UvA-DARE (Digital Academic Repository) Physical exercise ... · Wim H. van Harten Edwin Geleijn Marianne de Maaker-Berkhof Jolanda Schrama Maud M. Geenen Jetske M. Meerum Terwogt

UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl)

UvA-DARE (Digital Academic Repository)

Physical exercise during adjuvant chemotherapy

van Waart, H.

Publication date2017Document VersionOther versionLicenseOther

Link to publication

Citation for published version (APA):van Waart, H. (2017). Physical exercise during adjuvant chemotherapy.

General rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s)and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an opencontent license (like Creative Commons).

Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, pleaselet the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the materialinaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letterto: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. Youwill be contacted as soon as possible.

Download date:14 Apr 2021

https://dare.uva.nl/personal/pure/en/publications/physical-exercise-during-adjuvant-chemotherapy(19a5230d-60bb-4629-bdcc-84d57836f55d).html

Chapter 7

Recruitment to and pilot results of the PACES randomized trial of physical exercise during adjuvant chemotherapy for colon cancer

Hanna van WaartMartijn M. Stuiver

Wim H. van HartenEdwin Geleijn

Marianne de Maaker-Berkhof Jolanda SchramaMaud M. Geenen

Jetske M. Meerum TerwogtSimone M. van den Heiligenberg

Jeannette A.J.H. Hellendoorn-van VreeswijkGabe S. Sonke

Neil K. Aaronson

Submitted

112

Chapter 7

ABSTRACT

Purpose

We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy.

Methods

Participants were randomized to a low intensity, home based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack) or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at 6-month follow-up.

Results

Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. 45% of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude towards exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up.

Conclusions

Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both a home-based and supervised program are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial.

113

Recruitment to and results of PACES for patients with colon cancer

7

INTRODUCTION

Physical exercise during chemotherapy may mitigate the side effects of cancer and its treatment.1 Although colon cancer is the third most common cancer in men and second most common cancer in women,2 research on the effect of exercise during treatment in this group is very scarce. To date, three (pilot) studies have investigated the effect of exercise during treatment for patients with colon cancer.3–5 The largest randomized controlled trial included 102 participants within three months after surgery for colorectal cancer.3 Although 65% of the patients received chemotherapy, it is unclear how many were under treatment during the exercise program. The second published study was a non-randomized study of 45 patients who, based on their preference, followed a supervised exercise program or received an information booklet. The supervised exercise program yielded larger effects on physical activity level, role functioning and pain.4 The third, randomized controlled trial included 33 patients undergoing active treatment.5 This small study showed favorable outcomes for the intervention group on physical and general fatigue and physical functioning compared to usual care. The authors reported having had significant problems with recruiting patients into the study.

Recruitment of patients with colon cancer into exercise trials is challenging.5,6 Exercise trials conducted with heterogeneous patient samples typically have included relatively few patients with colon cancer, ranging from 5% to 13%.7–13 Increased understanding of the characteristics of (non)-participants could point toward potential strategies for increasing the willingness of colon cancer patients to exercise during treatment and participate in such studies.

In this paper we report on the type of patients with colon cancer recruited into a larger, randomized controlled trial evaluating a home-based low intensity, physical activity program (Onco-Move) and a supervised moderate- to high-intensity, combined resistance and aerobic exercise program (OnTrack) during adjuvant chemotherapy for breast and colon cancer, and the outcome data of the trial for the participants with colon cancer.14

METHODS

Research design and study sample

The current study is part of the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES), a randomized, controlled, multicenter trial with two intervention groups and a Usual Care control group for patients with breast or colon cancer. Full details of the study design and interventions, and results for patients with breast cancer have been published elsewhere.14,15 The following describes the procedures for recruiting colon cancer patients into the trial.

Briefly, patients were eligible for participation in the trial when scheduled to undergo adjuvant chemotherapy in the wider Amsterdam region of the Netherlands. Patients were excluded if they had serious orthopedic, cardiovascular or cardiopulmonary conditions, were suffering from malnutrition, had serious psychiatric or cognitive problems, or did not have

114

Chapter 7

basic fluency in Dutch. There was no upper age limit. The institutional review boards of all participating hospitals approved the study.

Procedure

The treating physicians identified potentially eligible patients. Eligible patients who declined to participate in the trial were asked to briefly explain reason(s) for their decision and to complete a questionnaire assessing their health-related quality of life, exercise behavior and attitudes towards exercise.

Consenting patients were randomly assigned to Onco-Move, OnTrack or Usual Care using the minimization method16 which ensured blinding of treatment allocation, and balanced groups with respect to age, primary diagnosis and treating hospital. Trial participants underwent performance-based tests and completed questionnaires at three points in time: prior to randomization and start of chemotherapy, at completion of chemotherapy, and six months after completion of chemotherapy. Both trial participants and non-participants who filled in the questionnaire provided written informed consent.

Interventions

Onco-Move is a home-based, low intensity, individualized, self-managed physical activity program,17 with the addition of behavioral reinforcement techniques. Specially trained nurses encouraged participants to engage in at least 30 minutes of physical activity per day, five days a week, with an intensity level of 12-14 on the Borg Scale of perceived exertion.18 Participants received written information tailored to the individual’s preparedness to exercise according to the Transtheoretical model,19 and an activity diary that was discussed at each chemotherapy cycle.

OnTrack is a moderate- to high-intensity, supervised combined resistance and aerobic exercise program.20 Participants trained twice weekly under supervision of specially trained physical therapists. Six large muscle groups were trained for 20 minutes per session in two series of eight repetitions at 80% of 1-repetition maximum. This was followed by 30 minutes of aerobic exercises at an intensity of 50 to 80% of the predicted maximal workload of the steep ramp test.21 The intensity was further adjusted using the Borg Scale, with a threshold of <12 for increase and >16 for decrease of intensity.18 Participants in this group were also encouraged to be physically active five days a week for 30 minutes, and to keep an activity diary. Both interventions started with the first cycle of chemotherapy and continued until three weeks after the last cycle.

Usual Care varied according to hospital guidelines and preferences, but did not involve routine exercise.

Study measures

Reasons for non-participation

Reasons for non-participation were assessed with preset response options and an ‘other’ category. Based on reasons for non-participation, we grouped the non-participants who

115


7

completed the questionnaire into (a) those who wished to exercise by themselves; and (b) those who did not wish to exercise (in the context of a trial).22 Based on behavioral theory,23,24 we expected that factors associated significantly with the decision not to participate would be different for these two groups of decliners.

