), E1-13.

181. Yuen, H. K., & Sword, D. (2007). Home-based exercise to alleviate fatigue and

improve functional capacity among breast cancer survivors. Journal Of Allied

Health, 36(4), e257-e275.

182. Milne, H. M., Wallman, K. E., Gordon, S., & Courneya, K. S. (2008). Effects

of a combined aerobic and resistance exercise program in breast cancer

186 Bibliography

survivors: a randomized controlled trial. Breast Cancer Research and

Treatment, 108(2), 279-288.

183. Kirkham, A. A., Bonsignore, A., Bland, K. A., McKenzie, D. C., Gelmon, K.

A., Van Patten, C. L., & Campbell, K. L. (2017). Exercise Prescription and

Adherence for Breast Cancer: One Size Does Not FITT All. Medicine &

Science in Sports & Exercise, 50(2), 177-186.

184. Knobf, M. T., Insogna, K., DiPietro, L., Fennie, C., & Thompson, A. S. (2008).

An aerobic weight-loaded pilot exercise intervention for breast cancer

survivors: bone remodeling and body composition outcomes. Biological

Research for Nursing, 10(1), 34-43.

185. Headley, J. A., Ownby, K. K., & John, L. D. (2004). The effect of seated

exercise on fatigue and quality of life in women with advanced breast cancer.

Oncology Nursing Forum, 31(5), 977-983.

186. Soares Falcetta, F., de Araujo Vianna Trasel, H., de Almeida, F. K., Rangel

Ribeiro Falcetta, M., Falavigna, M., & Dornelles Rosa, D. (2018). Effects of

physical exercise after treatment of early breast cancer: systematic review and

meta-analysis. Breast Cancer Research and Treatment, 170(3):455-476.

187. Zhu, G., Zhang, X., Wang, Y., Xiong, H., Zhao, Y., & Sun, F. (2016). Effects

of exercise intervention in breast cancer survivors: a meta-analysis of 33

randomized controlled trails. Oncotargets and Therapy, 13(9), 2153-2168.

188. Mutrie, N., Campbell, A. M., Whyte, F., McConnachie, A., Emslie, C., Lee,

L., Ritchie, D. (2007). Benefits of supervised group exercise programme for

women being treated for early stage breast cancer: pragmatic randomised

controlled trial. British Medical Journal, 334(7592), 517-524.

189. Rajotte, E. J., Yi, J. C., Baker, K. S., Gregerson, L., Leiserowitz, A., & Syrjala,

K. L. (2012). Community-based exercise program effectiveness and safety for

cancer survivors. Journal of Cancer Survivorship, 6(2), 219-228.

190. Demark-Wahnefried, W., Case, L. D., Blackwell, K., Marcom, P. K., Kraus,

W., Aziz, N., Shaw, E. (2008). Results of a diet/exercise feasibility trial to

prevent adverse body composition change in breast cancer patients on adjuvant

chemotherapy. Clinical Breast Cancer, 8(1), 70-79.

191. Demark-Wahnefried, W., Morey, M. C., Clipp, E. C., Snyder, D. C., Sloane,

R., Pieper, C. F., & Cohen, H. J. (2005). Results of Project LEAD (Leading the

Way in Exercise and Diet) - A trial testing an intervention of telephone-

counseling and mailed materials in improving physical functioning among

older breast and prostate cancer survivors. Journal of Clinical Oncology,

23(16), 8138-8138.

192. Stull, V. B., Snyder, D. C., & Demark-Wahnefried, W. (2007). Lifestyle

interventions in cancer survivors: Designing programs that meet the needs of

this vulnerable and growing population. Journal of Nutrition, 137(1), 243S-

248S.. 137(1): p. 243S-248S.

193. Glasgow, R. E., McKay, H. G., Piette, J. D., & Reynolds, K. D. (2001). The

RE-AIM framework for evaluating interventions: what can it tell us about

approaches to chronic illness management? Patient Education and Counseling,

44(2), 119-127.

194. Glasgow, R. E., & Emmons, K. M. (2007). How can we increase translation of

research into practice? Types of evidence needed. Annual Review of Public

Health, 28, 413-433.

195. Haskell, W. L., Lee, I. M., Pate, R. R., Powell, K. E., Blair, S. N., Franklin, B.

A., Bauman, A. (2007). Physical activity and public health: updated

Bibliography 187

recommendation for adults from the American College of Sports Medicine and

the American Heart Association. Medicine & Science in Sports & Exercise,

39(8), 1423-1434.

196. Michie, S., Richardson, M., Johnston, M., Abraham, C., Francis, J., Hardeman,

W., Wood, C. E. (2013). The Behavior Change Technique Taxonomy (v1) of

93 Hierarchically Clustered Techniques: Building an International Consensus

for the Reporting of Behavior Change Interventions. Annals of Behavioral

Medicine, 46(1), 81-95.

197. National Institute for Health and Care Excellence Behaviour change:

individual approaches. 2014; Available from:

https://www.nice.org.uk/guidance/ph49/resources/behaviour-change-

individual-approaches-pdf-1996366337989

198. Kuijpers, W., Groen, W. G., Aaronson, N. K., & Harten, v. W. H. (2013). A

Systematic Review of Web-Based Interventions for Patient Empowerment and

Physical Activity in Chronic Diseases: Relevance for Cancer Survivors.

Journal of Medical Internet Research, 15(2), e37-89.

199. Groen, W. G., Kuijpers, W., Oldenburg, H. S. A., Wouters, M. W. J. M.,

Aaronson, N. K., & Harten, v. W. H. (2015). Empowerment of Cancer

Survivors Through Information Technology: An Integrative Review. Journal

of Medical Internet Research, 17(11), E270.

200. Bluethmann, S. M., Bartholomew, L. K., Murphy, C. C., & Vernon, S. W.

(2017). Use of Theory in Behavior Change Interventions: An Analysis of

Programs to Increase Physical Activity in Posttreatment Breast Cancer

Survivors. Health Education & Behavior, 44(2), 245-253.

201. Jones, L. W., Courneya, K. S., Fairey, A. S., & Mackey, J. R. (2004). Effects

of an Oncologist's Recommendation to Exercise on Self-Reported Exercise

Behavior in Newly Diagnosed Breast Cancer Survivors: A Single-Blind,

Randomized Controlled Trial. Annals of Behavioral Medicine, 28(2), 105-113.

202. Bourke, L., Homer, K. E., Thaha, M. A., Steed, L., Rosario, D. J., Robb, K. A.,

Taylor, S. J. C. (2013). Interventions for promoting habitual exercise in people

living with and beyond cancer. Cochrane Database Of Systematic Reviews,

9(9), CD010192.

203. Vallance, J., Plotnikoff, R. C., Karvinen, K. H., Mackey, J. R., & Courneya, K.

S. (2010). Understanding Physical Activity Maintenance in Breast Cancer

Survivors. American Journal Of Health Behavior, 34(2), 225-236.

204. Bandura, A. (1986). Social foundations of thought and action : a social

cognitive theory. Englewood Cliffs, N.J.: Prentice-Hall.

205. Bandura, A. (2001). Social Cognitive Theory: An Agentic Perspective. Annual

Review of Psychology, 52(1), 1-26.

206. Bandura, A. (2004). Health Promotion by Social Cognitive Means. Health

Education & Behavior, 31(2), 143-164.

207. Rogers, L. Q., Matevey, C., Hopkins-Price, P., Shah, P., Dunnington, G., &

Courneya, K. S. (2004). Exploring social cognitive theory constructs for

promoting exercise among breast cancer patients. Cancer Nursing, 27(6), 462-

473.

208. Pinto, B. M., & Ciccolo, J. T. (2011). Physical activity motivation and cancer

survivorship. Recent Results in Cancer Research, 186, 367-387.

209. Chase, J.A. (2013). Physical Activity Interventions Among Older Adults: A

Literature Review. Research and Theory for Nursing Practice, 27(1), 53-80.

https://www.nice.org.uk/guidance/ph49/resources/behaviour-change-individual-approaches-pdf-1996366337989

https://www.nice.org.uk/guidance/ph49/resources/behaviour-change-individual-approaches-pdf-1996366337989

188 Bibliography

210. Pinto, B. M., Frierson, G. M., Rabin, C., Trunzo, J. J., & Marcus, B. H. (2005).

Home-based physical activity intervention for breast cancer patients. Journal

of Clinical Oncology, 23(15), 3577-3587.

211. Matthews, C. E., Wilcox, S., Hanby, C. L., Der Ananian, C., Heiney, S. P.,

Gebretsadik, T., & Shintani, A. (2007). Evaluation of a 12-week home-based

walking intervention for breast cancer survivors. Support Care Cancer, 15(2),

203-211.

212. Demark-Wahnefried, W., Clipp, E. C., Morey, M. C., Pieper, C. F., Sloane, R.,

Snyder, D. C., & Cohen, H. J. (2006). Lifestyle intervention development study

to improve physical function in older adults with cancer: outcomes from

Project LEAD. Journal of Clinical Oncology, 24(21), 3465-3473.

213. Stacey, F. G., James, E. L., Chapman, K., Courneya, K. S., & Lubans, D. R.

(2015). A systematic review and meta-analysis of social cognitive theory-

based physical activity and/or nutrition behavior change interventions for

cancer survivors. Journal of Cancer Survivorship, 9(2), 305-338.

214. Prochaska, J. O. (2008). Decision making in the transtheoretical model of

behavior change. Medical Decision Making, 28(6), 845-849.

215. Prochaska, J. O., & DiClemente, C. C. (1983). Stages and processes of self-

change of smoking: toward an integrative model of change. Journal of

Consulting and Clinical Psychology, 51(3), 390-395.

216. Prochaska, J. O., & Velicer, W. F. (1997). The Transtheoretical Model of

Health Behavior Change. American Journal of Health Promotion, 12(1), 38-

48.

217. Marcus, B. H., Rossi, J. S., Selby, V. C., Niaura, R. S., & Abrams, D. B. (1992).

The stages and processes of exercise adoption and maintenance in a worksite

sample. Health Psychology, 11(6), 386-395.

218. Lewis, B. A., Marcus, B. H., Pate, R. R., & Dunn, A. L. (2002). Psychosocial

mediators of physical activity behavior among adults and children. American

Journal of Preventive Medicine, 23(2 Suppl), 26-35.

219. Marshall, S. J., & Biddle, S. J. (2001). The transtheoretical model of behavior

change: a meta-analysis of applications to physical activity and exercise.

Annals of Behavioral Medicine, 23(4), 229-246.

220. Scruggs, S., Mama, S. K., Carmack, C. L., Douglas, T., Diamond, P., & Basen-

Engquist, K. (2018). Randomized Trial of a Lifestyle Physical Activity

Intervention for Breast Cancer Survivors: Effects on Transtheoretical Model

Variables. Health Promotion Practice, 19(1), 134-144.

221. Pinto, B. M., Rabin, C., Papandonatos, G. D., Frierson, G. M., Trunzo, J. J., &

Marcus, B. (2008). Maintenance of Effects of a Home-Based Physical Activity

Program among Breast Cancer Survivors. Supportive Care in Cancer, 16(11),

1279-1289.

