van Waart 2014 high.
Methods | RCT, 3 groups Study start and stop dates: recruitment between March 2010 and December 2012 Length of intervention: approximately 20 weeks Length of follow‐up: 6 months |
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Participants | Patients with breast or colon cancer receiving adjuvant chemotherapy, 230 patients with breast cancer of 253 patients in total. Both intervention groups started exercising in the week of the first cycle of chemotherapy and continued until 3 weeks after the last cycle of chemotherapy. Mean length of chemotherapy 119.6 days (17 weeks) |
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Interventions | 1. Intervention group (n = 77): Onco‐Move, a relatively low‐intensity, home‐based, individualised, self managed physical activity program 2. Intervention group (n = 76): OnTrack, a relatively high‐intensity exercise program supervised by a physical therapist in an outpatient or general physical therapy practice setting 3. Control group (n = 77): usual care |
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Outcomes | Primary outcomes:
Secondary outcomes:
Outcomes assessed: before random assignment and start of chemotherapy (T0), at completion of chemotherapy (T1), and 6 months after completion of chemotherapy (T2) |
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Notes | Published protocol. Trial registration: The Netherlands Trial Register (NTR 2159) Funding: Supported by Alpe d'Huzes/Dutch Cancer Society Grant No. ALPE‐2009‐4299, the CZ Fund, Zilveren Kruis Achmea, and the Comprehensive Cancer Centre of the Netherlands. Conflicts of interest: 2 authors disclosed research funding by pharmaceutical companies |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned to Onco‐Move, OnTrack, or UC using the minimization method, which balanced groups with respect to age, primary diagnosis, treating hospital, and use of trastuzumab." |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants All outcomes | High risk | Not done |
Blinding of personnel/care providers All outcomes | High risk | Not reported. Comment: probably not done |
Blinding of outcome assessment (detection bias) Fitness outcomes | High risk | Not reported. Comment: probably not done |
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 | Outcome data were available for 204 participants (89%) directly after chemotherapy, and for 196 (85%) at the 6‐month follow‐up. ITT without imputation |
Selective reporting (reporting bias) | High risk | Differences between design paper and final publication (EQ‐5D, anthropometric measures and actigraph not mentioned in the final publication). Chemotherapy completion rate mentioned as outcome in the final publication, but not in the design paper |
Group similarity at baseline | Low risk | Baseline characteristics were balanced across groups |
Adherence | High risk | On average, participants in OnTrack attended 71% of the planned sessions. On the basis of the exercise diary, 48% of the OnTrack group and 55% of the Onco‐Move group followed the recommendations regarding daily activity levels at least 75% of the time |
Contamination | Unclear risk | Not reported |