Ashley Leak Bryant PhD, RN-BC, OCN Assistant Professor, School of Nursing

Lineberger Comprehensive Cancer Center

February 9, 2016

Challenges  and  OpportuniDes  in  ConducDng  an  InpaDent  Exercise  IntervenDon  for  Adults  with  Acute  Leukemia:      

Exercise  and  Quality  of  Life  in  Adults  with  Acute  Leukemia  (EQUAL)    

•  EsDmated  new  leukemia  cases  for  2016:  60,140  

•  EsDmated  new  acute  leukemia  cases  for  2016:  26,540  

•  5  year  survival  for  AML:20-­‐30%  

•  5  year  survival  for  ALL:60-­‐80%    •  In  2012,  there  were  an  esDmated  

318,389  people  living  with  leukemia  in  the  United  States.  

•  In  2016,  1,408  people  will  be  diagnosed  with  leukemia;  760  projected  to  die  in  NC.  

Symptoms  and  QOL  

•  Most  commonly  assessed  symptoms  in  acute  leukemia  populaDon    –  FaDgue  –  Anxiety  –  Depression  

•  FaDgue  can  have  negaDve  impacts  on  QOL  – FuncDonal  decline  – Social  isolaDon                                              Bryant  et  al  2015;  Bryant,  Walton,  &  Phillips,  2015  

Acute  Leukemia  InpaDent  Exercise  Studies  (n=5)  Author/Year     Sample  

Size  Aerobic  Exercise   Intensity  &  Measurement   Symptom  

Outcomes    

Chang  et  al,  2008  (RCT)  

22   Walking  in  hallway     12  min,  5  Dmes/week        FaDgue,  Anxiety,              Depression      

   QOL,  EmoDonal            FuncDon  

Ba]aglini  et  al,  2009  (non-­‐RCT)  

10   2  sessions  (AM  &  PM)  5-­‐10  min  cycle  or  treadmill  5-­‐15min  resistance  5-­‐10min  core  

3-­‐4  Dmes/week  for  3-­‐5  weeks        FaDgue,  Anxiety,            Depression                QOL  

Klepin  et  al,  2011  (non-­‐RCT)  

24   5-­‐15min  walking  15min  strength  &  flexibility    5-­‐15min  walking  

3  Dmes/week  for  4  weeks  offered  Intensity:  Mild  (walking)  

   Depression          QOL  

Alibhai  et  al,  2012  (non-­‐RCT)  

35   10-­‐40min  walk  or  bike  10-­‐25min  resistance  5-­‐10min  flexibility    

4-­‐5  Dmes/week  during  inducDon  treatment  Intensity:  Light  to  moderate  

   FaDgue,  Anxiety,                          Depression      QOL  

Jarden  et  al,  2013  (non-­‐RCT)  

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StaDonary  cycling  Dynamic  and  resistance  training  RelaxaDon  training  Walk  program  with  step  counter        Health  counseling  

6  week  exercise  program    20  min/session  with  or  without  rest  intervals,  3  days/week  20  min/session,  3  days/week  20min/session,  3  days/week      1  day/week    

       QOL,  mental  health,  vitality          symptom  burden  and  symptom  interference  

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•  Primary  Objec*ve:  –  Compare  faDgue  scores  between  the              intervenDon  and  control  groups  Secondary  Objec*ves:    –  Compare  symptoms  of  anxiety,  depression,  sleep  disturbances,  and  quality  of  life  (physical  and  mental  changes)  

–  Compare  cardiovascular  funcDon,  strength,  body  composiDon,  funcDonal  mobility,  and  muscle  size  

–  Feasibility  of  collecDng  blood  for  IL6,  IL10,    and  p16  

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Opportunity  1  

Characteristics of the Individual

Biological and

Physiological Factors

Symptom Status

Functional Status

General Health

Perceptions

Overall quality of

life

Characteristics of the Environment

Conceptual Model of Health and QOL Domains

Wilson, J.B., & Cleary, P.D. (1995). Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA, 273(1): 59-65. Ferrans, C.E., Zerwic, J.J., Wilbur, j.E., & Larson, J.L. (2005). Conceptual model of health-related quality of life.. Journal of Nursing Scholarship, 37(4), 336-342.