222. Loprinzi, P. D., Cardinal, B. J., Si, Q., Bennett, J. A., & Winters-Stone, K.

(2012). Theory-Based Predictors of Follow-Up Exercise Behavior After A

Supervised Exercise Intervention in Older Breast Cancer Survivors. Supportive

Care in Cancer, 20(10), 2511-2521.

223. Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior &

Human Decision Processes, 50(2), 179-211.

224. Ajzen, I. (2011). The theory of planned behaviour: reactions and reflections.

Psychology & Health, 26(9), 1113-1127.

225. Courneya, K. S., Friedenreich, C. M., Sela, R. A., Quinney, H. A., & Rhodes,

R. E. (2002). Correlates of adherence and contamination in a randomized

Bibliography 189

controlled trial of exercise in cancer survivors: An application of the theory of

planned behavior and the five factor model of personality. Annals of

Behavioral Medicine, 24(4), 257-268.

226. Smith-Turchyn, J., & Richardson, J. (2015). A Critical Review of the Theory

of Planned Behaviour to Predict and Explain Exercise Behaviour in Women

with Breast Cancer. Critical Reviews in Physical and Rehabilitation Medicine,

26(9), 1113-27.

227. Westaby, J. D. (2005). Behavioral reasoning theory: Identifying new linkages

underlying intentions and behavior. Organizational Behavior and Human

Decision Processes, 98(2), 97-120.

228. Courneya, K. S., Blanchard, C. M., & Laing, D. M. (2001). Exercise adherence

in breast cancer survivors training for a dragon boat race competition: a

preliminary investigation. Psycho-Oncology, 10(5), 444-452.

229. Courneya, K. S., & Friedenreich, C. M. (1999). Utility of the theory of planned

behavior for understanding exercise during breast cancer treatment. Psycho‐Oncology, 8(2), 112-122.

230. Vallance, J. K., Courneya, K. S., Taylor, L. M., Plotnikoff, R. C., & Mackey,

J. R. (2008). Development and Evaluation of a Theory-Based Physical Activity

Guidebook for Breast Cancer Survivors. Health Education & Behavior, 35(2),

174-189.

231. Courneya, K. S., Friedenreich, C. M., Arthur, K., & Bobick, T. M. (1999).

Understanding Exercise Motivation in Colorectal Cancer Patients: A

Prospective Study Using the Theory of Planned Behavior. Rehabilitation

Psychology, 44(1), 68-84.

232. Courneya, K. S., Keats, M. R., & Turner, A. R. (2000). Social cognitive

determinants of hospital-based exercise in cancer patients following high-dose

chemotherapy and bone marrow transplantation. International Journal of

Behavioral Medicine, 7(3), 189-203.

233. Courneya, K. S., & Friedenreich, C. M. (1997). Determinants of exercise

during colorectal cancer treatment: an application of the theory of planned

behavior. Oncology Nursing Forum, 24(10), 1715-1723.

234. Courneya, K. S., Friedenreich, C. M., Reid, R. D., Gelmon, K., Mackey, J. R.,

Ladha, A. B., & Segal, R. J. (2009). Predictors of follow-up exercise behavior

6 months after a randomized trial of exercise training during breast cancer

chemotherapy. Oncology Nursing Forum, 114(1), 179-187.

235. Courneya, K. S., Jones, L. W., Mackey, I. R., & Fairey, A. S. (2006). Exercise

beliefs of breast cancer survivors before and after participation in a randomized

controlled trial. International Journal of Behavioral Medicine, 13(3), 259-264.

236. Courneya, K. S., Vallance, J. K., Jones, L. W., & Reiman, T. (2005). Correlates

of exercise intentions in non-Hodgkin's lymphoma survivors: An application

of the theory of planned behavior. Journal of Sport & Exercise Psychology,

27(3), 335-349.

237. Vallance, J. K., Lavallee, C., Culos-Reed, N. S., & Trudeau, M. G. (2012).

Predictors of physical activity among rural and small town breast cancer

survivors: An application of the theory of planned behaviour. Psychology,

Health & Medicine, 17(6), 685-697.

238. Vallance, J. K. H., Courneya, K. S., Plotnikoff, R. C., & Mackey, J. R. (2008).

Analyzing Theoretical Mechanisms of Physical Activity Behavior Change in

Breast Cancer Survivors: Results from the Activity Promotion (ACTION)

Trial. Annals of Behavioral Medicine, 35(2), 150-158.

190 Bibliography

239. Andrykowski, M. A., Beacham, A. O., Schmidt, J. E., & Harper, F. K. (2006).

Application of the theory of planned behavior to understand intentions to

engage in physical and psychosocial health behaviors after cancer diagnosis.

Psycho‐Oncology, 15(9), 759-771.

240. Webb, T. L., Joseph, J., Yardley, L., & Michie, S. (2010). Using the Internet

to Promote Health Behavior Change: A Systematic Review and Meta-analysis

of the Impact of Theoretical Basis, Use of Behavior Change Techniques, and

Mode of Delivery on Efficacy. Journal of Medical Internet Research, 12(1),

NP-NP.

241. Buchan, D. S., Ollis, S., Thomas, N. E., & Baker, J. S. (2012). Physical activity

behaviour: An overview of current and emergent theoretical practices. Journal

of Obesity, 2012, 1-11.

242. Chatzisarantis, N. L. D., Frederick, C., Biddle, S. J. H., Hagger, M. S., & Smith,

B. (2007). Influences of volitional and forced intentions on physical activity

and effort within the theory of planned behaviour. Journal of Sports Sciences,

25(6), 699-709.

243. Motalebi, S. A., Iranagh, J. A., Abdollahi, A., & Lim, W. K. (2014). Applying

of theory of planned behavior to promote physical activity and exercise

behavior among older adults. Journal of Physical Education and Sport, 14(4),

562-568.

244. Blanchard, C. M., Courneya, K. S., Rodgers, W. M., & Murnaghan, D. M.

(2002). Determinants of exercise intention and behavior in survivors of breast

and prostate cancer: an application of the theory of planned behavior. Cancer

Nursing, 25(2), 88-95

245. Vallance, J. K., Courneya, K. S., Plotnikoff, R. C., Dinu, I., & MacKey, J. R.

(2008). Maintenance of physical activity in breast cancer survivors after a

randomized trial. Medicine and Science in Sports and Exercise, 40(1), 173-

180.

246. Vallance, J. K., Courneya, K. S., Plotnikoff, R. C., Yasui, Y., & Mackey, J. R.

(2007a). Randomized controlled trial of the effects of print materials and step

pedometers on physical activity and quality of life in breast cancer survivors.

Journal of Clinical Oncology, 25(17), 2352-2359.

247. Vallance, J. K., Friedenreich, C. M., Lavallee, C. M., Culos-Reed, N., Mackey,

J. R., Walley, B., & Courneya, K. S. (2016). Exploring the Feasibility of a

Broad-Reach Physical Activity Behavior Change Intervention for Women

Receiving Chemotherapy for Breast Cancer: A Randomized Trial. Cancer

Epidemiology, Biomarkers & Prevention, 25(2), 391-398.

248. Tudor-Locke, C., & Lutes, L. (2009). Why Do Pedometers Work?: A

Reflection upon the Factors Related to Successfully Increasing Physical

Activity. Sports Medicine, 39(12), 981-993.

249. Lyons, E. J., Lewis, Z. H., Mayrsohn, B. G., & Rowland, J. L. (2014). Behavior

Change Techniques Implemented in Electronic Lifestyle Activity Monitors: A

Systematic Content Analysis. Journal of Medical Internet Research, 16(8),

192-205.

250. Bravata, D. M., Smith-Spangler, C., Sundaram, V., Gienger, A. L., Lin, N.,

Lewis, R., & Sirard, J. R. (2007). Using Pedometers to Increase Physical

Activity and Improve Health: A Systematic Review. JAMA, 298(19), 2296-

2304.

Bibliography 191

251. Walker, R. K., Hickey, A. M., & Freedson, P. S. (2016). Advantages and

Limitations of Wearable Activity Trackers: Considerations for Patients and

Clinicians. Clinical Journal of Oncology Nursing, 20(6), 606-610.

252. Abrantes, A. M., Blevins, C. E., Battle, C. L., Read, J. P., Gordon, A. L., &

Stein, M. D. (2017). Developing a Fitbit-supported lifestyle physical activity

intervention for depressed alcohol dependent women. Journal of Substance

Abuse Treatment, 80, 88-97.

253. Broderick, J. M., Ryan, J., O'Donnell, D. M., & Hussey, J. (2014). A guide to

assessing physical activity using accelerometry in cancer patients. Supportive

Care in Cancer, 22(4), 1121-1130.

254. Izawa, K. P., Watanabe, S., Hiraki, K., Morio, Y., Kasahara, Y., Takeichi, N.,

& Omiya, K. (2012). Determination of the effectiveness of accelerometer use

in the promotion of physical activity in cardiac patients: a randomized

controlled trial. Archives of Physical Medicine and Rehabilitation, 93(11),

1896-1902.

255. Allet, L., Knols, R. H., Shirato, K., & de Bruin, E. D. (2010). Wearable systems

for monitoring mobility-related activities in chronic disease: a systematic

review. Sensors (Basel), 10(10), 9026-9052.

256. Schneider, P. L., Bassett Jr, D. R., Thompson, D. L., Pronk, N. P., & Bielak,

K. M. (2006). Effects of a 10,000 steps per day goal in overweight adults.

American Journal of Health Promotion, 21(2), 85-89.

257. Gokal, K., Wallis, D., Ahmed, S., Boiangiu, I., Kancherla, K., & Munir, F.

(2016). Effects of a self-managed home-based walking intervention on

psychosocial health outcomes for breast cancer patients receiving

chemotherapy: a randomised controlled trial. Supportive Care in Cancer,

24(3), 1139-1166.

258. Lewis, Z. H., Lyons, E. J., Jarvis, J. M., & Baillargeon, J. (2015). Using an

electronic activity monitor system as an intervention modality: A systematic

review. BMC Public Health, 15(1), 585-596.

259. NDP Research. (2014). Wearable tech device awareness surpasses 50 percent

among us consumers, according to NDP. Retrieved from:

https://www.npd.com/wps/portal/npd/us/news/press-releases/wearable-tech-

device-awarenesssurpasses-50-percent-among-us-consumers-according-to-

npd.

260. Salmon, J., & Ridgers, N.D., (2017). Is wearable technology an activity

motivator, or a fad that wears thin? Medical Journal Australia, 206(3), 119-

120.

261. Pitta, F., Troosters, T., Probst, V. S., Spruit, M. A., Decramer, M., & Gosselink,

R. (2006). Quantifying physical activity in daily life with questionnaires and

motion sensors in COPD. European Respiratory Journal, 27(5), 1040-1055.

262. Vaes, A. W., Cheung, A., Atakhorrami, M., Groenen, M. T. J., Amft, O.,

Franssen, F. M. E., & Spruit, M. A. (2013). Effect of 'activity monitor-based'

counseling on physical activity and health-related outcomes in patients with

chronic diseases: A systematic review and meta-analysis. Annals of Medicine,

45(5), 397-412.