Sociodemographic and clinical characteristics

For both trial participants and non-participants who agreed to be assessed at baseline, sociodemographic data, including age, sex, education, marital status, living and work situation, lifestyle variables, and comorbidity data, were obtained via self-report. Clinical data, including tumor stage and treatment were obtained from the medical records.

Baseline questionnaire

Both the trial participants and those non-participants who were willing to do so completed a baseline questionnaire assessing fatigue (MFI),25 health-related quality of life (EORTC QLQ-C30),26 psychological distress (HADS),27 self-reported physical activity level (PASE),28 exercise behavior, and attitudes towards exercise during chemotherapy. Behavior and attitudes towards exercise during chemotherapy included questions about exercise stage,29 self-efficacy,29 social support,30 benefits,23,24 barriers,23,24 and attitudes23 towards exercise during chemotherapy. These measures are described in detail elsewhere.22

Primary outcomes over time for trial participants

Primary outcomes for the trial participants included cardiorespiratory fitness, muscle strength and fatigue. Cardiorespiratory fitness was assessed with the steep ramp test21 and an endurance test at 70% of the predicted Wmax,14 muscle strength with the MicroFET® hand held dynamometer (Hoggan Health, Salt Lake City, UT) for elbow flexion31 and knee extension32 and the Jamar grip strength dynamometer (Lafayette Instrument, Lafayette, IN),33 and lower-limb muscle endurance with the 30-s chair stand test.34 Fatigue was measured with the Multidimensional Fatigue Inventory (MFI).25

Secondary outcomes over time for trial participants

Secondary outcomes relevant to the current analysis included the variables as described above included in the baseline questionnaire (fatigue, health-related quality of life, distress, self-reported activity level, and exercise behavior and attitudes). Chemotherapy regimen and dose, adverse effects of chemotherapy and completion rates were extracted from the medical records. Compliance to the exercise programs was based on the number of attended sessions (On Track) and on the activity diary (both Onco-Move and OnTrack).

Statistical analysis

Descriptive statistics were used to characterize the study sample, and to report data regarding recruitment and reasons for non-participation in the trial. Scores on the MFI, EORTC QLQ-C30, HADS, and PASE were calculated according to published scoring algorithms.

116

Chapter 7

We report means and standard deviations (SD) for each group at each assessment point. Mean differences between trial participants and non-participants who completed the questionnaire are provided, accompanied by the 95% confidence interval and r-type effect size (ES).35 Effect sizes of 0.1 are considered small, 0.3 moderate, and 0.5 large.35 Due to the small sample size (see below), we did not carry out statistical tests of group differences in outcomes over time. Rather, we report the results descriptively (means, standard deviations, range, percentages, etc.).

Referred eligible patients (n=63)

Declined participation (n=40)Too many things on mind (n=17)Want to exercise by him/herself (n=11)Poor timing (n=8)Travel distance (n=8)Too time-consuming (n=5)Does not want to exercise (n=5)Travel distance too far (n=35)Did not want to participate in RCT (n=5)(Patients could provide more than one reason)

Randomly assigned (n=23)

Usual Care (n=8)Onco-Move (n=8)OnTrack (n=7)

Figure 1. CONSORT diagram of patients with colon cancer participating in the Physical Exercise During Adjuvant Chemotherapy Effectiveness Study (PACES).

End of chemotherapyQuestionnaire data (n=7)Physical performance data (n=7)

Only provided reason, age and gender (n=22)

Filled in the one-off questionnaire (n=18)



6-month follow-upQuestionnaire data (n=6)Physical performance data (n=6)



117


7

RESULTS

Recruitment

Between March 2010 and December 2012, 23 of 63 eligible patients with colon cancer (37%) were recruited into the study (Figure 1). Of the 40 non-participants, 18 (45%) completed the full questionnaire, while the remaining 22 patients (55%) provided only basic sociodemographic information and reasons for non-participation.

Directly after chemotherapy 21 participants (91%) completed the questionnaire and 19 (83%) underwent physical performance tests. At 6-month follow-up 21 participants (91%) completed the questionnaire and 18 (78%) underwent physical performance tests (Figure 1).

Reasons for non-participation

The self-report reasons for not participating in the trial were aggregated into seven categories. Non-participants who completed the questionnaire more often reported wanting to exercise on their own (39% versus 18%, non-participants who filled in the questionnaire versus non-participants providing only reason, respectively), travel distance (33% versus 9%) and the time it would cost them to participate (22% versus 5%) as reasons for non-participation (Table 1).

Based on reasons for non-participation, we grouped the non-participants who completed the questionnaire into (a) those who wished to exercise on their own (N=7); and (b) those who did not wish to exercise (in the context of a trial) (N=11).

Sociodemographic and clinical variables

The mean age of all eligible patients was 58 years and 57% was female (Table 2). Of the trial participants and non-participants who completed the questionnaire, respectively 70% and 89% had a partner, 48% and 28% had a college or university degree, and 35% and 50% were employed. Most had stage III colon cancer, about half underwent laparoscopic surgery, and only one in each group received radiotherapy. There were two chemotherapy regimens prescribed: (1) eight cycles of CAPOX (capecitabine and oxaliplatin) every three weeks; and

NP NPBReasons N=18 N=22

Too many things on mind 7 (39%) 10 (45%)Want to exercise by him/herself 7 (39%) 4 (18%)Poor timing 4 (22%) 4 (18%)Travel distance 6 (33%) 2 (9%)Too time consuming 4 (22%) 1 (5%)Does not want to exercise 2 (11%) 3 (14%)Does not want to participate in RCT 2 (11%) 3 (14%)

Table 1. Self-reported reasons for non-participation in the PACES trial (N=40)

Patients could provide multiple reasons for non-participation. Abbreviations: NP, non-participants who provided both reasonsfor non-participation and completed the questionnaire; NPB, non-participants who provided only basic sociodemographicinformation and reasons for non-participation; RCT, randomized control trial.

118

Chapter 7

Tabl

e 2.

Bas

elin

e so

ciod

emog

raph

ic a

nd c

linic

al c

hara

cter

isti

cs

TP

NP-

EN

P-O

NPB

OnT

rack

Onc

o-M

ove

Usu

al C

are

N=2

3N

=7N

=11

N=2

2N

=7N

=8N

=8

Age

mea

n ye

ars (

SD)

58.2

(10.

1)55

.4 (9

.2)

61.7

(6.6

)57

.8 (1

3.7)

57.7

(13.

2)60

.1 (7

.3)

56.7

(10.

