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. 2017 Aug 24;2017(8):CD011152. doi: 10.1002/14651858.CD011152.pub2

Rogers 2015.

Methods Design: RCT. Follow‐up: 12 weeks and 6 months from baseline.
Participants Major inclusion criteria: with history of ductal carcinoma in situ (DCIS) or Stage 1‐3A breast cancer, not currently receiving or planning to receive chemotherapy or radiation therapy, 8 weeks or more post‐surgical procedure.
N = 222 (E: 110, C: 112)
 Mean age: E: 54.9 ± 9.3 years, C: 53.9 ± 7.7 years
Stage of breast cancer: E: stage DCIS (13, 11.8%), stage 1 (47, 42.7%), stage 2 (37, 33.6%), stage 3 (13, 11.8%); C: DCIS (12, 10.7%), stage 1 (46, 41.1%), stage 2 (41, 36.6%), stage 3 (13, 11.6%)
Interventions E: Physical (exercise) + Psychological (group discussion session)
Exercise: individual format, 12 supervised sessions in the first 6 weeks and 3 bi‐weekly face‐to‐face sessions in the second 6 weeks, 1‐hour supervised session covered warm‐up, aerobic walking on the treadmill, cool‐down, and stretching, self‐selected exercise after week 6, 30‐minute face‐to‐face session covered progress discussion, activity log sheets review, adherence and barriers assessment, heart rate monitor use assessment, and goals setting for the next two weeks; conducted by an exercise specialist.
Group discussion session: group format, 6 sessions in the first 8 weeks, topics included goal setting, journaling, exercise benefits, time and stress management, activity logs reviewed, barriers, benefits, safety, role model presentation, relapse and wrap‐up discussion; conducted by trained facilitators.
 C: received written materials
Outcomes Quality of life: FACT‐B
Others: activity monitoring by accelerometer, Godin Leisure‐Time Exercise Questionnaire, self‐reported exercise intensity, fitness by submaximal treadmill test
Notes RCT: Randomised controlled trial, C: Comparison, E: Experimental, DCIS: Ductal carcinoma in situ, FACT‐B: Functional Assessment of Cancer Therapy—Breast.
Dropouts or missing data where reported:
5 in experimental and 4 in comparison lost to follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation to one of the two study group conditions was completed using computer‐generated numbers in blocks of 4 within each recruiting site
Allocation concealment (selection bias) Low risk Random assignment was kept in sealed, opaque envelopes which were opened in the order in which participants completed baseline testing. Research staff members were unaware of the assignment until the envelope was opened
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel who delivered the intervention were not blinded to group allocation
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Participants could be aware of allocated interventions since they had to go through the intervention. Study did not provide enough information to allow judgment whether outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition somewhat balanced between groups. After treatment allocation, 5 participants from intervention group dropped out (due to time, family obligation, knee injury and fatigue). At 3‐month follow‐up, 4 were lost to follow‐up in intervention group (due to time and family obligation) and 2 were lost to follow‐up in control group (due to time and family obligation). At 6‐month follow‐up, 1 was lost to follow‐up in intervention group (due to being unable to contact) and 2 were lost to follow‐up in control group (due to time and stress). The study groups were balanced with regard to all characteristics except that a greater percentage of participants in the usual‐care group had been on hormonal therapy for ≤ 1 year (P = 0.02)
Selective reporting (reporting bias) Low risk Protocol was available and outcomes are reported as stated in protocol
Other bias High risk Participation rate was about 68.9%. Sampling bias likely present as non‐probability sampling used