263. The Business Insider (Allure Media). Just 3.3 million fitness trackers were sold

in the US in the past year. 2014 [cited 2015 March 2]; Available from:

http://www.businessinsider.com/33-million-fitnesstrackers-were-sold-in-the-

us-in-the-past-year-2014-5.

https://www.npd.com/wps/portal/npd/us/news/press-releases/wearable-tech-device-awarenesssurpasses-50-percent-among-us-consumers-according-to-npd



http://www.businessinsider.com/33-million-fitnesstrackers-were-sold-in-the-us-in-the-past-year-2014-5

http://www.businessinsider.com/33-million-fitnesstrackers-were-sold-in-the-us-in-the-past-year-2014-5

192 Bibliography

264. Wearable Inc ©. Best fitness trackers 2016: Fitbit, Garmin, Misfit and more.

2016; Retrieved from: http://www.wareable.com/fitness-trackers/the-best-

fitness-tracker.

265. Rosenberg, D., Kadokura, E. A., Bouldin, E. D., Miyawaki, C. E., Higano, C.

S., & Hartzler, A. L. (2016). Acceptability of Fitbit for physical activity

tracking within clinical care among men with prostate cancer. AMIA Annual

Symposium Proceedings, 2016, 1050-1059.

266. Rossi, A., Frechette, L., Miller, D., Miller, E., Friel, C., Van Arsdale, A., &

Nevadunsky, N. S. (2018). Acceptability and feasibility of a Fitbit physical

activity monitor for endometrial cancer survivors. Gynecologic Oncology,

149(3), 470-475.

267. Hartman, S. J., Nelson, S. H., Myers, E., Natarajan, L., Sears, D. D., Palmer,

B. W., & Patterson, R. E. (2017). Randomized controlled trial of increasing

physical activity on objectively measured and self-reported cognitive

functioning among breast cancer survivors: The memory & motion study.

Cancer, 124(1), 192-202.

268. Gell, N. M., Grover, K. W., Humble, M., Sexton, M., & Dittus, K. (2017).

Efficacy, feasibility, and acceptability of a novel technology-based

intervention to support physical activity in cancer survivors. Supportive Care

in Cancer, 25(4), 1291-1300.

269. Mendoza, J. A., Baker, K. S., Moreno, M. A., Whitlock, K., Abbey-Lambertz,

M., Waite, A., Chow, E. J. (2017). A Fitbit and Facebook mHealth intervention

for promoting physical activity among adolescent and young adult childhood

cancer survivors: A pilot study. Pediatric Blood & Cancer, 64(12), 23-31.

270. Cadmus-Bertram, L. A., Marcus, B. H., Patterson, R. E., Parker, B. A., &

Morey, B. L. (2015). Randomized Trial of a Fitbit-Based Physical Activity

Intervention for Women. American Journal of Preventive Medicine, 49(3),

414-418.

271. Wang, J. B., Cadmus-Bertram, L. A., Natarajan, L., White, M. M., Madanat,

H., Nichols, J. F., & Pierce, J. P. (2015). Wearable Sensor/Device (Fitbit One)

and SMS Text-Messaging Prompts to Increase Physical Activity in Overweight

and Obese Adults: A Randomized Controlled Trial. Telemedicine and e-

Health, 21(10), 782-792.

272. Thompson, W. G., Kuhle, C. L., Koepp, G. A., McCrady-Spitzer, S. K., &

Levine, J. A. (2014). "Go4Life" exercise counseling, accelerometer feedback,

and activity levels in older people. Archives Of Gerontology And Geriatrics,

58(3), 314-319.

273. Washington, W. D., Banna, K. M., & Gibson, A. L. (2014). Preliminary

efficacy of prize‐based contingency management to increase activity levels in

healthy adults. Journal of Applied Behavior Analysis, 47(2), 231-245.

274. Courneya, K. S., Segal, R. J., Gelmon, K., Reid, R. D., Mackey, J. R.,

Friedenreich, C. M., McKenzie, D. C. (2008). Predictors of supervised exercise

adherence during breast cancer chemotherapy. Medicine & Science in Sports

& Exercise, 40(6), 1180-1187.

275. Robertson, M. C., Tsai, E., Lyons, E. J., Srinivasan, S., Swartz, M. C., Baum,

M. L., & Basen-Engquist, K. M. (2017). Mobile Health Physical Activity

Intervention Preferences in Cancer Survivors: A Qualitative Study. JMIR

mHealth and uHealth, 5(1), 3-9.

276. Phillips, S. M., Conroy, D. E., Keadle, S. K., Pellegrini, C. A., Lloyd, G. R.,

Penedo, F. J., & Spring, B. (2017). Breast cancer survivors' preferences for

http://www.wareable.com/fitness-trackers/the-best-fitness-tracker

http://www.wareable.com/fitness-trackers/the-best-fitness-tracker

Bibliography 193

technology-supported exercise interventions. Supportive Care in Cancer,

25(10), 3243-3252.

277. Middleton, K. R., Anton, S. D., & Perri, M. G. (2013). Long-Term Adherence

to Health Behavior Change. American Journal of Lifestyle Medicine, 7(6), 395-

404.

278. Ashe, M. C., Winters, M., Hoppmann, C. A., Dawes, M. G., Gardiner, P. A.,

Giangregorio, L. M., & McKay, H. A. (2015). “Not just another walking

program”: Everyday Activity Supports You (EASY) model—a randomized

pilot study for a parallel randomized controlled trial. Pilot and Feasibility

Studies, 1(4), 1-12.

279. Vallance, J. K. H., Courneya, K. S., Plotnikoff, R. C., Yasui, Y., & Mackey, J.

R. (2007b). Randomized Controlled Trial of the Effects of Print Materials and

Step Pedometers on Physical Activity and Quality of Life in Breast Cancer

Survivors. Journal of Clinical Oncology, 25(17), 2352-2359.

280. Nigg, C. R., Borrelli, B., Maddock, J., & Dishman, R. K. (2008). A Theory of

Physical Activity Maintenance. Applied Psychology an International Review,

57(4), 544-560.

281. Clayton, C., Feehan, L., Goldsmith, C. H., Miller, W. C., Grewal, N., Ye, J., &

Li, L. C. (2015). Feasibility and preliminary efficacy of a physical activity

counseling intervention using Fitbit in people with knee osteoarthritis: the

TRACK-OA study protocol. Pilot and Feasibility Studies, 1(30), 1-12.

282. Ritvo, P., Obadia, M., Santa Mina, D., Alibhai, S., Sabiston, C., Oh, P., &

Jones, J. M. (2017). Smartphone-Enabled Health Coaching Intervention

(iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast

Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled

Trial. JMIR Research Protocols, 6(8), e165.

283. Bennett, J. A., Lyons, K. S., Winters-Stone, K., Nail, L. M., & Scherer, J.

(2007). Motivational Interviewing to Increase Physical Activity in Long-Term

Cancer Survivors: A Randomized Controlled Trial. Nursing Research, 56(1),

18-27.

284. Vallance, J. K., Murray, T. C., Johnson, S. T., & Elavsky, S. (2011).

Understanding Physical Activity Intentions and Behavior in Postmenopausal

Women: An Application of the Theory of Planned Behavior. International

Journal of Behavioral Medicine, 18(2), 139-149.

285. Fishbein, M., von Haeften, I., & Appleyard, J. (2001). The role of theory in

developing effective interventions: Implications from Project SAFER.

Psychology, Health & Medicine, 6(2), 223-238.

286. Fjeldsoe, B.S., Miller Y.D, Graves N., Barnett A.G., Marshall A.L. (2015).

Randomized Controlled Trial of an Improved Version of MobileMums, an

Intervention for Increasing Physical Activity in Women with Young Children.

Annals of Behavioral Medicine, 49(4), 487-99.

287. Short, C. E., James, E. L., Rebar, A. L., Duncan, M. J., Courneya, K. S.,

Plotnikoff, R. C., & Vandelanotte, C. (2017). Designing more engaging

computer-tailored physical activity behaviour change interventions for breast

cancer survivors: lessons from the iMove More for Life study. Supportive Care

in Cancer, 25(11), 3569-3585.

288. Abbott, L., & Hooke, M. C. (2017). Energy Through Motion: An Activity

Intervention for Cancer-Related Fatigue in an Ambulatory Infusion Center.

Clinical Journal of Oncology Nursing, 21(5), 618-626.

194 Bibliography

289. Nguyen, N. H., Hadgraft, N. T., Moore, M. M., Rosenberg, D. E., Lynch, C.,

Reeves, M. M., & Lynch, B. M. (2017). A qualitative evaluation of breast

cancer survivors' acceptance of and preferences for consumer wearable

technology activity trackers. Supportive Care in Cancer, 25(11):3375-3384.

290. Sherwood, N. E., Martinson, B. C., Crain, A. L., Hayes, M. G., Pronk, N. P.,

& O'Connor, P. J. (2008). A new approach to physical activity maintenance:

Rationale, design, and baseline data from the Keep Active Minnesota trial.

BMC Geriatrics, 8(1), 17-23.

291. Rogers, L. Q., Hopkins-Price, P., Vicari, S., Markwell, S., Pamenter, R.,

Courneya, K. S., & Verhulst, S. (2009). Physical Activity and Health Outcomes

Three Months After Completing a Physical Activity Behavior Change

Intervention: Persistent and Delayed Effects. Cancer Epidemiology

Biomarkers & Prevention, 18(5), 1410-1421.

292. Murphy, S. L., Lyden, A. K., Clary, M., Geisser, M. E., Yung, R. L., Clauw,

D. J., & Williams, D. A. (2011). Activity pacing for osteoarthritis symptom

management: Study design and methodology of a randomized trial testing a

tailored clinical approach using accelerometers for veterans and non-veterans.

BMC Musculoskeletal Disorders, 12(1), 177-187.

293. Cain, Kelli L., & Geremia Carrie M. (2012). Accelerometer Data Collection

and Scoring Manual For Adult & Senior Studies. San Diego State University,

San Diego, CA. Retrieved from: http://sallis.ucsd.edu/measures.html

294. Reeves, M. M., Terranova, C. O., Erickson, J. M., Job, J. R., Brookes, D. S.,

McCarthy, N., Eakin, E. G. (2016). Living well after breast cancer randomized

controlled trial protocol: evaluating a telephone-delivered weight loss

intervention versus usual care in women following treatment for breast cancer.

BMC Cancer, 16(1), 830-843.

295. Garber, C. E., Blissmer, B., Deschenes, M. R., Franklin, B. A., Lamonte, M.

J., Lee, I. M., & Swain, D. P. (2011). American College of Sports Medicine

position stand. Quantity and quality of exercise for developing and maintaining

cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently

healthy adults: guidance for prescribing exercise. Medicine & Science in Sports

& Exercise, 43(7), 1334-1359.

296. Hartman, S. J., Dunsiger, S. I., Bock, B. C., Larsen, B. A., Linke, S., Pekmezi,

D., & Marcus, B. H. (2017). Physical activity maintenance among Spanish-

speaking Latinas in a randomized controlled trial of an Internet-based

intervention. Journal of Behavioral Medicine, 40(3), 392-402.

297. Hartman, S. J., Nelson, S. H., Cadmus-Bertram, L. A., Patterson, R. E., Parker,

B. A., & Pierce, J. P. (2016). Technology- and Phone-Based Weight Loss

Intervention: Pilot RCT in Women at Elevated Breast Cancer Risk. American

Journal of Preventive Medicine, 51(5), 714-721.