6)G

ende

r N fe

mal

e (%

)14

(61%

)3

(43%

)8

(73%

)11

(50%

)5

(71%

)3

(38%

)6

(75%

)BM

I mea

n (S

D)

24.0

(3.1

)23

.5 (4

.1)

24.1

(3.7

)25

.1 (4

.2)

23.6

(2.1

)23

.5 (3

.1)

Mar

ital

sta

tus

N (%

)Si

ngle

/div

orce

d/w

idow

ed7

(30%

)0

(0%

)2

(18%

)2

(29%

)2

(25%

)3

(38%

)M

arrie

d/liv

ing

toge

ther

16 (7

0%)

7 (1

00%

)9

(82%

)5

(71%

)6

(75%

)5

(63%

)Ed

ucat

ion

N (%

)Pr

imar

y/m

iddl

e sc

hool

9 (3

9%)

4 (5

7%)

4 (3

6%)

2 (2

9%)

5 (6

3%)

2 (2

5%)

Hig

h sc

hool

3 (1

3%)

1 (1

4%)

4 (3

6%)

1 (1

4%)

0 (0

%)

2 (2

5%)

Colle

ge/u

nive

rsity

11 (4

8%)

2 (2

9%)

3 (2

7%)

4 (5

7%)

3 (3

8%)

4 (5

0%)

Wor

k N

(%)

Full-

time

or p

art-

time

8 (3

5%)

4 (5

7%)

5 (4

5%)

3 (4

3%)

2 (2

5%)

3 (3

8%)

Oth

er*

15 (6

5%)

3 (4

3%)

6 (5

5%)

4 (5

7%)

6 (7

5%)

5 (6

3%)

Canc

er s

tage

N (%

)St

age

II3

(13%

)2

(29%

)2

(18%

)1

(14%

)1

(13%

)1

(13%

)St

age

III18

(78%

)4

(57%

)7

(64%

)6

(86%

)6

(75%

)6

(75%

)St

age

IV2

(9%

)1

(14%

)1

(9%

)0

(0%

)1

(13%

)1

(13%

)Ca

ncer

trea

tmen

t N (%

)La

paro

scop

ic s

urge

ry12

(52%

)2

(29%

)7

(64%

)4

(57%

)6

(75%

)2

(25%

)Ra

diot

hera

py1

(4%

)0

(0%

)1

(9%

)0

(0%

)0

(0%

)1

(13%

)Pr

escr

ibed

che

mot

hera

py N

(%)

CAPO

X19

(83%

)3

(43%

)8

(73%

)5

(71%

)8

(100

%)

6 (7

5%)

FOLF

OX

4 (1

7%)

4 (5

7%)

2 (1

8%)

2 (2

9%)

0 (0

%)

2 (2

5%)

Com

orbi

dity

N (%

)15

(65%

)5

(71%

)7

(64%

)2

(29%

)7

(88%

)6

(75%

)Cu

rren

t sm

oker

N (%

)1

(4%

)0

(0%

)2

(18%

)0

(0%

)0

(0%

)1

(13%

)

Abb

revi

atio

ns:S

D,s

tand

ard

devi

atio

n;TP

,tria

lpar

ticip

ants

;NP-

E,no

n-pa

rtic

ipan

tsw

hoco

mpl

eted

the

ques

tionn

aire

,who

wan

ted

toex

erci

seby

them

selv

es;N

P-O

,non

-par

ticip

ants

who

com

plet

edth

equ

estio

nnai

re,w

hoca

nnot

ordo

notw

antt

oex

erci

se;N

PB,n

on-p

artic

ipan

tsw

hopr

ovid

edba

sic

soci

odem

ogra

phic

info

rmat

ion

and

reas

ons

forn

on-p

artic

ipat

ion.

*Stu

dent

s,ho

me-

mak

ers,

retir

ed, a

nd u

nem

ploy

ed.

Char

acte

ristic

119


7

Tabl

e 2.

Bas

elin

e so

ciod

emog

raph

ic a

nd c

linic

al c

hara

cter

isti

cs

TP

NP-

EN

P-O

NPB

OnT

rack

Onc

o-M

ove

Usu

al C

are

N=2

3N

=7N

=11

N=2

2N

=7N

=8N

=8

Age

mea

n ye

ars (

SD)

58.2

(10.

1)55

.4 (9

.2)

61.7

(6.6

)57

.8 (1

3.7)

57.7

(13.

2)60

.1 (7

.3)

56.7

(10.

6)G

ende

r N fe

mal

e (%

)14

(61%

)3

(43%

)8

(73%

)11

(50%

)5

(71%

)3

(38%

)6

(75%

)BM

I mea

n (S

D)

24.0

(3.1

)23

.5 (4

.1)

24.1

(3.7

)25

.1 (4

.2)

23.6

(2.1

)23

.5 (3

.1)

Mar

ital

sta

tus

N (%

)Si

ngle

/div

orce

d/w

idow

ed7

(30%

)0

(0%

)2

(18%

)2

(29%

)2

(25%

)3

(38%

)M

arrie

d/liv

ing

toge

ther

16 (7

0%)

7 (1

00%

)9

(82%

)5

(71%

)6

(75%

)5

(63%

)Ed

ucat

ion

N (%

)Pr

imar

y/m

iddl

e sc

hool

9 (3

9%)

4 (5

7%)

4 (3

6%)

2 (2

9%)

5 (6

3%)

2 (2

5%)

Hig

h sc

hool

3 (1

3%)

1 (1

4%)

4 (3

6%)

1 (1

4%)

0 (0

%)

2 (2

5%)

Colle

ge/u

nive

rsity

11 (4

8%)

2 (2

9%)

3 (2

7%)

4 (5

7%)

3 (3

8%)

4 (5

0%)

Wor

k N

(%)

Full-

time

or p

art-

time

8 (3

5%)

4 (5

7%)

5 (4

5%)

3 (4

3%)

2 (2

5%)

3 (3

8%)

Oth

er*

15 (6

5%)

3 (4

3%)

6 (5

5%)

4 (5

7%)

6 (7

5%)

5 (6

3%)

Canc

er s

tage

N (%

)St

age

II3

(13%

)2

(29%

)2

(18%

)1

(14%

)1

(13%

)1

(13%

)St

age

III18

(78%

)4

(57%

)7

(64%

)6

(86%

)6

(75%

)6

(75%

)St

age

IV2

(9%

)1

(14%

)1

(9%

)0

(0%

)1

(13%

)1

(13%

)Ca

ncer

trea

tmen

t N (%

)La

paro

scop

ic s

urge

ry12

(52%

)2

(29%

)7

(64%

)4

(57%

)6

(75%

)2

(25%

)Ra

diot

hera

py1

(4%

)0

(0%

)1

(9%

)0

(0%

)0

(0%

)1

(13%

)Pr

escr

ibed

che

mot

hera

py N

(%)

