Cadmus 2009.

Study characteristics
Methods	Study design: RCT Number randomized: 75; 37 to the exercise group and 38 to the control group Study start and stop dates: March 2004 to July 2006 Length of intervention: 6 months Length of follow‐up: to end of the intervention
Participants	Type cancer: breast cancer, Stage 0 to IIIA Time since cancer diagnosis, mean (SD) weeks: exercise group: 11.1 (4.5) weeks control group: 11.0 (5.2) weeks Time in active treatment: scheduled for chemotherapy or radiation therapy or within first 2 weeks of starting chemotherapy or radiation therapy Inclusion criteria: pre‐ or postmenopausal 35 to 75 years old Eligibility criteria related to interest or ability, or both, to exercise: physically able to exercise physician consent to begin an exercise program Exclusion criteria: diagnosis of recurrent or other primary cancer event current smoker Gender: female Current age, mean (SD) years: exercise group: 54.5 (8.2) years control group: 54.0 (10.9) years Age at cancer diagnosis: not reported Ethnicity/race, %: exercise group: non‐Hispanic white, 96% control group: non‐Hispanic white, 92% Education level, %: exercise group: college degree or higher, 68% control group: college degree or higher, 72% SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: not reported On hormone therapy: exercise group, 56% control group, 68% BMI, mean (SD): exercise group: 27.9 (5.3) control group: 27.5 (5.4) Body fat, mean (SD): exercise group: 36.7% (5.9%) control group: 38.0% (6.1%)
Interventions	25 participants assigned to the exercise intervention, including: home‐based supervised exercise program with weekly telephone calls, information, heart monitor, activity logs Type exercise (aerobic/anaerobic): unclear, up to the women's choice Intensity of the experimental exercise intervention: 60% to 80% of predicted maximal HR Frequency: 5 days per week Duration of individual sessions: 30 minutes Duration of exercise program: 6 months Total number of exercise sessions: 120 sessions Format: individual Facility: home Professionally led by "staff" Adherence, mean (SD) minutes of activity per week: 144 (75) minutes compared with target of 150 minutes with 64% meeting goal 25 participants assigned to control group, including: usual exercise Contamination of control group: not reported
Outcomes	No primary outcome was identified. QoL outcomes included: happiness, assessed using the 2‐item Fordyce Happiness Measure self‐esteem, assessed using the Rosenberg Self‐Esteem Scale depression, assessed using the CES‐D scale anxiety, assessed using the STAI stress, assessed using the Cohen's 10‐item Perceived Stress Scale QoL, assessed using FACT‐B QoL, assessed using the MOS SF‐36 Outcomes were measured at baseline and 6 months: exercise group: n = 25 at baseline, n = 22 at 6 months control group: n = 25 at baseline, n = 23 at 6 months Subgroups: HRQoL level at baseline, by weight loss, or body fat, or both Adverse events: none reported
Notes	Country: US Funding: Lance Armstrong Foundation, American Cancer Society, Susan G. Komen. National Institutes of Health
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomization code
Allocation concealment (selection bias)	Low risk	"The randomization code was obtained by the principal investigator (who was not involved in recruitment or data collection) only after baseline measures for that individual had been completed and staff conducting clinic visits did not have access to the randomization program"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from the participants
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	Low risk	ITT analysis performed and baseline values were carried forward for the 5 women who had missing 6‐month data
Selective reporting (reporting bias)	Low risk	There appears to be no 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