Post on 15-Jul-2020
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
Chapter 1: Introduction 23
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
24 Chapter 1: Introduction
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)
Chapter 1: Introduction 25
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
26 Chapter 1: Introduction
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].
Chapter 1: Introduction 27
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)
• Hormonal therapy
• Targeted therapy
III IIIA and Operable IIIC:
• Mastectomy followed by radiation therapy
• Lumpectomy plus radiation therapy following chemotherapy
• Chemotherapy (almost always recommended)
• Hormonal therapy
• Targeted (endocrine) therapy
IIIB and Inoperable IIIC:
• Chemotherapy followed by mastectomy and radiation
• Chemotherapy (almost always recommended)
• Hormonal therapy
• Targeted therapy
IV • Surgery, radiation therapy, or both
• Chemotherapy (almost always recommended)
• Hormonal therapy
• Targeted therapy
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,
28 Chapter 1: Introduction
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
Chapter 1: Introduction 29
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.
30 Chapter 1: Introduction
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:
Chapter 1: Introduction 31
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
32 Chapter 1: Introduction
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].
Chapter 1: Introduction 33
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
34 Chapter 1: Introduction
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
Chapter 1: Introduction 35
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
36 Chapter 1: Introduction
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
Chapter 1: Introduction 37
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
38 Chapter 1: Introduction
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.
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 41
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
42 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 43
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.
44 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
2.2.10 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=
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 45
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
46 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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,
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 47
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.
48 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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%.
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 49
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
50 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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.
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 51
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.
52 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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),
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 53
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
54 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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.
2 1 session/week supervised (2 of 5), 2 sessions/week unsupervised.
3 to 4 3 sessions/week unsupervised.
5 1 session/week supervised (3 of 5), 2 sessions/week unsupervised.
6-7 3 sessions/week unsupervised.
8 1 session/week supervised (4 of 5), 2 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.
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 55
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.
56 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 57
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.
58 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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.
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 59
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.
60 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 61
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
62 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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).
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
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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.
64 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 65
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
66 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
[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).
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II+ breast cancer (Study 1, the SAFE study) 67
• 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
68 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 69
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;
70 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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).
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II+ breast cancer (Study 1, the SAFE study) 71
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.
72 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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Figure 2.1 Study CONSORT flow diagram
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
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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.
74 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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).
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 75
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.
76 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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.
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
II+ breast cancer (Study 1, the SAFE study) 77
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]
Grade 3 adverse events (n=0) Grade 3 adverse events (n=3)
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]
Grade 4 adverse events (n=0) Grade 4 adverse events (n=1)
Nil • Disease progression (n=1) [Neoplasm,
malignant]
Grade 5 adverse events (n=0) Grade 5 adverse events (n=0)
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.
78 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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
Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage
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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
80 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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.
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2.8.1.4 Secondary outcomes
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.
86 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
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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.
88 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage II+ breast cancer (Study 1, the SAFE study)
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)
Change from baseline to 12 weeks
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.
PROMIS: Patient-Reported Outcomes Measurement Information System.
ǂ Represents a clinically relevant change.
89
Exercise self-efficacy
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).
90 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with stage II+ breast cancer (Study 1, the SAFE study)
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.
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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.
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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
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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
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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.
2.9.1.6 Secondary outcomes
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
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(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
102 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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
104 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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,
106 Chapter 2: The safety, feasibility and effectiveness of a translational exercise intervention for women with
stage II+ breast cancer (Study 1, the SAFE study)
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
107
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.
109
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.
112 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)
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
114 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)
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
116 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)
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
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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=
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–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
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counselling alone on physical activity maintenance (Study 2, the SAFE-Maintain study)
$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].
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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
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counselling alone on physical activity maintenance (Study 2, the SAFE-Maintain study)
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
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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.
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counselling alone on physical activity maintenance (Study 2, the SAFE-Maintain study)
• 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;
127
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
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counselling alone on physical activity maintenance (Study 2, the SAFE-Maintain study)
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
129
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
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counselling alone on physical activity maintenance (Study 2, the SAFE-Maintain study)
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
131
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].
132 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)
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
134 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)
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:
135
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-
136 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)
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.
138 Chapter 3: The effect of a physical activity counselling session plus a Fitbit versus physical activity
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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
140 Chapter 3: The effect of a physical activity counselling session plus a Fitbit versus physical activity
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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)
Median (minimum, maximum)
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%)
142 Chapter 3: The effect of a physical activity counselling session plus a Fitbit versus physical activity
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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)
Median (minimum, maximum)
3.5 (1.7)
4 (1, 8)
2.5 (1.7)
2 (0, 6)
Overall symptom severity2
Mean (SD)
Median (minimum, maximum)
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)
Median (minimum, maximum)
113.6 (101.5)
60.0 (0.0, 480.0)
122.1 (100.9)
120.0 (0.0, 375.0)
Total activity6
Mean (SD)
Median (minimum, maximum)
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.
144 Chapter 3: The effect of a physical activity counselling session plus a Fitbit versus physical activity
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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.
PAC: Physical activity counselling group.
PAC+F: Physical activity counselling plus Fitbit group.
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).
MVPA: Moderate-to-vigorous physical activity.
PAC: Physical activity counselling group.
PAC+F: Physical activity counselling plus Fitbit group.
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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).
MVPA: Moderate-to-vigorous physical activity.
PAC: Physical activity counselling group.
PAC+F: Physical activity counselling plus Fitbit group.
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.
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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.
PAC: Physical activity counselling group.
PAC+F: Physical activity counselling plus Fitbit group.
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)
Change from baseline to 12 weeks
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).
PAC: Physical activity counselling group.
153
PAC+F: Physical activity counselling plus Fitbit group.
PROMIS: Patient-Reported Outcomes Measurement Information System.
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Exercise self-efficacy
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).
PAC: Physical activity counselling group.
PAC+F: Physical activity counselling plus Fitbit group.
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.
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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.
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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.
3.11.2.2 Secondary outcomes
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
160 Chapter 3: The effect of a physical activity counselling session plus a Fitbit versus physical activity
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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
162 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)
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
164 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)
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
166 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)
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
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197
Appendices
4.4 APPENDIX A: SYSTEMATIC REVIEW AND META-ANALYSIS
MANUSCRIPT
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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
249
251
253
255
4.8 APPENDIX E: CASE MANAGEMENT FOLDER (USED BY THE EXERCISE PHYSIOLOGIST)
257
259
261
263
265
267
269
4.9 APPENDIX F: PARTICIPANT EXERCISE LOGBOOK
271
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)
Continuous t-test or Wilcoxon sign-rank
tests
2 repetitions [165]
6. Balance Single leg stance test (total duration,
seconds)
Continuous t-test or Wilcoxon sign-rank
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)
Continuous t-test or Wilcoxon sign-rank
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
PROMIS: Patient-Reported Outcomes Measurement Information System.
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”)
283
285
287
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)
Perceived behavioural control
(self-efficacy and controllability)
Box 3:
Motivation • Tips to overcome a lack of motivation (p. 7). • None (information only) Behavioural beliefs
Perceived behavioural control
(self-efficacy and controllability)
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%)