CAPO

X19

(83%

)3

(43%

)8

(73%

)5

(71%

)8

(100

%)

6 (7

5%)

FOLF

OX

4 (1

7%)

4 (5

7%)

2 (1

8%)

2 (2

9%)

0 (0

%)

2 (2

5%)

Com

orbi

dity

N (%

)15

(65%

)5

(71%

)7

(64%

)2

(29%

)7

(88%

)6

(75%

)Cu

rren

t sm

oker

N (%

)1

(4%

)0

(0%

)2

(18%

)0

(0%

)0

(0%

)1

(13%

)

Abb

revi

atio

ns:S

D,s

tand

ard

devi

atio

n;TP

,tria

lpar

ticip

ants

;NP-

E,no

n-pa

rtic

ipan

tsw

hoco

mpl

eted

the

ques

tionn

aire

,who

wan

ted

toex

erci

seby

them

selv

es;N

P-O

,non

-par

ticip

ants

who

com

plet

edth

equ

estio

nnai

re,w

hoca

nnot

ordo

notw

antt

oex

erci

se;N

PB,n

on-p

artic

ipan

tsw

hopr

ovid

edba

sic

soci

odem

ogra

phic

info

rmat

ion

and

reas

ons

forn

on-p

artic

ipat

ion.

*Stu

dent

s,ho

me-

mak

ers,

retir

ed, a

nd u

nem

ploy

ed.

Char

acte

ristic

TP (N

=23)

NP-

E (N

=7)

NP-

O (N

=11)

Mea

n (S

D)

Mea

n (S

D)

Mea

n (S

D)

Mea

n di

ffere

nce

(95%

CI)

ES*

Mea

n di

ffere

nce

(95%

CI)

ES*

Gen

eral

Fat

igue

a10

.1 (4

.3)

9.4

(6.1

)12

.6 (6

.2)

0.7

(-3.8

; 5.

2)0.

14-2

.4 (-

6.2

; 1.4

)0.

46

Phys

ical

Fat

igue

a12

.2 (4

.1)

8.4

(5.9

)13

.1 (5

.2)

0.8

(-3.2

; 4.

8)0.

16-2

.1 (-

5.5

; 1.3

)0.

45

Redu

ced

Act

ivity

a10

.7 (4

.0)

9.9

(5.5

)12

.7 (5

.2)

3.7

(-0.4

; 7.

9)0.

79-0

.9 (-

4.4

; 2.6

)0.

20

Redu

ced

Mot

ivat

iona

10.2

(3.8

)6.

9 (2

.9)

8.8

(2.8

)3.

3 (0

.3 ;

6.3)

0.98

1.4

(-1.2

; 3.

9)0.

41

Men

tal F

atig

uea

9.8

(4.8

)10

.0 (4

.0)

8.6

(5.2

)-0

.2 (-

4.4

; 4.0

)0.

051.

1 (-2

.4 ;

4.7)

0.23

Hea

lth-r

elat

ed q

ualit

y of

life

b69

.9 (2

1.3)

76.2

(21.

2)61

.4 (2

3.1)

-6.3

(-25

.3 ;

12.7

)0.

298.

6 (-7

.6 ;

24.7

)0.

39

Psyc

holo

gica

l dis

tres

sc9.

3 (6

.9)

7.9

(5.3

)9.

2 (5

.9)

1.4

(-4.2

; 7.

0)0.

230.

1 (-4

.7 ;

4.8)

0.01

Self-

repo

rted

act

ivity

leve

ld71

.5 (5

5.4)

61.3

(32.

7)64

.4 (4

6.2)

10.2

(-36

.7 ;

57.1

)0.

237.

1 (-3

0.4

; 44.

6)0.

14Ex

erci

se s

tage

N(%

)Pr

e-co

ntem

plat

ion

0 (0

.0%

)0

(0.0

%)

0 (0

.0%

)Co

ntem

plat

ion

8 (3

4.8%

)1

(14.

3%)

7 (6

3.6%

)Pr

epar

atio

n8

(34.

8%)

0 (0

.0%

)1

(9.1

%)

Act

ion

0 (0

.0%

)1

(14.

3%)

0 (0

.0%

)M

aint

enan

ce7

(30.

4%)

5 (7

1.4%

)3

(27.

3%)

Self-

effic

acy

6.7

(1.9

)8.

4 (1

.4)

5.7

(1.3

)-1

.7 (-

3.2

; -0.

3)1.

070.

9 (-0

.3 ;

2.2)

0.58

Soci

al s

uppo

rt4.

4 (0

.6)

4.6

(0.4

)4.

0 (1

.2)

-0.2

(-0.

9 ; 0

.5)

0.42

0.4

(-0.2

; 0.

9)0.

41Be

nefit

s3.

8 (0

.6)

4.3

(0.5

)3.

7 (0

.6)

-0.5

(-1.

0 ; 0

.1)

0.86

0.1

(-0.3

; 0.

6)0.

18Ba

rrie

rs1.

9 (0

.5)

1.4

(0.3

)1.

9 (0

.6)

0.5

(0.0

; 1.

0)1.

130.

0 (-0

.4 ;

0.4)

0.02

Att

itude

5.7

(1.2

)6.

4 (0

.8)

4.7

(1.1

)-0

.7 (-

1.7

; 0.3

)0.

711.

0 (0

.2 ;

1.8)

0.85

Tabl

e 3.

Des

crip

tive

sta

tist

ics

of fa

tigu

e, q

ualit

y of

life

and

beh

avio

ral a

nd a

ttit

udin

al fa

ctor

s fo

r tri

al p

arti

cipa

nts

and

non-

part

icip

ants

Abb

revi

atio

ns:S

D,s

tand

ard

devi

atio

n;TP

,tria

lpar

ticip

ants

;NP-

E,no

n-pa

rtic

ipan

tsw

hoco

mpl

eted

the

ques

tionn

aire

,who

wan

tto

exer

cise

byth

emse

lves

;NP-

O,n

on-

part

icip

ants

who

com

plet

edth

equ

estio

nnai

re,w

hoca

nnot

ordo

notw

antt

oex

erci

se.*

ES,r

-typ

eef

fect

size

.a MFI

,Mul

tidem

ensi

onal

Fatig

ueIn

vent

ory

(sco

rera

nge

from

4to

20,h

igh

scor

esin

dica

ting

mor

e

fatig

ue).

b EORT

CCQ

L-C3

0(s

core

rang

efr

om0

to10

0,hi

gher

scor

esin

dica

ting

bett

ergl

obal

heal

thst

atus

).c H

AD

S,H

ospi

talA

nxie

tyan

dD

epre

ssio

nSc

ale

(sco

rera

nge

from

0to

42,h

ighe

r

scor

e re

pres

ents

hig

her l

evel

s of

psy

chol

ogic

al d

istr

ess)

. d PASE

: Phy

sica

l Act

ivity

Sca

le fo

r the

Eld

erly

(tot

al a

ctiv

ity s

core

).