298. Eton, D. T., Cella, D., Yost, K. J., Yount, S. E., Peterman, A. H., Neuberg, D.

S., & Wood, W. C. (2004). A combination of distribution- and anchor-based

approaches determined minimally important differences (MIDs) for four

endpoints in a breast cancer scale. Journal of Clinical Epidemiology, 57(9),

898-910.

299. Cella, D., Hahn, E. A., & Dineen, K. (2002). Meaningful change in cancer-

specific quality of life scores: differences between improvement and

worsening. Quality of Life Research, 11(3), 207-221.

300. Agboola, S., Palacholla, R. S., Centi, A., Kvedar, J., & Jethwani, K. (2016). A

Multimodal mHealth Intervention (FeatForward) to Improve Physical Activity

Bibliography 195

Behavior in Patients with High Cardiometabolic Risk Factors: Rationale and

Protocol for a Randomized Controlled Trial. JMIR Research Protocols, 5(2),

84-89.

301. Hayes, S. C., Reul-Hirche, H., & Turner, J. (2009). Exercise and secondary

lymphedema: safety, potential benefits, and research issues. Medicine and

Science in Sports and Exercise, 41(3), 483-489.

302. Lahart, I. M., Metsios, G. S., Nevill, A. M., Kitas, G. D., & Carmichael, A. R.

(2016). Randomised controlled trial of a home-based physical activity

intervention in breast cancer survivors. BMC Cancer, 16, 1-14.

303. Duncan, M. J., Vandelanotte, C., Trost, S. G., Rebar, A. L., Rogers, N., Burton,

N. W., & Brown, W. J. (2016). Balanced: a randomised trial examining the

efficacy of two self-monitoring methods for an app-based multi-behaviour

intervention to improve physical activity, sitting and sleep in adults. BMC

Public Health, 16, 670-681.

304. Poirier, J., Bennett, W. L., Jerome, G. J., Shah, N. G., Lazo, M., Yeh, H. C., &

Cobb, N. K. (2016). Effectiveness of an Activity Tracker- and Internet-Based

Adaptive Walking Program for Adults: A Randomized Controlled Trial.

Journal of Medical Internet Research, 18(2), 34-41.

305. Wang, J. B., Cataldo, J. K., Ayala, G. X., Natarajan, L., Cadmus-Bertram, L.

A., White, M. M., & Pierce, J. P. (2016). Mobile and Wearable Device Features

that Matter in Promoting Physical Activity. Journal of Mobile Technology in

Medicine, 5(2), 2-11.

306. Bernardo, L. M., Abt, K. L., Ren, D., & Bender, C. (2010). Self-reported

exercise during breast cancer treatment: results of a national survey. Cancer

Nursing, 33(4), 304-309.

307. Schmidt, M. E., Wiskemann, J., Ulrich, C. M., Schneeweiss, A., & Steindorf,

K. (2017). Self-reported physical activity behavior of breast cancer survivors

during and after adjuvant therapy: 12 months follow-up of two randomized

exercise intervention trials. Acta Oncologica, 56(4), 618-627.

308. Neil-Sztramko, S. E., Winters-Stone, K. M., Bland, K. A., & Campbell, K. L.

(2017). Updated systematic review of exercise studies in breast cancer

survivors: attention to the principles of exercise training. British Journal of

Sports Medicine 0, 1-11.

309. Mina, D. S., Petrella, A., Currie, K. L., Bietola, K., Alibhai, S. M. H.,

Trachtenberg, J., & Matthew, A. G. (2015). Enablers and barriers in delivery

of a cancer exercise program: the Canadian experience. Current Oncology,

22(6), 374-384.

310. Courneya, K. S., Segal, R. J., Vallerand, J. R., Forbes, C. C., Crawford, J. J.,

Dolan, L. B., McKenzie, D. C. (2016). Motivation for Different Types and

Doses of Exercise During Breast Cancer Chemotherapy: a Randomized

Controlled Trial. Annals of Behavioral Medicine, 50(4), 554-563.

311. Giles, M., Connor, S., McClenahan, C., Mallett, J., Stewart-Knox, B., &

Wright, M. (2007). Measuring young people's attitudes to breastfeeding using

the Theory of Planned Behaviour. Journal of Public Health, 29(1), 17-26.

312. Oluka, O. C., Sun, Y., Komlan, K., Sun, L., & Zhang, L. (2017). Barriers to

Provision of Lifestyle Counseling to Cancer Survivors: A Theory of Planned

Behavior Study. SAGE Open, 7(2), 1-9.

313. Ajzen, I., & Fishbein, M. (1980). Understanding attitudes and predicting social

behavior. London; Englewood Cliffs, Prentice-Hall.

196 Bibliography

314. Conn, V. S., Tripp‐Reimer, T., & Maas, M. L. (2003). Older Women and

Exercise: Theory of Planned Behavior Beliefs. Public Health Nursing, 20(2),

153-163.

315. Glanz, K., Rimer, B. K., & Viswanath, K. (2008). Health behavior and health

education: theory, research, and practice (4th ed.). San Francisco: Jossey-Bass.

316. Lin, S. F., Lee, J. W., Modeste, N., & Johnson, E. G. (2012). Attitudes and

Beliefs Predicting Taiwanese Older Adults’ Intentions to Attend Strength and

Balance Training Programs. Journal of Applied Gerontology, 31(2), 260-281.

317. Plotnikoff, R. C., Lippke, S., Courneya, K., Birkett, N., & Sigal, R. (2010).

Physical activity and diabetes: An application of the theory of planned

behaviour to explain physical activity for Type 1 and Type 2 diabetes in an

adult population sample. Psychology & Health, 25(1), 7-23.

318. Cooke, R., & French, D. P. (2008). How well do the theory of reasoned action

and theory of planned behaviour predict intentions and attendance at screening

programmes? A meta-analysis. Psychology & Health, 23(7), 745-765.

319.. Nigg, C. R., Lippke, S., & Maddock, J. E. (2009). Factorial invariance of the

theory of planned behavior applied to physical activity across gender, age, and

ethnic groups. Psychology of Sport & Exercise, 10(2), 219-225.

320. Kosma, M. (2014). An Expanded Framework to Determine Physical Activity

and Falls Risks Among Diverse Older Adults. Research on Aging, 36(1), 95-

114.

321. Antikainen, I., Ellis, R., Kosma, M., Allen, P. D., Cherry, K. E., Monroe, P.

A., & Wood, R. H. (2010). Examining Change in Theory-based Physical

Activity Beliefs of Culturally Diverse Older Adults. Journal of Applied

Gerontology, 29(4), 507-517.

322. Courneya, K.S. (1995), Understanding Readiness for Regular Physical

Activity in Older Individuals: An Application of the Theory of Planned

Behavior. Health Psychology, 14(1): p. 80-87.

323. Schwarzer, R. (2008). Modeling Health Behavior Change: How to Predict and

Modify the Adoption and Maintenance of Health Behaviors. Applied

Psychology An International Review, 57(1), 1-29.

234. Mazzoni, A.S., Nordin, K., Berntsen, S., Demmelmaier, I., & Igelström, H.

(2017). Comparison between logbook-reported and objectively-assessed

physical activity and sedentary time in breast cancer patients: an agreement

study. BMC Sports Science, Medicine and Rehabilitation, 9(8):2-9.

197

Appendices

4.4 APPENDIX A: SYSTEMATIC REVIEW AND META-ANALYSIS

MANUSCRIPT

239

4.5 APPENDIX B. RESULTS TABLES FROM THE SECONDARY DATA

ANALYSES OF SECTION 2.3.

Table 1. Baseline characteristics of participants grouped by 1 to 7 sessions and 8 to

14 sessions with an AEP.

1 to 7 sessions

n=43

Mean (SD) or n (%)

8 to 14 sessions

n=159

Mean (SD) or n (%)

Age (years) 52.6 (8.1) 51.5 (8.9)

Body mass index (kg/m2)

Underweight (<18.5)

Normal (18.5–24.9)

Overweight (25–29.9)

Obese (>30)

2.4%

30.2%

37.2%

30.2%

0.6%

48.4%

30.2%

20.8%

Previous smoker (yes) 9.3% 6.3%

Treating hospital

Private

Public

58.1%

41.9%

56.6%

43.4%

Number of nodes dissected,

median (minimum, maximum)

5 (1, 26) 7 (1, 30)

Cancer stage

0

I

II/III

5.1%

25.6%

66.7%/2.6%

1.9%)

36.1%)

60.0%/ 1.9%

Tumor grading—overall

histological grade

Grade 1

Grade 2

Grade 3

Unknown or missing

10.3%

51.3%

28.2%

10.3%

15.2%

39.2%

39.9%

5.7%

Chemotherapy1 (Yes)

Radiotherapy1 (Yes)

Hormone therapy1 (Yes)

80.0%

55.0%

53.7%

61.0%

45.6%

65.4%

Intervention group

Face-to-face

Telephone

37.2%

62.8%

30.2%

69.8%

Physically active at baseline (yes) 72.1% 69.2% 1 Currently and/or previously received this treatment. 2 Physically active defined as meeting the Australian National Physical activity

guidelines (150 minutes per week).

AEP: Accredited exercise physiologist.

241

Table 2. Quality of life, fatigue and aerobic fitness at baseline, 6 months post-surgery

and changes scores presents as 1−7 AEP sessions and 8–14 AEP session groupings:

adjusted analyses.

Baseline

Mean (95% CI)

6 months post-surgery

Mean (95% CI)

Δ from baseline to 6

months post-surgery

Mean Δ (95% CI)

Quality of life a

1−7 AEP Sessions

(n=43)

113.60 (107.78, 119.42) 116.59 (108.94, 124.86) 3.29 (–2.93, 9.53)

8–14 AEP Sessions

(n=159)

116.90 (113.82, 119.97) 122.32 (119.22, 125.42) 5.42 (3.00, 7.85) 1

Fatigue b

1−7 AEP Sessions

(n=43)

34.71 (31.34, 38.08) 35.39 (30.87, 39.91) 0.67 (-3.28, 4.63)

8–14 AEP Sessions

(n=159)

35.59 (33.83, 37.34) 37.80 (36.14, 39.46) 2.21 (0.48, 3.94) 1

Aerobic fitness c

1−7 AEP Sessions

(n=43)

95.73 (89.70, 101.77) 96.48 (89.73, 103.22) 0.74 (–5.79, 7.28)

8–14 AEP Sessions

(n=159)

94.67 (91.50, 97.84) 92.36 (89.38, 95.35) –2.30 (–5.01, 0.40)

Results adjusted for age, BMI, smoking status, baseline physical activity, working status, income,

intervention group (face to face or telephone), receipt of chemotherapy, radio therapy and hormone

therapy, disease stage, surgery, and study arm (urban or rural) a Quality of life as measured by the FACT-B +4 scale. Higher scores indicate better well-being

(scale range: 0–160); change overtime or difference between groups [8 units is clinically

important] b Fatigue as measured by the FACIT-F Questionnaire. Lower scores indicate higher levels of

fatigue (scale: 0–52); change overtime or difference between groups >5 units is clinically

important c Aerobic fitness as assessed by heart rate on completion of modified 3 min step test. Lower heart

rate indicates better fitness; change overtime or difference between groups >1/2 standard deviation

(8 beats/min) is clinically important

NOTE: No significant between group differences at 6 months post-surgery for each outcome 1 Statistically significant difference from baseline at the 0.05 level

243

4.6 APPENDIX C: COPY OF THE PUBLISHED COMMENTARY

ARTICLE FROM THE SECONDARY ANALYSES OF SECTION 2.3.