non-medical factors

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EQUAL  Study  Criteria    Inclusion    

•  Newly  diagnosed  with  acute  leukemia  (ALL  or  AML)  

•  Admi]ed  for  inducDon  chemotherapy    

•  Expected  hospital  stay  of  3-­‐4  weeks  or  longer  

•  Age  >21  years  of  age  •  Ability  to  understand  and  

speak  English    

Exclusion    

•  Acute  or  chronic    –  Cardiac  disease  –  respiratory  disease  –  Bone,  joint  ,  or  muscular  

abnormaliDes    

•  Previous  cancer  •  AcDve  bleeding,  acute  

thrombosis,  ischemia,  hemodynamically  unstable  or  uncontrolled  pain  

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EQUAL  Study  Plan  

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EQUAL  IntervenDon  Components  

•  4  week  in-­‐hospital  aerobic  and  strength  training    

•  4  days  a  week  (Mon,  Tues,  Thurs,  Fri)  •  AM  and  PM  sessions  •  20-­‐30  minutes  each  session  

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Characteristics of the Individual *Demographic (age, gender, marital)

* Clinical (type of leukemia)

Biological and Physiological Factors

*Comorbidities

Symptom Status *Fatigue *Anxiety

*Depression *Sleep Disturbances

Functional Status

*KPS

General Health Perceptions

*Social Support

Overall quality of life

*SF-12

Characteristics of the Environment

*Inpatient oncology unit

Measures of QOL Domains

Wilson, J.B., & Cleary, P.D. (1995). Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA, 273(1): 59-65. Ferrans, C.E., Zerwic, J.J., Wilbur, j.E., & Larson, J.L. (2005). Conceptual model of health-related quality of life.. Journal of Nursing Scholarship, 37(4), 336-342.

non-medical factors

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EQUAL  CONSORT  Diagram  March  2014-­‐December  2015      

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Challenge  1  

Demographics   P-­‐value    

Variable   IntervenDon  (n=8)   Control  (n=9)  

Age     52  (13)  Range  34-­‐67  

49(15)  Range  28-­‐69  

0.85  

Gender  

         Male   63   78    0.62  

         Female   37   22  

Race  (%White)     88   78  

EducaDon  (%  beyond  HS  educaDon)  

89   55   0.16  

MarDal  Status  (%  married)     75   78  

FaDgue  

40

42

44

46

48

50

52

54

56

58

60

Baseline Week  4/Discharge

PROMIS  T-­‐Score

Event

PROMIS  Fatigue  T-­‐Scores  Over  Time

Control

Intervention

P<.10  

20  

*Worst is higher number and better is lower number

53  

57  

51  

54  

QOL:  Physical  Health    

35

40

45

50

55

60

Baseline Week  4/Discharge

Physical  Health

 Score

Event

SF12v2  Physical  Health  Scores

Control

Intervention P<.29  

21  

*Better is higher number and worst is lower number

47  

41   41  

38  

QOL:  Mental  Health    

35

40

45

50

55

60

Baseline Week  4/Discharge

Men

tal  H

ealth

 Score

Event

SF12v2  Mental  Health  Scores

Control

Intervention

P<.15  

22  

*Better is higher number and worst is lower number

46  

44  

58  

43  

EQUAL  IntervenDon  Adherence  •  %  sessions  scheduled/completed:  65-­‐92%  

–  *7%  was  outlier,  treatment  side  effects  and  lack  of  interest  –  80%  overall  adherence      

•  Exercise  sessions:  32-­‐50  minutes    •  Canceled  sessions  for  various  reasons  

– GastrointesDnal  issues  (diarrhea,  C.  difficile)  – Fever  – “Not  feeling  well”    

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Feasibility  and  Safety  of    Cardiopulmonary  Exercise  TesDng    (CPET)    •  Highly  sensiDve  measure  •  Cardiac  and  respiratory  systems    •  Assessment  of  peak  oxygen  uptake  

•  Feasibility  defined  as:            -­‐100%  baseline;  50%  post-­‐treatment  

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Opportunity  2  

Is  CPET  Safe  and  Feasible  ?  

