Mock 2001.

Study characteristics
Methods	Study design: RCT Number randomized: 52, numbers assigned to exercise or control group not reported Study start and stop dates: not reported Length of intervention: duration of treatment; 6 weeks for radiation therapy and 4 to 6 months for chemotherapy Length of follow‐up: to end of the intervention
Participants	Type cancer: breast cancer Stage, %: Stage I, 54%; Stage II, 40%; Stage IIIa, 6% Time since cancer diagnosis: not reported Time in active treatment: In treatment Inclusion criteria: recently treated for Stage I to IIIa breast cancer by definitive surgery scheduled to receive outpatients adjuvant radiation (64%) or chemotherapy (36%) Eligibility criteria related to interest or ability, or both, to exercise: concurrent major health problem that would contraindicate an exercise program Exclusion criteria: none reported Gender: female Current age: mean (range) years: 47.98 (28 to 75) years Age at cancer diagnosis: not reported Ethnicity/race, n (%): white, 43 (86%); African American, 6 (12%); Hispanic, 1 (2%) Education level, mean (range) years of education: 14.76 (8 to 20) years SES: not reported Employment status, n (%): full‐time, 24 (48%); part‐time, 9 (18%; unemployed, 17 (34%) Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported
Interventions	Number of participants assigned to the exercise intervention not reported. The exercise intervention included: individualized walking program, with contact from clinic staff every 2 weeks to check on progress based on Levine conservation model Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: not reported Frequency: 5 or 6 sessions per week Duration of individual sessions: 10 to 15 minutes to start, advancing to 30 minutes Duration of exercise program: to end of therapy Total number of exercise sessions: varied Format: individual Facility: home Not professionally led Adherence: 33% did not maintain a minimum of 90 minutes/week in ≥ 3 daily sessions Number of participants assigned to control group not reported. The control intervention included: usual care, with contact from study staff every 2 weeks for attention control Contamination of control group: 50% were actively exercising during the study period
Outcomes	No primary outcome was identified. QoL outcomes included: fatigue, assessed using Modified PFS, including overall fatigue and 4 fatigue dimensions: temporal, severity, affective, and sensory physical function, assessed using 12‐MWT activity level rating scale MOS SF‐36 physical function emotional distress, assessed using the Profile of Moods State questionnaire global HRQoL and QoL domains, assessed using the MOS SF‐36 and following subscales physical functioning social functioning role functioning physical limitations role functioning‐emotional limitations bodily pain general mental health vitality general health perceptions Outcomes were measured at baseline and end of the intervention, but numbers by treatment group with data at each time point were not reported Subgroup analysis: owing to poor adherence in the experimental group and high contamination in the control group, the analyses reported were not based on randomization but based on high‐walkers versus low‐walkers Adverse events: none reported Cost: Described as "low cost" but no data reported
Notes	Country: US Funding: Fatigue Initiative in Research, Education Grant from the Oncology Nursing Society Foundation through a donation from Ortho Biotech
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Unclear risk	Sealed envelopes
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	High risk	No ITT analyses were performed
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