Courneya 2003a.
Study characteristics | ||
Methods | Study design: cluster RCT, where clusters were psychotherapy classes Number randomized: 108; 60 (in 11 classes) to the exercise group and 48 (in 11 classes) to the control group Study start and stop dates: the group psychotherapy classes were conducted between September 1998 and April 2001 Length of intervention: 10 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer, 40.6%; colon cancer, 9.4%; ovarian cancer, 5.2%; stomach cancer, 4.2%, melanoma, 4.2%; Hodgkin disease, 3.1%; NHL, 3.1%; brain cancer, 3.1%; lung cancer, 3.1%; other, 15.6%; missing, 8.3% Time since cancer diagnosis, mean (SD) months:
Time beyond active treatment: not reported, although 43.5% of participants in exercise group and 45.2% of participants in control group were still receiving treatment Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender, %:
Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level, % completing university:
SES, % with family income > USD40,000:
Employment status, % currently employed:
Comorbidities: not reported Past exercise history, mean (SD) minutes participants engaged in mild, moderate, or strenuous exercise:
On hormone therapy: not reported |
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Interventions | 60 participants assigned to the personalized exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: goal was to achieve 65% to 75% of estimated HR maximum as soon as safely possible Frequency: 3 to 5 times per week Duration of individual sessions: 20 to 30 minutes Duration of exercise program: 10 weeks Total number of exercise sessions: variable, but maximum would be 50 sessions Format: individual Facility: home, with group psychotherapy classes offered in facility (Cross Cancer Institute) Not professionally led 48 participants assigned to the control group, including:
Adherence: 51/60 participants completed the 10‐week intervention; 43/51 (84.3%) achieved the minimum exercise prescription of 60 minutes of moderate to strenuous exercise per week and 16/51 (31.4%) achieved the optimum exercise prescription of 150 minutes of moderate to strenuous exercise per week. Total minutes of exercise, mean (SD) 196.65 (149.56) minutes Contamination of control group: mean (SD) minutes when participants in the control group participated in exercise 100.91 (104.24) minutes |
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Outcomes | No primary outcome was identified. QoL outcomes included:
Outcomes were measured at baseline and 10 weeks:
Subgroup analysis: several subgroup analyses were prespecified and conducted Adverse events: none reported |
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Notes | Country: Canada Funding: NIH, Canadian Institutes of Health Research, NCIC, CCS, CCS/NCIC Sociobehavioral Cancer Research Network |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation sequence was generated using a random numbers table |
Allocation concealment (selection bias) | High risk | Allocation was not completely concealed. It was concealed from the fitness appraiser but not from other study personnel |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, it was not possible to blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Study personnel and outcome assessors were not masked or blinded to the study interventions |
Incomplete outcome data (attrition bias) All outcomes | High risk | Although stated that analyses were conducted on an ITT basis, the treatment of missing data was not described. There was substantial attrition from the study in both study groups |
Selective reporting (reporting bias) | Low risk | There is no evidence of selective reporting of outcomes |
Other bias | Low risk | The trial appears to be free of other problems that could put it at a high risk of bias |