Title: Can five sessions per year with an AEP make a difference to the lives of those

with a chronic disease?

Authors: Mr. Benjamin Singh, Dr. Rosa Spence, Professor Elizabeth Eakin, Professor

Sandi Hayes

The intent of a Chronic Disease Management Plan (CDMP) is to enable General

Practitioners to plan and coordinate the health care of those with chronic or terminal

medical conditions, or complex care needs, requiring multidisciplinary care [1]. The

plan was introduced in 1999, known then as an Enhanced Primary Care Plan. Currently

under this plan, patients can receive up to five visits with specific allied health

professionals including AEPs. Yet, the ability to effectively manage chronic or

complex diseases or conditions under the current CDMP structure is unclear. Below,

we use our experiences in the breast cancer setting to explore this issue further.

There is compelling evidence that supports exercise as an important, safe and feasible

adjuvant therapy for breast cancer [2, 3]. Benefits accrued through exercise therapy

during and following treatment for breast cancer include functional and psychosocial

benefits, reduced frequency and severity of treatment-related side effects and,

potentially, survival benefits [4, 5]. To date, over 100 exercise intervention trials

involving aerobic- and resistance-based exercise performed during and following

treatment have explored the role of exercise post-breast cancer. The majority of

interventions evaluated have been at least 12-weeks in duration, with at least one

supervised exercise session per week. This is in contrast to the current funding model,

where a maximum of five funded visits over a one-year period are provided under the

CDMP.

The Exercise for Health trial was Australia’s first exercise effectiveness trial in the

breast cancer setting. This means that the intervention evaluated was delivered under

real-world conditions; that is, an AEP prescribed exercise on an individualised-basis

(taking into consideration needs, goals, and exercise barriers and motivators) to

women recently diagnosed with breast cancer [6, 7]. Participants randomised to the

exercise intervention group were expected to meet regularly with their AEP from

approximately 6 weeks after surgery for breast cancer and received up to 14 sessions

by 6 months post-surgery. Frequency of sessions with their allocated AEP was weekly

during the initial weeks of the intervention (which coincided with their active adjuvant

treatment) and then tapered to monthly sessions around 4-months post-diagnosis. The

weekly exercise dose targets were 180 minutes of moderate-intensity, mixed-type

exercise, although the more pragmatic goal was to develop independent exercisers

capable of appropriately adapting their exercise to accommodate new or regular

barriers (that may or may not have been related to their breast cancer).

Participating in the Exercise for Health intervention was shown to be effective for

improving breast cancer survivorship outcomes including fatigue, aerobic fitness, and

overall quality of life [6, 7], and was shown to be cost effective [8]. Very recent

findings also showed that those in the exercise group more than halved their risk of

dying up to 8-years post-breast cancer, compared with those in the control group [9].

While adherence to the intervention protocol was high (that is, participants completed

over 80% of the 14 scheduled AEP-sessions by 6 months post-diagnosis), due to the

pragmatic nature of the trial, some women received as few as 4 sessions with their

AEP during this same period. As such, these data provided an opportunity to explore

the relationship between change in patient outcomes (including fatigue, fitness and

quality of life) and number of sessions with an AEP, with a non-linear relationship

identified. Subsequent exploratory analyses showed that receipt of 8+ sessions with an

AEP was associated with greater improvements in fitness and quality of life (p<0.05)

and less fatigue (p<0.05) compared with receipt of <8 sessions. Exploratory survival

analysis also suggested that greater survival benefits was accrued for those who

received at least 10 sessions with their AEP compared with those who received <10

sessions.

So, what does all this mean? First, it is important to remember that these findings are

derived from exploratory analyses with non-randomised groupings. This means that

these results reflect associations and do not infer causality. Nonetheless, findings are

thought-provoking and can be used to ensure AEPs are primed to make the best of our

current funding situation. AEPs have expertise in prescribing exercise for complex

cases and the need to integrate behaviour change strategies into sessions with patients

from the outset is paramount to making a difference in the lives of those with chronic

disease for the longer term. Specifically, understanding a patient’s exercise self-

efficacy and providing them with the skills and capacity to identify and overcome

245

barriers will be just as important as the exercise prescription given. Also, being flexible

in the way in which AEP services can be delivered is important. Traditionally, AEP

services have required a one-on-one and face-to-face approach. Yet, evidence supports

the efficacy of telephone-delivery [10] and/or group-based delivery [11] in improving

health in a range of chronic disease settings [12, 13]. Being flexible in the delivery of

AEP services now and into the future will be necessary to accommodate current patient

barriers. For example, limited access to AEP services particularly for those living in

more rural, regional areas, or for subgroups such as younger women juggling full-time

employment and childcare with limited time.

Making use of other rebatable schemes driven by organisations such as the Department

of Veterans Affairs and Private Health Funds to supplement the Medicare CDMP when

appropriate and necessary is a way to extend continuity of care. Future research, in

particular cost-effectiveness research, will help guide our health system in making

more evidence-based decisions around models of care. Until then, AEPs need to work

wisely within the constraints of the available funding. AEPs can have a profound and

favourable impact in supporting exercise uptake in the short- and longer-term, and in

doing so, will be able to improve the lives of their patients, as well as contribute to

better public health.

References (Please note this reference list is only for this published commentary article

and not the entire thesis).

1. Australian Government Department of Health, Chronic disease management -

patient information. 2015.

2. Hayes, S.C., et al., Australian Association for Exercise and Sport Science position

stand: Optimising cancer outcomes through exercise. Journal of Science and Medicine

in Sport, 2009. 12(4): p. 428-434.

3. Schmitz, K.H., et al., American College of Sports Medicine roundtable on exercise

guidelines for cancer survivors. Medicine and science in sports and exercise, 2010.

42(7): p. 1409-1426.

4. Cormie, P., et al., The Impact of Exercise on Cancer Mortality, Recurrence, and

Treatment-Related Adverse Effects. Epidemiol Rev, 2017: p. 1-22.

5. Speck, R.M., et al., An update of controlled physical activity trials in cancer

survivors: a systematic review and meta-analysis. Journal of Cancer Survivorship,

2010. 4(2): p. 87-100.

6. Hayes, S.C., et al., Exercise for health: a randomized, controlled trial evaluating the

impact of a pragmatic, translational exercise intervention on the quality of life,

function and treatment-related side effects following breast cancer. Breast Cancer

Research and Treatment, 2013. 137(1): p. 175-186.

7. Eakin, E.G., et al., Telephone Interventions for Physical Activity and Dietary

Behavior Change. A Systematic Review. American Journal of Preventive Medicine,

2007. 32(5): p. 419-434.

8. Gordon, L.G., et al., Cost-effectiveness of a pragmatic exercise intervention for

women with breast cancer: results from a randomized controlled trial.

Psychooncology, 2016.

9. Hayes, S.C., et al., Can exercise influence survival following breast cancer: Results

from a randomised, controlled trial. Journal of Clinical Oncology, 2017. 35(15_suppl):

p. 10067-10067.

10. Goode, A.D., et al., Telephone, print, and Web-based interventions for physical

activity, diet, and weight control among cancer survivors: a systematic review. Journal

of Cancer Survivorship, 2015. 9(4): p. 660-682.

11. Mutrie, N., et al., Benefits of supervised group exercise programme for women

being treated for early stage breast cancer: pragmatic randomised controlled trial.

BMJ, 2007. 334(7592): p. 517.

12. Pedersen, B.K. and M.A. Febbraio, Muscle as an Endocrine Organ: Focus on

Muscle-Derived Interleukin-6. Physiological Reviews, 2008. 88(4): p. 1379-1406.

13. Pedersen, B.K. and L. Hoffman-Goetz, Exercise and the immune system:

regulation, integration, and adaptation. Physiological Reviews, 2000. 80(3): p. 1055-

1081.

247

4.7 APPENDIX D: TELEPHONE SCREENING QUESTIONNAIRE

255

4.8 APPENDIX E: CASE MANAGEMENT FOLDER (USED BY THE EXERCISE PHYSIOLOGIST)

4.9 APPENDIX F: PARTICIPANT EXERCISE LOGBOOK

273

4.10 APPENDIX G: DATA COLLECTION SHEET

275

4.11 APPENDIX H: SUMMARY OF STATISTICAL TESTS USED FOR EACH OUTCOME

Outcome Test or instrument used Continuous or categorical outcome

Descriptive statistics or type of analysis

Clinically meaningful change [reference]

Safety None Categorical Occurrence of adverse events

Feasibility None Categorical Met predefined criteria of 75%

Compliance None Continuous and

categorical

Mean (SD) or median

(minimum, maximum)

Objectively-

measured:

3. Aerobic fitness 6-minute walk test (total distance walked, metres)

Continuous t-test or Wilcoxon sign-rank tests

25 metres [4, 164]

4. Upper-body

strength

YMCA bench press test (total no. of

repetitions)

Continuous t-test or Wilcoxon sign-rank

tests

10% [4]

5. Lower-body

strength

30 second sit-to-stand test (total no. of

repetitions)


tests

2 repetitions [165]

6. Balance Single leg stance test (total duration,

seconds)


tests

8 seconds [4]

7. Body weight Scales (weight in kilograms) Continuous t-test or Wilcoxon sign-rank tests

5% [165]

8. Body mass

index

Height and weight (kg/m2) Continuous t-test or Wilcoxon sign-rank

tests

1 kg/m2 [167]

9. Body

composition

Bioimpedance spectroscopy (% body

fat)


tests

2% [166]

Participant-reported: 10. Quality of life FACT-G

Physical wellbeing

Emotional wellbeing Social wellbeing

Functional wellbeing

PROMIS Global Health Scale Short-form

Physical health

Mental health

PROMIS-43 Profile

Physical function

Anxiety Depression

Fatigue

Sleep Satisfaction with social roles

Pain interference

Continuous

Continuous

Continuous

t-test or Wilcoxon sign-rank

tests t-test or Wilcoxon sign-

rank tests

t-test or Wilcoxon sign-rank tests

>8 units [153]

>2 units [153]

4 units [4]

4 units [4]

11. Upper-extremity

function

PROMIS Upper-extremity Scale Continuous t-test or Wilcoxon sign-rank tests

3.5 units [4]

12. Exercise self-efficacy

Barrier self-efficacy scale Continuous t-test or Wilcoxon sign-rank tests

7 units [145]

13. Physical

activity

The Active Australia Survey Continuous and

categorical

t-test and chi-square tests 60 minutes per week of walking 30 minute per week

for MVPA [76]

FACT-G: Functional Assessment of Cancer Therapy - General


277

4.12 APPENDIX I: LOG OF ALL ADVERSE EVENTS

ID Adverse event (AE) Description AE

Grade1

Relationship

of event to

exercise int2.

