Basen‐Enquist 2006.

Methods	Study design: single‐centre RCT Number randomised: 60; 30 to intervention, 25 to standard care Study start: April 2003; stop date: April 2004 Length of intervention: 6 months Length of follow‐up: to end of intervention Country: USA
Participants	Age, years (mean SD): Intervention: 55.7 (11.1) Control: 54.4 (11.7) Stage, n (%): Intervention: DCIS, 9 (27); stage I, 9 (27); stage II, 7 (21); stage III, 8 (24); stage IV, 1 (3); missing, 1 Control: DCIS, 4 (17); stage I, 8 (33); stage II, 8 (33); stage III, 3 (13); stage IV, 1 (4); missing, 1 Inclusion criteria: • Within 7 years of a breast cancer diagnosis • No longer receiving treatment for breast cancer (except hormone therapy) • Not engaging in focussed moderate physical activity for 30 minutes or longer a day most days of the week Exclusion criteria: • Clearance received from physician to ensure that they had no medical conditions contraindicating moderately intensive exercise
Interventions	35 participants assigned to exercise intervention: Participants in the lifestyle programme attended 90‐minute group meetings each week for 16 weeks, and every other week for 8 weeks (21 sessions total). Behaviour change methods were based on the transtheoretical model. Participants were taught to assess their motivational readiness for physical activity, which they did every 4 to 5 weeks, and received booklets about increasing physical activity matched to their stage of readiness. Intervention sessions emphasised information and skills such as benefits of physical activity, making small changes, overcoming barriers, goal setting, rewarding yourself, and self‐monitoring. Several methods of self‐monitoring were used, including recording minutes of activity and recording steps using a pedometer. Information and skills were sequenced so that cognitive methods (e.g. recognising benefits of physical activity) were presented in earlier sessions and behavioural methods (e.g. monitoring steps, rewarding yourself) were presented in later sessions. Adherence: Among those who started the intervention, the mean number of sessions attended was 14.6 out of 21 (SD 5.1), with a range of 2 to 21 sessions. 25 participants assigned to control: During 6‐month intervention period, standard care participants received 2 mailings of the same written material as the intervention group, which included topics related to breast cancer survivorship but did not address physical activity, and standard care participants did not meet as a group.
Outcomes	Outcomes: Physical activity during the past week assessed via a 7‐day physical activity recall questionnaire (7‐ DPAR), an interviewer‐administered measure Physical performance assessed via a 6‐minute endurance walk test; a 50‐foot walk test; a timed sit‐to‐stand test; a timed reach‐up test; and a forward‐reach test Anthropometric measures such as BMI, hip and waist circumferences Quality of life assessed via Medical Outcomes 36‐Item Short Form Health Survey Patient satisfaction measured via a brief questionnaire administered to participants in the lifestyle programme during the last session of the programme Lymphoedema assessed by a physical therapist who measured arm girth circumferentially at predetermined bilateral points. Jobst measuring tapes were used to take circumferential measurements every inch and a half, starting at the elbow and moving toward the shoulder and toward the wrist. Numbers of participants assessed: Intervention: baseline, 35; at 6 months, 28 Control: baseline, 25; at 6 months, 23 Adverse events: The intervention group did not show a significantly larger number of increases in arm circumference compared with the standard care group.
Notes	Trial registration link: none available Trial authors contacted: no Intention‐to‐treat analysis: yes Funding: grants R21 CA89519 and R25 CA57730 from the National Cancer Institute
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Participants were assigned to study arms using a form of adaptive randomization called minimization”.
Allocation concealment (selection bias)	Unclear risk	Whether the allocation was concealed is unclear.
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 participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Staff conducting assessments were blind to participants’ study condition.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants who were randomised were included in the analysis, regardless of their attendance at intervention sessions. Data for participants who did not complete the 6‐month assessment were imputed based on regression models predicting outcomes in the remaining sample, using covariates and design variables.
Selective reporting (reporting bias)	Unclear risk	No selective reporting of outcomes is apparent.
Other bias	High risk	Imbalance between numbers allocated to intervention and control groups could potentially lead to additional bias.