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. 2016 Sep 21;2016(9):CD005001. doi: 10.1002/14651858.CD005001.pub3

Travier 2015.

Methods RCT, 2 groups
Study start and stop dates: conducted between 2010 and 2013
Length of intervention: 18 weeks
Length of follow‐up: 18 weeks
Participants Patients with breast or colon cancer undergoing cancer treatment (204 breast cancer patients of 237 patients in total), intervention started 6 weeks postdiagnosis. Unpublished data (final values) for breast cancer patients used in the analyses of this review
Interventions Intervention (n = 102): supervised group exercise (aerobic and resistance) program based on Bandura’s social cognitive theory
Control (n = 102): asked to maintain their habitual physical activity pattern
Outcomes Primary outcome:
  • fatigue: MFI and FQL


Secondary outcomes:
  • HRQoL: SF‐36

  • cancer‐specific quality of life: EORTC QLQ‐C30 (Version 3)

  • anxiety and depression: HADS (Dutch version)

  • physical fitness: VO2 peak; peak power output

  • strength: thigh muscle strength, handgrip strength

  • body composition: BMI, body fat distribution

  • physical activity level: Short QUestionnaire to ASsess Health enhancing physical activity (SQUASH)

  • self efficacy about the performance of physical activity (design paper)

  • perceived impact of the disease on participation and autonomy assessed: Impact on Participation and Autonomy (IPA) questionnaire (design paper)

Notes Trial registration: Current Controlled Trials (ISRCTN43801571), Dutch Trial Register (NTR2138)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Concealed computer‐generated randomisation, 1:1 ratio, stratified per age, adjuvant treatment, use of tissue expander, and hospital by sequential balancing
Allocation concealment (selection bias) Low risk "After the patient signed informed consent, the researcher (who was with the patient) called the data management department and provided the participants study number and the information necessary for stratification. The data manager then performed the randomization using a computer program and informed the researcher about the allocation (and also noted the allocation in the randomization log)."
Blinding of participants 
 All outcomes High risk "not possible"
Blinding of personnel/care providers 
 All outcomes High risk Not reported
Comment: probably not done
Blinding of outcome assessment (detection bias) 
 Fitness outcomes Low risk Outcome measures were assessed by researchers not involved with the participants
Blinding of outcome assessment (detection bias) 
 All outcomes except fitness outcomes High risk Self reported items
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Drop‐out after 18 weeks:
  • intervention group: 13/102 (12.7%)

  • control group: 9/102 (8.8%)


Follow‐up: high risk
Drop‐out after 36 weeks:
  • intervention group: 15/102 (14.7%)

  • control group: 25/102 (24.5%)

Selective reporting (reporting bias) High risk Design paper published.
EQ‐5D, IPA (Impact on Participation and Autonomy), self efficacy (items based on social cognitive theory) mentioned in the design paper, but not in the publication
Group similarity at baseline High risk "were comparable on most characteristics"
Comment: More women in the intervention group were highly educated, had triple‐negative breast cancer, and were postmenopausal.
Total physical activity levels tended to be higher in the control group
Adherence Low risk Participation in 83% (IQR 69% to 91%) of the classes.
Reported to be physically active in 11 (IQR 6 to 14) of 18 weeks
Contamination High risk High level of physical activity reported by 56% of the controls at 18 weeks