Relationship

of event to

non-study

related

factors3

Is this

event a

Serious

AE?4

Did

the AE

result

in

hosp.?5

Stage

of int.6

Impact

on int.7

Recommendation8 Recommendation notes Present

status

of AE9

Present Status notes Length

(days)10

2 Pain and swelling in hands 2 4 3 No No 5 1 2 No change exercise prescription as it is

not aggravating it

1 Pain; ongoing side effect of treatment 47

3 Severe upper-body DOMS following

baseline data collection exercise testing

(YMCA chest press).

3 3 2 No No 0 1 1 Discussed exercise safety, RPE and

gradual progression.

3 AEP to monitor to make sure she is

exercising within her limits

4

3 Bilateral knee pain associated with

existing osteoarthritis; Pain with walking

(however not worse than usual)

1 3 3 No No 1 1 3 Discussed alternative modes of exercise

(i.e., swimming and cycling) as instead of

walking due to pain during walking.

3 Knee pain recovered that session after

rest; focus on building strength around

knees for support; participant have

incorporated swimming and cycling

into her program

0

6 Disease Progression 3 4 3 Yes Yes 3 3 5 Ceased exercise 4 NA -

7 Mild DOMS 1 3 4 No No 2 1 1 Mild - Pt not concerned 3 NA 0

7 Mild Hip tightness 1 3 3 No No 9 1 1 Mild - Pt not concerned 3 Patient self-manages and has added in

yoga and stretching into her program

0

9 Virus 2 4 3 No No 8 2 3 No exercise for 3 days 3 Return to exercise 3

9 Sore feet 1 3 3 No No 4 1 3 Reduced walking (duration and

frequency)

3 Reduced exercise frequency 32

11 Abdominal pain during hip extension 1 3 4 No No 1 1 3 Avoided hip ext. exercise 3 Avoided hip extension 0

11 Mild sudden pain in right elbow during

treadmill walking

1 4 4 No No 10 1 1 Nil (sudden and acute, <5 5 seconds) 3 Fully resolved 0

12 Illness (virus), feeling unwell 2 4 3 No No 1 2 3 Avoided exercise 3 Rested from exercise but back full

exercise.

5

15 Back injury during work (i.e.,

occupation)

2 4 3 No No 4 1 1 Pain resolved by appointment 3 Added Pilates-based stability exercises

to strengthen back for work duties

2

23 Mild DOMS 1 3 4 No No 1 1 1 Participant not concerned - monitor 3 NA 2

23 Participant feeling unwell, high

temperature (AEP clinical decision

making = unsafe to exercise)

2 4 3 No No 5 1 3 No exercise today. See GP/Hospital if

continue to be unwell

1 Ongoing until end of intervention -

23 Hospitalised with infection; unable to

complete 12 weeks; 2 weeks in hospital;

2 weeks at home on antibiotic IV;

operation to surgically remove infection.

3 4 3 Yes Yes 6 3 5 1 Ongoing until end of intervention 53

24 Mild DOMS (24hrs post-exercise) 1 3 4 No No 2 1 1 Monitor 1 NA 1

24 Increase in lymphoedema (forearm and

hand swelling); L-dex score still <10;

had to get new sleeve; PT concerned

about summer and wants to see her

monthly

1 4 3 No No 9 1 3 Monitor 1 NA 1

24 Adverse reaction to CT; prescribed

Phenergan which made her groggy and

2 4 3 No No 8 2 1 AEP saw participant after the event 3 NA 3

emotional; RPE for ex increased between

5/10-8/10

24 Progressive worsening of asthma;

Oncologist has suggested a visit to

respiratory specialist.

2 4 3 No No 5 2 1 Ongoing Chronic Condition 1 NA 0

26 Cold and flu like symptoms 1 4 3 No No 9 1 3 Continue walking but avoid resistance

exercise

3 Recovered in 7 days 7

43 Mild DOMS (lower-body only) 1 3 4 No No 1 1 1 DOMS resolved. No alteration to

program. Provided education of DOMS

3 NA 14

43 Mild DOMS 1 3 4 No No 5 1 1 DOMS resolved. No alteration to

program.

3 NA 1

43 Sore back muscles 2 3 1 No No 11 1 2 To see GP if back pain continues 2 Discussed correct lifting technique 3

44 Right Hip pain (following prolonged

sitting at work with bad posture)

2 4 1 No No 3 1 3 Advised to break up prolonged sitting

(e.g., with short walks and stretching)

1 Participant experienced recurring pain

but resolved with no sequelae (was

temporary and not experienced again)

0

44 Pain during upper-body exercise (lat-

pulldown exercise only)

1 2 1 No No 8 1 3 Perform exercise in pain free range of

motion

2 Participant discussed with GP; due to

radiation scarring

1

44 Increased arm swelling 1 4 3 No No 6 1 1 AEP and participant believe it may be

attributed to biopsy and mole removal on

this side of the body; not exercise-related

3 Discussed with participant that exercise

shouldn't cause LE and can benefit LE

(participant avoided exercise at this

time)

4

45 Increased shoulder pain in left in tricep

during arm extension (during first

repetition)

1 3 1 No No 1 2 3 Substituted ex to triceps press down;

continued remainder of session as per

normal

1 NA 1

45 Left shoulder pain 2 3 4 No No 2 2 4 Participant said she will see GP about

shoulder; participant has had cortisone

injections previously but they have been

ineffective; prescribed rotator cuff Thera-

band exercise.

1 Pain resolved 7

47 Mild DOMS post-exercise 1 3 4 No No 1 1 1 Resolved 3 Resolved 1

47 Foot pain in arches following walking 1 3 2 No No 6 1 3 Prescribed calf raise exercise and calf

stretch.

3 Participant using orthotics (prescribed

previously by podiatrist)

1

47 Flu 2 4 3 No No 7 2 1 Participant uncontactable at the time;

education to rest while unwell and gradual

progression back to exercise.

3 Resolved 13

49 Mild DOMS post-exercise (following 1st

exercise session only)

1 3 4 No No 1 1 1 Nil 3 NA 4

49 Mild lower back pain (during bent over

row exercise)

1 2 3 No No 1 1 3 Substituted bent-over row exercise to

seated machine row.

3 Participant said Pilates helped 13

49 Lower back pain following moving

furniture at home and AEP feels it might

also be caused by getting on and off low

floor Pilates machine; mild pain felt

during exercise.

2 2 3 No No 5 1 4 Changed row to upright row and told

participant to avoid using machine for a

couple of weeks. Participant concerned

about LBP so consulted GP (fear of

recurrence). Prescribed cat stretch and

knee rock

3 Avoided Pilates machine; visited GP

and test results show no cancer

recurrence (participant feeling better

emotionally)

30

49 Neck pain following moving furniture at

home

1 4 3 No No 9 1 1 Nil 3 Participant went for massage 9

53 Mild foot and leg pain following walking 2 3 3 No No 3 1 2 Participant self-manages walking

duration. Advised to GP or podiatrist (for

more supportive footwear).

1 Participant visited podiatrist -

53 Swelling legs and feet 2 3 3 No No 5 1 2 Participant has visited GP; heart and

kidneys fine; on diuretic; cause unknown.

4 NA 0

279

53 Increased fatigue post-exercise

(completed new exercise class)

2 3 3 No No 5 2 2 No change exercise prescription;

discussed FITT and safe exercise intensity

when exercising at park.

3 NA 4

53 Pericardial pain; participant was

concerned went to hospital, ECHO

results fine; virus.

2 4 3 Yes Yes 3 2 4 Monitor Ex. participant rested in 2nd

week due to being unwell

3 Visited GP; no evidence pericarditis

from cardiac tests; resolved

21

53 Feet soreness following walking 2 3 3 No No 9 1 2 Participant referred to podiatrist; requires

review of footwear (current footwear not

supportive)

3 Prescribed orthotics from podiatrist 0

53 Feet swelling; restricted movement and

pain

2 3 3 No No 12 1 4 Participant already seeing GP. Added

ankle ROM exercise to help with swelling

4 NA 0

53 Pain with neck flexion 1 3 3 No No 12 1 2 Participant to see GP; currently on anti-

inflammatory medication.

4 NA 0

54 Appendicitis and surgery for appendicitis 3 4 3 Yes Yes 6 3 5 Participant advised by her GP and

oncologist to not exercise until they give

approval.

2 Surgery 35

59 Light-headedness during exercise. 1 3 4 No No 6 1 3 Rested from exercise (10 min. break with

drink of water). Proceeded with seated

exercises (i.e., avoided standing

exercises).

3 Resolved 0

59 Dizziness during exercise (participants

did not eat breakfast or dinner).

1 3 3 No No 8 1 3 Ceased exercise as participant had not

eaten breakfast or dinner; education on

hypoglycaemia; advised participant to eat

breakfast.

3 Participant feeling better but still

experience some fatigue after meal

0

1 Adverse Event (AE) Grade: 1=Mild (minimal disruption to Activities of Daily Living); 2=Moderate (disruption to Activities of Daily Living) 3= Severe (complete disruption to self-care Activities of Daily Living) 4= Life Threatening or Disabling. 2 Relationship of event to Exercise Intervention: 1 = Participant (only the participant thinks this event is related to the intervention); 2= AEP (Only the AEP thinks this event is related to the intervention); 3= Both (Both the AEP and participant think this event is related to the

intervention); 4= Neither (Neither the participant or AEP think this event is related to the intervention). 3 Relationship of event to Non-study related factors (housework, gardening, shopping, normal work activities): 1 = Participant (only the participant thinks this event is related to the intervention); 2= AEP (Only the AEP thinks this event is related to the intervention); 3= Both

(Both the AEP and participant think this event is related to the intervention); 4= Neither (Neither the participant or AEP think this event is related to the intervention). 4Is this event a Serious AE (Resulted in death, disability or hospitalisation): Yes, or no 5 Did the AE result in a hospitalisation? Yes, or no. 6 Stage of Intervention: Number of weeks since baseline. 7 Impact on Intervention; 1=Minor (required no change to exercise intervention or prescription.); 2=Moderate (Required some modification to the exercise intervention or prescription. e.g. Participant could still complete exercise sessions but exercise prescription was adjusted, or, ≤1

week of sessions were missed.); 3= Major (Required major modification to the exercise intervention or prescription. e.g. Participant required a period of absence from exercise for ≥1). 8 Recommendations:

1 = Nil; 2 = No change in exercise prescription but referred to GP / other; 3 = Changed exercise prescription but no referral; 4 = Changed exercise prescription but referred to GP / other; 5 = Cease exercise until clearance by GP / other. 9 Present Status of adverse event: 1= Not recovered or not resolved; 2= Recovered or resolved with sequelae; 3 = Recovered or resolved without sequelae; 4= Other, specify. 10 Duration of adverse event: Number of days; note: 0 days = resolved within the same day.

