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 |
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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 Unpublished data (final values) for breast cancer patients used in the analyses of this review | |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 |
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Outcomes | Primary outcome:
Secondary outcomes:
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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:
Follow‐up: high risk Drop‐out after 36 weeks:
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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 |