•  Baseline  completed:  n=18  (100%  adherence)  •  Post  treatment  completed:  n=9    •  Not  interested,  Dming  conflict,  funcDonal  decline  •  FuncDonal,  relaDvely  healthy  adults  with  acute  leukemia  

•  Not  safe  and  feasible  in  those  with  cardiac  and  respiratory  condiDons  that  may  compromise  tesDng  

•  Resource  driven  and  costly  

EQUAL  Study  Strengths  •  Improved  or  maintained  faDgue  and  mental  health  from  

baseline  to  discharge  for  intervenDon  group  •  Physical  health  was  maintained  for  intervenDon  group  •  Use  of  PROs  (PROMIS)  +  fitness  measures  +  blood    •  Second  acute  leukemia  study  to  test  Vo2*  

             *Alibhai  et  al,  2012  

EQUAL  Study  OpportuniDes  •  Independent  study  for  exercise  sports  science  undergraduate  

and  graduate  students  •  Bre]  Phillips,  MA:  A  Case  Study  on  the  Effects  of  Exercise  on  Muscle  

Cross-­‐SecDonal  Area  during  InducDon  Chemotherapy  for  Acute  Myelogenous  Leukemia  (Study  Coordinator)    

•  ChrisDna  Story,  MA:  Comparison  of  Methods  for  Determining  Aerobic  Exercise  Intensity  using  Heart  Rate  in  Acute  Leukemia  PaDents  prior  to  InducDon  Chemotherapy    (Biological  Research  in  Nursing,  in  press)  

•  Erin  McMullen,  BA:  PredicDng  VO2  TesDng  and  Maximum  Heart  Rate  using  a  Dynamic  Systems  Model  in  Adults  with  Acute  Leukemia  (in  progress)  

•  Lessons  learned  for  future  studies    Opportunity  3  

Perceived  Benefits  and  Barriers  EQUAL  QualitaDve  Data  

•  Aim:  Gain  insight  about  perceived  benefits  and  barriers  to  parDcipaDon  in  an  exercise  intervenDon  during  inducDon  (iniDal)  treatment  

•  6  interviewed  – Semi  structured  interviews  –  Interviewed  24-­‐48  hours  before  discharge  – Audio  recorded  and  transcribed  – Length  of  interviews:  10-­‐28  minutes  

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Opportunity  4  

Findings     Pa*ent’s  Voice  

Benefits  of  Interven*on    

“…exercise  that  I  did,  it  made  me  feel  beKer.”  “…all  these  really  chronic  physical  aches  and  pains  went  away  and  it  is  sort  of  kind  of  same  here  is  I  really  haven’t  felt  any  anxiety  over  this.”  

Structure   “  What  I  liked  best  it  was  structured  exercise  so  that  I  didn’t  have  to  decide.”  “…I’m  a  structured  kind  of  person  and  so  it’s  been  nice  to  have  a  structure  to  kind  of—and  it’s  helped  pass  the  Dme,  to  be  perfectly  honest  with  you.”  

Mo*vator   “It  gives  you  real  power.  It,  um,  it  moDvates  you.”  “It  helped  me  to  believe  that  I  didn’t  have  to  go  and  do  this  on  my  own.”  

Timing  of  Exercise   “...personally  liked  the  least  about  it  was  Dmeframe  in  the  mornings.”  “...and  it  needs  to  be  scheduled.  That  way  you  don’t  have  to  worry  about  any  interrupDons  and  you  don’t  have  to  worry  about  it,  so  you  can  enjoy  it..”  