4.13 APPENDIX J: BOX PLOTS SHOWING MEDIAN AND INTERQUARTILE RANGES OF MINUTES PER WEEK OF

MODERATE INTENSITY AEROBIC AND RESISTANCE EXERCISE (RATING OF PERCEIVED EXERTION: 12 TO 14)

THAT WAS PERFORMED DURING EACH OF THE 12 WEEKS

Week

Min

ute

s p

er

wee

k o

f m

od

era

te

inte

ns

ity e

xe

rcis

e

281

4.14 APPENDIX K: PHYSICAL ACTIVITY COUNSELLING BOOKLET (“STAYING ACTIVE AFTER SAFE”)

289

4.15 APPENDIX L. OVERVIEW OF THE THEORY OF PLANNED

BEHAVIOUR CONSTRUCTS AND SUMMARY OF HOW THEY

WERE IMPLEMENTED INTO THE BOOKLET (“STAYING ACTIVE

AFTER SAFE”)

Normative, behavioural, and control beliefs [230] were integrated in the development

of the “Staying active after SAFE”. An overview of these constructions is shown in

Table 4.14.1 (below). Based on recommendations for addressing the Theory of

Planned Behaviour (TPB) constructs to support breast cancer survivors’ participation

in exercise and physical activity, the physical activity booklet addressed and

implemented the following [244]:

1) An individual’s attitudes can be influenced by providing intervention materials

designed to assist in addressing the breast cancer patients and survivor’s

behavioural beliefs. Common behavioural beliefs in breast cancer patient’s

survivors of cancer are that exercise maintenance can lead to long-term benefits

[244]. Therefore, components of the booklet included long-term benefits of

exercise, both in terms of general health and breast cancer-specific benefits,

and provided activities to ensure participants can identify, engage with and

reflect on personal benefits [244].

2) In relation to subjective norm, it is important for AEPs to encourage long-term

exercise and physical activity maintenance and inform patients the current

exercise and physical activity recommendations for individuals with breast

cancer [244]. Furthermore, the physical activity counselling session and

booklet contained items/activities to identify the possibility of seeking exercise

support from family and friends to encourage and support exercise

participation [244].

3) In terms of perceived behavioural control, AEPs targeted both general and

breast cancer-specific control beliefs that the survivors of cancer may have

[244]. For example, common control beliefs related to exercise participation in

women with breast cancer are exercise barriers, such as fatigue and lack of

time. As such, to address this component of the TPB, the physical activity

counselling session and booklet contained items/activities where participants

identified personal control beliefs (e.g., barriers) and problem-solving

activities, and guidance (tips) in how these may be overcome to help the

participants develop strategies to overcome these barriers, which can have

positive influence on their perceived behavioural control [244].

Table 4.14.1 Overview of Theory of Planned Behaviour constructs.

TPB construct Overview of construct

Intention

(including

intention

formulation and

implementation

The theory proposes that:

• Intention is the main determinant of human behaviour, which has 2 components: 1) a

behaviour choice or goal (i.e., what and individual intends to do) and: 2) intention

strength (i.e., how motivated an individual is to undertake that behaviour) [243, 310].

• Intentions are personal judgments about an individual’s future behaviour (i.e., whether

they plan to engage in a certain behaviour [243, 311, 312].

• An individual’s intention to participate in a behaviour in influenced by the individual’s:

- Attitude

- Subjective norm

- Perceived behavioural control

Attitudes • An individual’s personal beliefs are influenced by the perceived advantages and

disadvantages of engaging in the behaviour (behavioural beliefs) [243, 313-315].

• Perceived outcomes of engaging in the behaviour, and evaluation of these outcomes are

vital to the individual’s attitude towards the behaviour [243, 316].

• Attitudes includes both:

- Affective components (which is the expected enjoyment/ non-enjoyment or

unpleasantness/ pleasantness of the behaviour i.e., the positive or negative attitude

of participating in the behaviour) [310]and

- Instrumental components (which is the expected benefit or harms of the

participating in the behaviour) [284, 317]

Subjective norm • Subjective norm reflects an individual’s perceptions of social approval for participating

in the behaviour [318]. It is the perceived social pressure that an individual feels to

participate (or not) in the behaviour and expected support for the behaviour.

• Subjective norms relate to the beliefs of whether the individual believes that other

important individuals want them to participate in the behaviour, and whether these other

individuals participate in the behaviour themselves (normative beliefs) [243, 310, 319].

• Subjective norm includes both:

- Injunctive (subjective, i.e., how others’ view the engaging in the behaviour) and

descriptive components (i.e., how others’ behaviour influences the individual’s

performance [284, 320].

• In elderly populations, friends, family members, treating health professionals, and co-

workers have been identified as significant individuals whose views are important for

engaging a behaviour [223, 224, 229, 314, 321].

Perceived

behavioural

control

• The perceived ease or difficulty of undertaking a behaviour which includes includes self-

efficacy (e.g., the belief that an individual is capable of undertaking a behaviour) and

perceived control (e.g., personal control over the behaviour) [223, 224].

• Control beliefs are the basis for perceived behavioural control. Control beliefs are factors

such as opportunities, availability and access to resources and facilities that are

considered important for participating in the behaviour [243].

• Availability and access to more resources and opportunities, and minimal barriers are

determinants that results in greater perceived control over the behaviour [223, 224, 243,

310, 314, 322, 323].

291

4.16 APPENDIX M. DESCRIPTION OF THE BOOKLET COMPONENTS AND THEORY PLANNED BEHAVIOUR

CONSTRUCTS THAT EACH COMPONENT ADDRESSED.

Table 4.15.1. An overview of sections and content within the physical activity booklet and their underlying Theory Planned Behaviour theoretical constructs

Booklet section

overview (page

numberin boklet)

Summary of primary content Questions or activities for participant to complete Related TPB constructs and

targeted beliefs

Section 1:

Introduction and

benefits (p. 2-3)

• Overview of general and breast cancer-related health benefits becoming,

and staying physically active during and following treatment; identifying

personal health benefits of exercise

• How can staying active benefit me? (p. 2)

• Can you think of any other benefits that may be important to you?

• How would continuing to be physically active improve your life?

Attitudes

Behavioural beliefs

Benefits of longer

physical activity and

staying active (p. 3)

• Overview of short-, medium- and long-term benefits of physical activity.

• To provide specific, personalised information relevant to the participant.

• To go beyond simply presenting physical activity summary information;

provide interpretation of personal physical activity health benefits that

are specific to the participant’s health concerns and cancer experience.

• Tick the boxes (health benefits) that are important to you Attitudes

Behavioural beliefs

Section 2:

How much physical

activity should I

continue to do? (p. 4)

• Overview of frequency, intensity, time and type of physical activity (to

provide participants with exercise guidelines and recommendations).

• None (information only) Attitudes

Behavioural beliefs

Intention

Box 1:

Incidental physical

activity (p. 4)

• Information of integrating other forms of physical activity in daily lives

(i.e., non-structured exercise).

• None (information only) Control beliefs

Section 3:

Exercise guidelines (p.

4)

• Information about current aerobic and resistance exercise

recommendations for cancer populations (frequency, intensity, time,

type).

• None (information only) Attitudes

Behavioural beliefs Intention

Section 4:

Intention to maintain

physical activity (p. 5)

• Addressing intention to maintain physical activity over the next 12

weeks and beyond.

• How do you intend to remain physically active over the next 12 weeks

(that is, continue to perform 150 minutes per week of moderate

intensity physical activity?

• I intend to exercise at least ____ times per week over the next 12

weeks for _____ minutes.

• How do you intend to remain physically active beyond the next 12

weeks (that is, continue to perform 150 minutes per week of moderate

intensity physical activity?

Intention

Section 5:

Motivation (p. 6–7) • Identifying reasons and finding the motivation to remain physically

active.

• If you remain physically active during the next 12 weeks, what

benefits might you experience?

• If you continue to be physically active what benefits might you

experience in 5 years?

• What is one of the major benefits that you could experience if you

remain physically active during the next 12 weeks and beyond?

• Below, write down what could motivate you to remain physically

active during the next 12 weeks and beyond.

Subjective norm

Normative beliefs

Intention

Perceived behavioural control

(self-efficacy and controllability)

Box 2: • Behavioural beliefs

Identifying

motivational factors (p.

6)



Box 3:

Motivation • Tips to overcome a lack of motivation (p. 7). • None (information only) Behavioural beliefs



Section 6:

Planning (p. 8–9) • Making a physical activity plan (p. 8): allow the participants to

independently develop a physical activity–related goal that can be

progressed over time.

• Why is physical activity important to me?

• What type of physical activity do I want to do?

• Where would I do the activity?

• When can I be active?

• Create an individualised plan.

Intention implementation (goal

setting)

Box 4:

Physical activity

maintenance (p. 9)

• Tips to maintain physical activity participation (p. 9). • None (information only). Control beliefs

Section 7:

Goal setting (p. 10-12) • Setting physical activity goals (SMART goal setting);

• Allow participants to reflect on personal values during goal setting and

the potential outcomes of behaviour change from multiple perspectives

(Robertson 2017 ref); encourage participants to create value-based goals

for physical activity.

• What physical activities or exercises are you currently doing?

• How often during do you exercise? (Once a week? Twice a week?

Daily?)

• How long are your physical activity sessions? (15 minutes or less?

Only a few minutes each time? 30 minutes or more?).

• Example SMART goal.

• Create a SMART goal.

Intention implementation (goal

setting)

Planning

Section 8a:

Barriers (p. 13-14) • Identifying barriers to your physical activity participation.

• Information on breast cancer-related barriers to physical activity

participation (fatigue, motivation, self-image or feelings of discomfort

exercising in public).

• To assist participants to independently overcome common barriers by

offering suggestions.).

• Example list of common barriers and tips on how they can overcome

them

• What are barriers to my own physical activity participation?

• What is the barrier?

• How can I overcome it?

Control beliefs

Self-efficacy

Controllability

Section 8b:

Personal barriers (p.

15)

• Provide an opportunity to address personal physical limitations and

health concerns.

• None (information only). Control beliefs

Box 5:

Exercise and physical

activity safety (p. 15)

• Exercise safety guidelines. • None (information only). None

293

4.17 APPENDIX N: FITBIT FEASIBILITY QUESTIONNAIRE

Date __ / __ / ____ Participant ID _____________

Survey Instructions:

Thank you for taking the time to complete this survey. The following questionnaire is

about your use and experience of the Fitbit during the study. Below is a list of

instructions that should help make this task easier:

• Please answer all of the sections in the survey. If you are not sure of the

correct answer, please give us your best estimate.

• To reduce the time required to complete the survey, we have used boxes

that can be marked for your answers. Simply respond to the question by

placing a tick in the box that corresponds to your answer. There are some

questions which will require a short written answer, but these have been

kept to a minimum. The questionnaire should take approximately 10

minutes to complete.

• Sometimes your answer to one question will allow you to skip over other

questions. Please read the ‘go to’ statements carefully to make sure that you

answer all the appropriate questions. If at any time you are uncertain about

what to do, or cannot answer a question, just leave it until we talk to you

and we will help you at that time. Otherwise you can phone Ben Singh, the

Project Coordinator on 3138 3506.

• A fully completed survey will provide us with valuable information. However,

if you are uncomfortable answering certain questions, you are able to skip

these, and move on to the next. An incomplete survey will still be of use to

us.

1) Regardless of whether you chose to use the Fitbit during the study, do you think an exercise-tracking device such as the Fitbit may:

No, not at all

No, not really Yes, somewhat

Yes, very much

help you become more physically active?

⃝ ⃝ ⃝ ⃝

help you remain physically active?

⃝ ⃝ ⃝ ⃝

have no effect on your physical activity levels?

⃝ ⃝ ⃝ ⃝

cause you to reduce your physical activity levels?

