Courneya 2016.
| Study characteristics | ||
| Methods | Study design: RCT Study location: Canada and Australia Inclusion criteria: 1. high risk stage II or stage III colon cancer 2. received adjuvant chemotherapy within the past 2–6 months 3. an Eastern Cooperative Oncology Group performance status of 0 or 1 4. are not currently meeting physical activity guidelines (i.e. the equivalent of 150 minutes/week of moderate‐intensity exercise) 5. able to complete at least two stages of a submaximal treadmill test Exclusion criteria: not reported |
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| Participants | Number randomised: 273; 136 to a structured exercise programme (SEP) and 137 to health education materials (HEM) Baseline imbalances: no significant differences at baseline Withdrawals and exclusions: 62 excluded from primary analysis at year 1 (211 analysed; 105 in the control (HEM) group, 106 in the intervention group) Age, n (%) analysed group: less than 65: Control (HEM): 71 (68%) Intervention: 71 (67%) Gender, n (%) analysed group: Control (HEM) male; 46 (44%), female 59 (56%) Intervention; male 46 (43%), female 60 (57%) Ethnicity: not reported Comorbidities: not reported SES: not reported Cancer type: colon Cancer stage, n (%): High risk stage II: control (HEM): 12 (11%) Intervention: 14 (13%) Stage III: control (HEM): 93 (89%) intervention: 92 (87%) Type of treatment: 100% received chemotherapy Receiving or finished treatment: finished Time beyond treatment: 2‐6 months Time since diagnosis, median (range): Control; 12 (0‐16) months Intervention; 12 (8‐17) months |
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| Interventions |
Physical activity description: Frequency: biweekly face‐to‐face counselling sessions combined with supervised exercise, with the option of an additional supervised exercise session during alternate weeks Intensity: individual choice Time: individual choice Type: individual choice Volume/progression: increase recreational aerobic physical activity by at least 10 MET‐hours/week from baseline in the first 6 months and sustain this change for 3 years Length of intervention: 3 years altogether (three phases‐ phase 1 adoption, 2 consolidation and 3 maintenance) Control group: health education material (HEM) intervention receive general health education materials promoting physical activity and healthy nutrition as well as standard surveillance follow‐up Setting: not reported Supervised or self‐directed: supervised or telephone support Co‐interventions: HEM |
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| Outcomes | 1. Disease‐free survival
2. Overall survival
3. Patient reported outcomes (using SF‐36, FACIT‐F, PSQI, and HADS questionnaires)
4. Physical fitness (i.e. body mass index, hip and waist circumference, cardiovascular fitness, and physical function)
5. Physical activity levels (TPAQ)
6. Safety profile according to NCI CTCAE version 3.0
7. Correlative biological markers including biochemical and molecular markers associated with insulin‐related growth factor and cytokines associated with the mechanisms of fatigue
8. Economic evaluations including cost‐effective analysis and cost utility analysis
9. Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire Time points measured: baseline and 1 year Time points reported: baseline and 1 year Adverse events: not reported |
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| Notes | Funding sources: Canada Research Chairs Program Alberta Innovates‐Health Solutions, Alberta Cancer Foundation's Weekend to End Women's Cancers Breast Cancer Chair and Canadian Cancer Society Research Institute National Health and Medical Research Council (Australia) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | This is an open‐label study. However, it is not possible to blind participants and personnel due to the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’ |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data balanced across intervention groups with reasons. 22% attrition |
| Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
| Other bias | Low risk | The study appears to be free of other problems that could put it at a high risk of bias |