TP a

nd N

P-E

TP a

nd N

P-O

Mea

sure

120

Chapter 7

(2) twelve cycles of FOLFOX (folinic acid, fluorouracil and oxaliplatin) every two weeks, both resulting in a prescribed chemotherapy length of 24 weeks (Table 2).

Some sociodemographic and clinical characteristics were not equally distributed among the study groups. Participants in Onco-Move were more frequently male, had lower education, and more often received laparoscopic surgery, while participants in OnTrack had less co-morbidity.

Trial participants and non-participants

Non-participants who wanted to exercise on their own tended to be less fatigued than the trial participants. They were also more likely to be in the maintenance phase of physical activity, to report higher levels of self-efficacy, and to report more perceived benefits of exercising and fewer barriers (Table 3).

Compared with trial participants, non-participants who did not wish to exercise reported slightly more fatigue, had lower levels of self-efficacy, and a more negative attitude towards exercising during chemotherapy. Both non-participant groups reported being slightly less active than the trial participants (Table 3).

Program adherence of trial participants

On average, participants in OnTrack attended 61% of the planned sessions. Based on the exercise diary, 71% of the OnTrack group and 100% of the Onco-Move group followed the recommendations regarding daily activity levels at least 75% of the time. Three participants in the Usual Care group reported having followed an exercise program with a physical therapist.

Cardiorespiratory fitness, muscle strength

At baseline, participants in Onco-Move tended to have higher physical fitness levels than those in OnTrack or Usual Care (see Figure 2). At the end of chemotherapy, participants in OnTrack and Onco-Move had improved in endurance capacity, on average 6 and 5 minutes, respectively (Table 4 and Figure 2b). After 6-month follow-up, all groups increased their endurance capacity. The average decline in endurance capacity for participants in OnTrack, reflects the drop-out of two participants, rather than a decline in endurance capacity of the remaining participants.

Overall, all participants were able to maintain or increase their strength over time, with the exception of the lower extremity strength of OnTrack participants, who appear to have declined at the end of chemotherapy, before recovering at 6-month follow-up. Participants in Usual Care showed an increase in upper and lower extremity strength at the end of chemotherapy (Table 4 and Figure 2c and 2d).

121


7

Measure Mean (SD) [range] Mean (SD) [range] Mean (SD) [range]

OnTrack 216.1 (32.7) [167 - 252] 238.3 (33.5) [182 - 280] 240.8 (31.8) [195 - 272] Onco-Move 267.9 (65.1) [165 - 337] 258.3 (122.3) [215 - 345] 317.0 (33.9) [260 - 357] Usual Care 239.0 (56.9) [172 - 357] 243.8 (77.9) [142 - 352] 259.8 (53.2) [187 - 332]Endurance time (min) OnTrack 7.7 (3.7) [4.0 - 15.0] 14.1 (8.2) [3.3 - 25.9] 11.9 (8.6) [3.6 - 25.0] Onco-Move 15.1 (10.2) [4.9 - 30.0] 20.2 (12.4) [5.0 - 30.0] 24.5 (6.1) [17.0 - 30.0] Usual Care 7.7 (3.9) [2.2 - 15.0] 7.3 (3.9) [1.8 - 12.1] 14.2 (10.4) [2.8 - 30.0]HDD elbow flexion (Nm) OnTrack 36.0 (13.9) [19 - 55] 35.6 (18.2) [16 - 62] 43.3 (13.2) [30 - 62] Onco-Move 49.2 (20.0) [18 - 86] 53.0 (22.9) [19 - 94] 63.0 (15.7) [41 - 85] Usual Care 38.3 (19.8) [17 - 81] 50.0 (21.3) [28 - 85] 49.7 (30.1) [22 - 89]HDD knee extension (Nm) OnTrack 73.5 (24.7) [48 - 108] 64.0 (16.5) [41 - 89] 76.3 (16.1) [61 - 99] Onco-Move 76.3 (25.3) [47 - 118] 77.7 (25.6) [45 - 110] 89.1 (20.2) [58 - 119] Usual Care 79.3 (39.5) [42 - 155] 90.1 (30.6) [55 - 129] 82.4 (45.0) [41 - 149]Gripstrength (kg) OnTrack 30.6 (12.6) [20 - 56] 33.6 (11.9) [22 - 56] 31.4 (14.4) [18 - 54] Onco-Move 35.0 (8.8) [21 - 52] 38.2 (8.4) [29 - 50] 41.2 (5.8) [35 - 52] Usual Care 33.1 (13.3) [18 - 63] 38.5 (17.8) [26 - 73] 36.8 (14.6) [26 - 63]30-s chair stand (times) OnTrack 14.6 (3.7) [10 - 19] 15.6 (5.2) [10 - 23] 19.0 (6.9) [9 - 26] Onco-Move 14.8 (5.4) [7 - 23] 18.9 (7.9) [9 - 31] 19.2 (6.8) [11 - 27] Usual Care 14.4 (3.5) [11 - 21] 15.5 (3.5) [13 - 22] 16.7 (3.5) [13 - 23]

Table 4. Mean values of physical fitness

Abbreviations: T0, Baseline prior to chemotherapy; T1, at completion of chemotherapy; T2, six months after completion ofchemotherapy; SD, Standard deviation

T0 (N=23) T1 (N=19) T2 (N=18)

Maximal short exercise capacity (Watts)

Fatigue

There was no clear trend over time or within the groups in experienced fatigue (MFI, Table 5 and Figure 3), although, on average, all participants reported less fatigue at 6-month follow-up, compared to baseline.

122

Chapter 7

Figure 2. Change in physical fitness of the individual participants at baseline (T0), end of chemotherapy (T1) and 6-month follow-up (T2). (2a) Maximal short exercise capacity (Watts); (2b) Endurance time (minutes); (2c) hand held dynamometer of elbow flexion (Nm); (2d) hand held dynamometer of knee extension (Nm).