⃝ ⃝ ⃝ ⃝

2) Did you use the Fitbit given to you during the study? No ⃝

Yes ⃝

If you answered “No”, please go to Question 3. If you answered “Yes”, please go to Question 4

3) Given that you did not use the Fitbit given to you during the study, please briefly state the reasons why you did not use it:

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________________________________ Please go to Question 18.

4) Given that you used the Fitbit given to you during the study, please briefly state the reasons why you used it:

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________________________________

5) The following questions relate to your use of the Fitbit during the study. During the 12 weeks, how often did you wear the Fitbit?

Never ⃝

Irregularly ⃝

Most of the time ⃝

Always ⃝

6) If you did not wear the Fitbit on some days, why? Tick all that apply.

⃝ I forgot to wear it that day. ⃝ The device was not charged (low battery). ⃝ Due to work (e.g., I must remove jewellery or watches at work). ⃝ I didn’t want to wear it that day for a particular reason (e.g., due to a special occasion). ⃝ It was uncomfortable to wear and/or skin irritation. ⃝ I felt like I was not getting any benefit from wearing it. ⃝ Other reason. Please specify. _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

295

_____________________________________________________________________________________

7) In a typical week, how many days did you wear the Fitbit? ________days per week

8) In a typical day (24 hour period), how many hours did you wear the Fitbit?

________hours per day

9) Did using the Fitbit help to increase your exercise participation during the 12 week period? Please tick one response

No ⃝

Maybe ⃝

Somewhat ⃝

Very much ⃝

10) Did using the Fitbit assist you with monitoring (keeping track of) your exercise? Please tick one response

No ⃝

Maybe ⃝

Somewhat ⃝

Very much ⃝

11) Did using the Fitbit assist with meeting your exercise participation targets during the study (i.e., meeting you goal of 150 minutes of moderate-intensity exercise each week)? Please tick one response

No ⃝

Maybe ⃝

Somewhat ⃝

Very much ⃝

12) How much do you agree with the following statement? In the previous 7 days, what impact did the Fitbit have on your physical activity levels?

Strongly agree Agree Disagree Strongly disagree

an increase in your physical activity

⃝ ⃝ ⃝ ⃝

a decrease in your physical activity

⃝ ⃝ ⃝ ⃝

a maintenance of physical activity

⃝ ⃝ ⃝ ⃝

13) The following questions relate to viewing your data on the Fitbit display screen (on the device itself). In a typical day, how often did you look at the Fitbit display screen to check:

Didn’t look at it

1-3 times per day

4+ times per day

how many steps you’ve taken ⃝ ⃝ ⃝

your current heart rate ⃝ ⃝ ⃝

the number of calories you’ve burned

⃝ ⃝ ⃝

the distance you’ve travelled ⃝ ⃝ ⃝

the number of flights of stairs you’ve climbed

⃝ ⃝ ⃝

14) When you looked at the Fitbit display screen, why were you interested in looking at the screen? Tick all that apply.

297

⃝ I wanted to know if I had reached my daily goal. ⃝ I wanted to know how much physical activity I had done that day. ⃝ I wanted to know if I had increased physical activity levels from yesterday/last week. ⃝ I was interested in looking at my physical activity (i.e., steps/heart rate/calories/distance/flights of stairs) during exercise. ⃝ I was interested in looking at my physical activity (i.e., steps/heart rate/calories/distance/flights of stairs after exercise). ⃝ Other reason. Please specify. ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

End of questionnaire.

15) The following questions relate to uploading and viewing your data (e.g., either on a computer, smartphone, or tablet). During the study, did you:

No, never (0 times)

Irregularly (1 to 5 times during the 12

weeks)

Yes, sometimes (approximately

once per fortnight)

Yes, always (at least once

per week)

a. upload your data (e.g., onto a computer or phone)

⃝ ⃝ ⃝ ⃝

b. view your data on a computer or smart device (e.g., look at your graphs)

⃝ ⃝ ⃝ ⃝

16) If you did upload your Fitbit data, why? Tick all that apply.

⃝ I was interested in looking at my daily/weekly graphs in more detail. ⃝ I was interested in looking at my progress over the 12 weeks. ⃝ I found the graphs an easy way to monitor my daily/weekly physical activity. ⃝ Other reason. Please specify. _____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

17) The following questions relate to your experiences of using the Fitbit during the previous 12 weeks

No, not at all

No, not really

Yes, somewhat

Yes, very much

Did you find the Fitbit easy to use? ⃝ ⃝ ⃝ ⃝

Did you find the Fitbit comfortable to wear?

⃝ ⃝ ⃝ ⃝

Overall, were you satisfied with the Fitbit in assisting you to meet your weekly exercise participation targets?

⃝ ⃝ ⃝ ⃝

18) What did you like about the Fitbit?

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

19) What did you dislike about the Fitbit or what would you change about the Fitbit?

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

20) Would you use a Fitbit in the future? ⃝ Yes

⃝ No

299

Thank you for participating in the study and completing this survey!

4.18 APPENDIX O: DETAILED FITBIT FEASIBILITY RESULTS

Question 1

No, not at

all,

n (%)

No, not

really,

n (%)

Yes,

somewhat,

n (%)

Yes, very

much,

n (%) Do you think an exercise-tracking

device (e.g., a Fitbit or Garmin)

may:

help you become more physically

active?

0 (0%) 5 (19.2%) 11 (42.3%) 10 (38.5%)

help you remain physically

active?

0 (0%) 5 (19.2%) 12 (46.2%) 9 (34.6%)

have no effect on your physical

activity levels?

8 (30.8%) 10

(38.5%)

7 (26.9%) 1 (3.8%)

cause you to reduce your physical

activity levels?

16 61.5%) 8 (30.8%) 2 (7.7%) 0 (0%)

Question 2

No,

n (%)

Yes,

n (%) Did you use an exercise tracker (e.g., a Fitbit or Garmin)

during the past 12 weeks? 0 (0%)

26 (100.0%)

Question 3

Never,

n (%)

Irregularly,

n (%)

Most of

the time, n

(%)

Always, n

(%)

Do you think an exercise-tracking

device (e.g., a Fitbit or Garmin) may help you become more physically

active?

0 (0%) 5 (19.2%) 10

(38.5%)

11

(42.3%)

Question 4 In a typical week, how many days did you wear

an exercise tracker? Mean (SD): 6.9 (1.4) days

Median (min, max): 7. (1, 7) days

In a typical day (24-hour period), how many

hours did you wear an exercise tracker? Mean (SD): 17.3 (5.6) hours

Median (min, max): 16 (9, 24) hours

Question 5

No, n

(%)

Maybe,

n (%)

Somewhat,

n (%)

Very

much, n

(%) Did using an exercise tracker help to

increase your exercise participation

during the past 12 weeks?

3

(11.5%)

5

(19.2%)

12 (46.2%)

6 (23.1%)

301

Did using an exercise tracker assist

you with monitoring (keeping track

of) your exercise during the past 12

weeks?

2 (7.7%)

3

(11.5%)

9 (34.6%)

12

(46.2%)

Did using an exercise tracker assist

with meeting your exercise

participation targets during the past

12 weeks (i.e., meeting you goal of

150 minutes of moderate-intensity

exercise each week)?

3

(11.5%)

4

(15.4%)

14 (53.8%)

5 (19.2%)

Question 6

Strongly

agree, n

(%)

Agree, n (%) Disagree, n

(%)

Strongly

disagree,

n (%) How much do you agree with the

following statement? In the

previous 7 days, what impact did

the use of an exercise tracker

have on your physical activity

levels?

An increase in your physical

activity

5 (19.2%) 15 (57.7%) 4 (15.4%) 2 (7.7 %)

A decrease in your physical

activity

2 (7.7%) 1 (3.8%) 13 (50.0%) 10

(38.5%)

A maintenance of physical

activity

3 (11.5%) 16 (61.5%) 5 (19.2%) 2 (7.7%)

Question 7

Didn’t look

at it, n (%) 1-3 times

per day, n

(%)

4+ times

per day, n

(%)

N/A, n

(%)

The following questions relate to

viewing your data collected by

your exercise tracker. In a typical

day, how often did you look at

your exercise tracker display

screen to check:

How many steps you’ve taken 2 (7.7%) 9 (34.6%) 15 (57.7%) 0 (0%)

Your current heart rate 7 (26.9%) 9 (34.6%) 9 (34.6%) 1 (3.8%)

The number of calories you’ve

burned

15 (57.7%) 4 (15.4%) 7 (26.9%) 0 (0%)

The distance you’ve travelled 6 (23.1%) 11 (42.3%) 9 (34.6%) 0 (0%)

The number of flights of stairs

you’ve climbed

9 (34.6%) 7 (26.9%) 8 (30.8%) 2 (7.6%)

Other 0 (0%) 1 (3.8%) 4 (15.4%) 20

(80.8%)

Question 8

When you looked at exercise tracker display screen, why were you

interested in looking at the screen? Tick all that apply. Yes, n (%)

I wanted to know if I had reached my daily goal. (73.1%) I wanted to know how much physical activity I had done that day. 19 (73.1%) I wanted to know if I had increased physical activity levels from

yesterday/last week. 12 (46.2%)

I was interested in looking at my physical activity (i.e., steps/heart

rate/calories/distance/flights of stairs) during exercise. 15 (57.7%)

I was interested in looking at my physical activity (i.e., steps/heart

rate/calories/distance/flights of stairs after exercise). 14 (53.8%)

Other reason. Please specify. 3 (11.5%)

Question 9

No,

never

(0 times),

n (%)

Irregularly

(1 to 5

times

during the

12 weeks),

n (%)

Yes,

sometimes

(approximately

once per

fortnight), n

(%)

Yes,

always

(at least

once per

week), n

(%)

NA, n

(%)

During the study, did

you:

a. Upload your data

(e.g., onto a computer

or phone)

5

(19.2%)

7 (26.9%) 3 (11.5%) 11

(42.3%) 0 (0%)

b. View your data on

a computer or smart

device (e.g., look at

your graphs)

6

(23.1%)

5 (19.2%) 3 (11.5%) 10

(38.5%)

2 (7.7%)

Question 10

Yes, n (%)

If you did upload your exercise tracker data, why? Tick all

that apply.

I was interested in looking at my daily/weekly graphs in more detail. 17 (65.4%) I was interested in looking at my progress over the 12 weeks 14 (46.2%) I found the graphs an easy way to monitor my daily/weekly physical

activity.

10 (38.4%) Other reason. 4 (15.4%)

Question 11

No, not at

all, n (%) No, not

really, n

(%)

Yes,

somewhat,

n (%)

Yes,

very

much, n

(%) The following questions relate to

your experiences of using your

exercise tracker during the

previous 12 weeks

303

Did you find your exercise tracker

easy to use?

1 (3.8%) 1 (3.8%) 9 (34.6%) 15

(57.7%)

Did you find your exercise tracker

comfortable to wear?

0 (0%)

4 (15.4%)

10 (38.5%)

12

(46.2%)

Overall, were you satisfied with

your exercise tracker in assisting

you to meet your weekly exercise

participation targets?

0 (0%)

2 (7.7%)

11 (42.3%)

13

(50.0%)

Question 12 Yes, n (%) No, n (%) Would you use an exercise tracker in the future? 25 (96.2%) 1 (3.8%)

EXERCISE SAFETY ROLE OF FITBITS AMONG WOMEN WITH … · The third component of this PhD research...

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