Post  Hospital  Plan     Gym:  “...I  don’t  think  going  to  my  gym  is  my  best  alternaDve  as  far  as  avoiding  infecDon  and  possible  mold  and  gyms  are  not  necessarily  the  cleanest  places  in  the  world.  I  have  some  minimal  amount  of  home  exercise  equipment  that  I  will  certainly  employ….”  Social  Support:  “…I’ve  got  six  different  people  who  would  be  more  than  happy  to  meet  me  out  there  and  just  hit  the  ball  easy,  former  tennis  partners,  teammates,  stuff  like  that,  all  of  whom  have  been  very  supporDve  of  me  while  I  ‘ve  been  in  here….”   29  

Study  Challenge:  ConDnue  or  Not?    

PROs  •  Increase  sample  size  •  PotenDal  to  show  staDsDcal  

significance  between  groups  as  it  relates  to  faDgue  

 

CONS  •  Heavily  resource  dependent  

on  students  •  Exercise  training  vs  

maintaining/improving  funcDon  

•  Average  1  eligible  paDent  per  month  based  on  current  criteria    

•  Exclusion  criteria  limits  ability  to  recruit  paDents    –  FuncDonal  vs  ill    

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Challenge  2  

Moving  forward…  

•  Feasible,  pracDcal,  scalable  intervenDon  •  Less  resource  driven  

– ParDally  supervised?  – Less  exercise  focus  

•  RN/OT  led  intervenDon  – Aim:  Maintain/improve  funcDon  – ObjecDve  measures  of  physical  acDvity  – Newly  diagnosed  and  relapsed  adults  with  acute  leukemia    

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Opportunity  5  

Acknowledgements    •  John  E.  Ware  and  Alvin  Tarlov  PaDent  Reported  Outcomes  Post-­‐Doctoral  Award    

•  University  Cancer  Research  Fund  start-­‐up  funds  •  NaDonal  Cancer  InsDtute,  Cancer  Care  Quality  Training  Post  Doctoral  Fellowship  (5R25CA116339)    

•  NaDonal  Cancer  InsDtute,  UNC  Oncology  Clinical  TranslaDonal  Research  Training  Program  (NCI  5K12CA120780-­‐07)  

**Thanks  to  the  4  Oncology  pa*ents,  nurses,  and  physicians  for  their  assistance!    

Research  Team    Co-­‐PIs  •  Ashley  Bryant,  PhD,  RN  •  Claudio  Ba]aglini,  PhD  Co-­‐Inves*gators  •  Bryce  Reeve,  PhD  •  Hy  Muss,  MD  •  Ma]hew  Foster,  MD  •  William  Wood,  MD,  MPH  •  Deborah  Mayer,  PhD,  RN  •  Anthony  Hackney,  PhD,  DSc    •  Carly  Sha]en,  MA  •  AnnMarie  Walton,  PhD,  RN  •  Mackenzi  Pergoloz,  PhD,  OTR/L    

Clinical  Research  Coordinator  •  Bre]  Phillips,  MA    

Exercise  Interven*onists  •  Bezna  Junghahn,  BA  •  Chad  Wagoner,  BA  •  Erin  McMullen,  BA  •  DJ  Amatuli,  BA  •  Jordan  Lee,  MA  •  Michelle  Pebole,  MA  •  Tess  Booker      

Sta*s*cian  •  Allison  Deal,  MS  

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 Physical  Ac*vity  and  Cancer  Survivorship:  A  

Workshop  for  Researchers      •  Rizzo  Center  on  Thursday,  April  14,  9am-­‐4pm  

–  Joint  endeavor  with  Duke  and  Wake  Forest  Cancer  Centers  –  Keynote  by  Kerry  Courneya,  PhD  Professor  and  Canada  Research  Chair  in  Physical  AcDvity  and  Cancer  at  the  University  of  Alberta  

–  State  of  the  Science  and  overview  of  research  experDse  across  the  three  cancer  centers  

–  Breakout  sessions  to  promote  inter-­‐insDtuDonal  collaboraDon    

–  InformaDon  on  access  to  pilot  funds  

QuesDons    

Ashley  Leak  Bryant  PhD,  RN-­‐BC,  OCN  ashley_bryant@unc.edu  

     

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