0

5

10

15

20

25

30

T0 T1 T2 T0 T1 T2 T0 T1 T2

OnTrack Onco-Move Usual Care

0

20

40

60

80

100

120

140

160

T0 T1 T2 T0 T1 T2 T0 T1 T2


0

20

40

60

80

100

120

140

160

T0 T1 T2 T0 T1 T2 T0 T1 T2


0

50

100

150

200

250

300

350

400

T0 T1 T2 T0 T1 T2 T0 T1 T2


2b

2c

2d

2a

Max

imal

sho

rt e

xerc

ise

capa

city

(Wat

ts)

Endu

ranc

e tim

e (m

inut

es)

Han

d he

ld d

ynam

omet

er o

f elb

ow fl

exio

n (N

m)

Han

d he

ld d

ynam

omet

er o

f kne

e ex

tens

ion

(Nm

)

123


7

MFI measure Mean (SD) [range] Mean (SD) [range] Mean (SD) [range]

Physical fatigue OnTrack 12.1 (3.9) [7 - 18] 12.0 (3.7) [6 - 18] 8.0 (3.0) [5 - 13] Onco-Move 9.4 (4.0) [4 - 13] 7.4 (3.6) [4 - 14] 8.4 (4.2) [4 - 16] Usual Care 10.6 (4.1) [4 - 15] 14.8 (9.4) [4 - 17] 8.4 (4.8) [4 - 16]General fatigue OnTrack 10.7 (3.7) [4 - 15] 12.4 (4.5) [6 - 18] 7.7 (3.3) [5 - 14] Onco-Move 10.1 (4.9) [4 - 19] 8.0 (3.7) [4 - 15] 9.1 (4.8) [4 - 15] Usual Care 9.6 (4.6) [4 - 15] 11.6 (3.6) [8 - 18] 8.9 (4.9) [4 - 16]Reduced activity OnTrack 13.1 (3.5) [8 - 19] 13.7 (3.4) [9 - 20] 9.0 (2.8) [5 - 13] Onco-Move 11.1 (4.8) [4 - 18] 7.9 (2.0) [6 - 11] 8.7 (5.0) [4 - 17] Usual Care 12.4 (4.2) [5 - 16] 10.6 (3.6) [4 - 14] 9.1 (4.8) [4 - 16]Reduced motivation OnTrack 11.1 (4.6) [4 - 16] 10.3 (4.4) [5 - 19] 7.5 (3.3) [4 - 12] Onco-Move 9.6 (3.6) [5 - 13] 7.0 (2.3) [4 - 11] 6.3 (3.1) [4 - 11] Usual Care 9.9 (3.8) [6 - 17] 8.1 (3.0) [4 - 12] 8.0 (3.5) [4 - 15]Mental fatigue OnTrack 9.4 (5.0) [4 - 17] 10.7 (5.5) [4 - 18] 6.3 (2.4) [4 - 10] Onco-Move 10.4 (5.2) [4 - 20] 7.9 (3.1) [4 - 12] 6.6 (3.3) [4 - 13] Usual Care 9.5 (4.9) [4 - 20] 10.7 (2.1) [8 - 13] 7.9 (3.4) [4 - 14]

Table 5. Mean values of fatigue

T0 (N=23) T1 (N=21) T2 (N=21)

Abbreviations: T0, Baseline prior to chemotherapy; T1, at completion of chemotherapy; T2, six months after completion ofchemotherapy; SD, Standard deviation; MFI, Multidemensional Fatigue Inventory (score range from 4 to 20, high scoresindicating more fatigue).

0

2

4

6

8

10

12

14

16

18

20

T0 T1 T2 T0 T1 T2 T0 T1 T2


3a

Figure 3. Change in Multidimensional Fatigue Inventory (MFI) scores of the individual participants at baseline (T0), end of chemotherapy (T1) and 6-month follow-up (T2). (3a) general fatigue; (3b) physical fatigue.

0

2

4

6

8

10

12

14

16

18

20

T0 T1 T2 T0 T1 T2 T0 T1 T2


3b

MFI

sco

re -

phys

ical

fatig

ueM

FI s

core

- ge

nera

l fat

igue

124

Chapter 7

Physical activity and health-related quality of life

Self-reported physical activity levels, global health status and physical functioning (both measures of health-related quality of life) improved over time in all groups, while psychological distress decreased over time, albeit at different rates (Table 6). We would again note that the baseline values were slightly better for the participants in Onco-Move. No other clear trends were observed for the remaining health-related quality of life variables assessed by the QLQ-C30.

Chemotherapy completion rates

The planned chemotherapy regimens and schedules of the three groups were very similar, with a total planned duration of 168 days (Table 2). Participants in OnTrack received, on average, 87% (SD 15%), in Onco-Move, 92% (SD 8%), and in Usual Care, 78% (SD 16%) of the planned dose.

DISCUSSION

In this paper we have described the recruitment of participants with colon cancer into the PACES trial, provided insight into the non-participants, and reported descriptively the outcomes for the trial participants.

The participation rate of 37% of the referred patients is quite similar to previous exercise-oncology trials.5,22,36 This was a somewhat lower percentage participation rate than for the


Self Reported Activity Levela

OnTrack 71.7 (75.2) [5.0 - 189.9] 100.9 (80.5) [5.5 - 235.0] 113.4 (48.1) [28.1 - 159.3] Onco-Move 70.4 (44.3) [20.5 - 154.8] 98.3 (51.1) [36.5 - 162.1] 97.7 (38.0) [62.3 - 168.9] Usual Care 72.3 (53.4) [8.6 - 153.2] 88.7 (35.5) [54.4 - 140.9] 120.6 (46.0) [66.1 - 188.9]

Global health statusb


Physical functioningb


Psychological distressc


T2 (N=21)

Abbreviations: T0, Baseline prior to chemotherapy; T1, at completion of chemotherapy; T2, six months after completion of

chemotherapy; SD, Standard deviation. aPASE: Physical Activity Scale for the Elderly (total activity score). bEORTC CQL-C30

(score range from 0 to 100, higher scores indicating better global health status). cHADS: Hospital Anxiety and Depression Scale

(score range from 0 to 42, higher score represents higher levels of psychological distress). c

Table 6. Mean values of secondary outcome measures

T0 (N=23) T1 (N=21)

125


7


Self Reported Activity Levela


Global health statusb


Physical functioningb


Psychological distressc


T2 (N=21)

Abbreviations: T0, Baseline prior to chemotherapy; T1, at completion of chemotherapy; T2, six months after completion of

chemotherapy; SD, Standard deviation. aPASE: Physical Activity Scale for the Elderly (total activity score). bEORTC CQL-C30

(score range from 0 to 100, higher scores indicating better global health status). cHADS: Hospital Anxiety and Depression Scale

(score range from 0 to 42, higher score represents higher levels of psychological distress). c

Table 6. Mean values of secondary outcome measures

T0 (N=23) T1 (N=21)

breast cancer patients in this trial (44%).15 However, the absolute number of colon cancer participants recruited was much lower than anticipated. There were several reasons for this. First, more patients than anticipated were receiving palliative rather than adjuvant chemotherapy, resulting in a much smaller pool of potential patients. Second, clinicians seemed hesitant to refer patients with colon cancer to our study. Recently Courneya et al.6 described this phenomenon where staff labeled patients as “not look like an exerciser”, as “too old” or as “unable to exercise”. This could also reflect the fact that colon cancer patients often have more significant postsurgical complaints (e.g., prolonged wound healing, stomas and bowel problems) than do patients with breast cancer.13 In any case, this suggests the need to explain more clearly to both clinicians and patients that the physical exercise program will be tailored to the functional status and capacity of each individual patient. Lastly, because of differences in the way in which the adjuvant treatment care planning was organized for the colon versus breast cancer patients, it was more difficult to screen colon cancer patients for potential eligibility and to inform the treating physician about eligible patients in a timely manner.

About one-third of the colon cancer non-participants reported that they wished to exercise on their own. This subgroup of non-participants may be of less concern, as they may be able to maintain their physical fitness levels throughout their chemotherapy without formal intervention.37 However, this needs to be assessed empirically. The remaining two-thirds of the non-participants, those who did not wish to exercise (in the context of a trial), reported slightly more fatigue, lower levels of self-efficacy, and a more negative attitude towards exercise during chemotherapy. The overall trend seems to be quite similar to the group of non-participants with breast cancer.22 Future research is needed to better understand how these patients with attitudes and beliefs that are not conducive to exercising can nevertheless be motivated to increase their physical activity levels. We would note that uptake of physical exercise in this subgroup of patients may be higher in daily clinical practice than in a research setting where there are trial-specific requirements (questionnaires and performance-based testing).38

On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up. Although these results need to be interpreted with a good deal of caution due to the small numbers (and thus the inability to test differences statistically), they are in line with previous research with patients with colon cancer during chemotherapy,3,5 although more so for the results pertaining to the participants in Onco-Move and Usual Care than those in OnTrack.

In small study groups, individual effects, even when relatively small, can influence average effects. This appeared to be the case in the current analysis, where the results were probably influenced by drop-outs and the fact that several control group members pursued active physical training. Thus, the observed decline in endurance capacity at 6-month follow-up for participants in OnTrack may reflect the fact that follow-up data were missing for two of the patients in this group who had higher endurance capacity than the average of this group at earlier assessment points. A larger trial with significantly more participants per group would

126

Chapter 7

be much less sensitive to such individual variations and influences.

As commonly reported in exercise oncology trials, those randomized to the Usual Care were not necessarily sedentary.39 Despite the request not to follow a formal exercise program, three of the participants in the Usual Care group received an exercise program supervised by a physical therapist, similar to OnTrack; in at least one case, exactly the same as OnTrack. Interestingly, the muscle strength of these three patients increased more than those in the OnTrack group. This could be a chance finding, but may also reflect a higher degree of motivation of patients who seek out exercise training opportunities despite their assignment to a control group.

To the best of our knowledge, this is the first study to include a home-based exercise program during chemotherapy for patients with colon cancer. The adherence rate of 100%, which we defined as being physically active for at least 30 minutes on at least 75% of the prescribed days in Onco-Move was uncommonly high.37 Although these results are based on self-report, our results suggest that patients benefited from following the Onco-Move program, and certainly that such a home-based program is feasible and safe for the patients with colon cancer.

Patients in both the OnTrack (87%) and Onco-Move (92%) group received more of the planned chemotherapy than those in Usual Care (78%). This is in line with previous reports for patients with breast cancer following an exercise program during chemotherapy.5,15,40 Future research is needed to determine if the positive effect of exercise on chemotherapy completion rates translates into improved clinical outcomes (disease-free and overall survival).

The main limitations of the current study were the small sample size and the apparent contamination of the Usual Care group. Our study also had a number of notable strengths, including extensive data on reasons for non-participation and detailed information on sociodemographic, clinical, attitudinal, and behavioral factors potentially associated with non-participation, the randomized controlled design, the inclusion of a home-based exercise program and the high adherence rates in both exercise groups.

In conclusion, our results emphasize the need for improved recruitment strategies for recruiting patients with colon cancer undergoing chemotherapy into (clinical trials assessing) physical activity and exercise programs. Important in this regard is the need to better inform both patients and their formal and informal caregivers that exercise is safe and feasible, can be tailored to individual needs and levels of functioning, and can be performed at home without supervision or in a supervised setting. At the same time, larger scale trials are still needed to establish the efficacy of such interventions in this patient population.

127


7

REFERENCES1. Furmaniak AC, Menig M, Markes MH. Exercise for women receiving adjuvant therapy for breast cancer. In:

Furmaniak AC (ed.). Cochrane Database of Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd; 2016.

2. Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer, 2015; 136: E359–86.

3. Courneya KS, Friedenreich CM, Quinney H a, et al. A randomized trial of exercise and quality of life in colorectal cancer survivors. Eur J Cancer Care, 2003; 12: 347–57.

4. Lin K, Shun S, Lai Y, et al. Comparison of the effects of a supervised exercise program and usual care in patients with colorectal cancer undergoing chemotherapy. Cancer Nurs, 2014; 37: E21-9.

5. van Vulpen JK, Velthuis MJ, Bisschop CNS, et al. Effects of an exercise program in colon cancer patients undergoing chemotherapy. Med Sci Sports Exerc, 2016; 48: 767–75.

6. Courneya KS, Vardy J, Gill S, et al. Update on the colon health and life-long exercise change trial: A phase III study of the impact of an exercise program on disease-free survival in colon cancer survivors. Curr Colorectal Cancer Rep, 2014; 10: 321–8.

7. Adamsen L, Quist M, Andersen C, et al. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: Randomised controlled trial. BMJ, 2009; 339: b3410.

8. Schwartz AL, Winters-Stone K. Effects of a 12-month randomized controlled trial of aerobic or resistance exercise during and following cancer treatment in women. Phys Sportsmed, 2009; 37: 62–7.

9. Griffith K, Wenzel J, Shang J, et al. Impact of a walking intervention on cardiorespiratory fitness, self-reported physical function, and pain in patients undergoing treatment for solid tumors. Cancer, 2009; 115: 4874–84.

10. Courneya KS, Jones LW, Peddle CJ, et al. Effects of aerobic exercise training in anemic cancer patients receiving darbepoetin alfa: A randomized controlled trial. Oncologist, 2008; 13: 1012–20.

11. Schneider CM, Hsieh CC, Sprod LK, et al. Exercise training manages cardiopulmonary function and fatigue during and following cancer treatment in male cancer survivors. Integr Cancer Ther, 2007; 6: 235–41.

12. van Rooijen SJ, Engelen MA, Scheede-Bergdahl C, et al. Systematic review of exercise training in colorectal cancer patients during treatment. Scand J Med Sci Sports, 2017; 1–11.

13. Moller T, Lillelund C, Andersen C, et al. The challenge of preserving cardiorespiratory fitness in physically inactive patients with colon or breast cancer during adjuvant chemotherapy: A randomised feasibility study. BMJ Open Sport Exerc Med, 2015; 1: e000021.

14. van Waart H, Stuiver MM, van Harten WH, et al. Design of the physical exercise during adjuvant chemotherapy effectiveness study (PACES): A randomized controlled trial to evaluate effectiveness and cost-effectiveness of physical exercise in improving physical fitness and reducing fatigue. BMC Cancer, 2010; 10: 673.

15. van Waart H, Stuiver MM, van Harten WH, et al. Effect of low-intensity physical activity and moderate- to high-intensity physical exercise during adjuvant chemotherapy on physical fitness, fatigue, and chemotherapy completion rates: Results of the PACES randomized clinical trial. J Clin Oncol, 2015; 33: 1918–27.

16. Scott NW, McPherson GC, Ramsay CR, et al. The method of minimization for allocation to clinical trials: A review. Control Clin Trials, 2002; 23: 662–74.

17. Mock V, Cameron L, Tompkins C, et al. Every step counts: A walking exercise program for persons with cancer. Baltimore: The John Hopkins University; 2008.

18. Borg G. Borg’s percieved exertion and pain scales. 1998th ed. Champaign, IL: Human Kinetic; 2010.

19. van der Ploeg HP, Streppel KRM, van der Beek AJ, et al. Counselling increases physical activity behaviour nine weeks after rehabilitation. Br J Sports Med, 2006; 40: 223–9.

20. Geleijn E, Smeets C, Vrijman M, et al. CytoFys, behoud van kracht en uithoudingsvermogen tijdens chemotherapie. Ned Tijdschr voor Oncol, 2011; 8: 80–6.

128

Chapter 7

21. de Backer IC, Schep G, Hoogeveen A, et al. Exercise testing and training in a cancer rehabilitation program: The advantage of the steep ramp test. Arch Phys Med Rehabil, 2007; 88: 610–6.

22. van Waart H, van Harten WH, Buffart LM, et al. Why do patients choose (not) to participate in an exercise trial during adjuvant chemotherapy for breast cancer? Psycho-oncology, 2016; 25: 964–70.

23. Courneya KS, Friedenreich CM. Utility of the theory of planned behavior for understanding exercise during breast cancer treatment. Psycho-oncology, 1999; 8: 112–22.

24. van der Ploeg HP, van der Beek AJ, van der Woude LH V, et al. Physical activity for people with a disability: A conceptual model. Sports Med, 2004; 34: 639–49.

25. Smets EM, Garssen B, Bonke B, et al. The multidimensional fatigue inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res, 1995; 39: 315–25.

26. Aaronson NK, Ahmedzai S, Bergman B, et al. The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst, 1993; 85: 365–76.

27. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand, 1983; 67: 361–70.

28. Washburn R, McAuley E, Katula J, et al. The physical activity scale for the elderly (PASE): evidence for validity. J Clin Epidemiol, 1999; 52: 643–51.

29. Marcus BH, Selby VC, Niaura RS, et al. Self-efficacy and the stages of exercise behavior change. Res Q Exerc Sport, 1992; 63: 60–6.

30. Sallis JF, Calfas KJ, Alcaraz JE, et al. Potential mediators of change in a physical activity promotion course for university students: Project GRAD. Ann Behav Med, 1999; 21: 149–58.

31. van der Ploeg RJ, Fidler V, Oosterhuis HJ. Hand-held myometry: Reference values. J Neurol Neurosurg Psychiatry, 1991; 54: 244–7.

32. Knols RH, Aufdemkampe G, de Bruin ED, et al. Hand-held dynamometry in patients with haematological malignancies: Measurement error in the clinical assessment of knee extension strength. BMC Musculoskelet Disord, 2009; 10: 31.

33. Trutschnigg B, Kilgour RD, Reinglas J, et al. Precision and reliability of strength (Jamar vs. Biodex handgrip) and body composition (dual-energy X-ray absorptiometry vs. bioimpedance analysis) measurements in advanced cancer patients. Appl Physiol Nutr Metab, 2008; 33: 1232–9.

34. Jones C, Rikli R, Beam W. A 30-s chair-stand test as a measure of lower body strength in communicity-residing older adults. Res Q Exerc Sport, 1999; 70.

35. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale NJ: Lawrence Erlbaum; 1988.

36. Sears SR, Stanton AL, Kwan L, et al. Recruitment and retention challenges in breast cancer survivorship research: Results from a multisite, randomized intervention trial in women with early stage breast cancer. Cancer Epidemiol Biomarkers Prev, 2003; 12: 1087–90.

37. Kampshoff CS, Jansen F, van Mechelen W, et al. Determinants of exercise adherence and maintenance among cancer survivors: A systematic review. Int J Behav Nutr Phys Act, 2014; 11: 80.

38. Prescott RJ, Counsell CE, Gillespie WJ, et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess, 1999; 3: 1–143.

39. Bisschop CNS, Courneya KS, Velthuis MJ, et al. Control group design, contamination and drop-out in exercise oncology trials: A systematic review. PLoS One, 2015; 10.

40. Courneya KS, Segal RJ, Mackey JR, et al. Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: A multicenter randomized controlled trial. J Clin Oncol, 2007; 25: 4396–404.

Documents

UvA-DARE (Digital Academic Repository) Physical exercise ... · Wim H. van Harten Edwin Geleijn Marianne de Maaker-Berkhof Jolanda Schrama Maud M. Geenen Jetske M. Meerum Terwogt