Yun 2017.

Methods	Design: randomised controlled trial Country: South Korea Accrual dates: April 2012 to August 2013 Trial Reg: NCT01527409
Participants	Number randomised: 248 546 eligible patients, 298 excluded; Leach Program group: 115 (69.3%) participants completed the 12‐month course at 3 months, and 117 (70.5%) at 6 to 12 months; UC group, 60 (73.2%) participants completed the course at 3 months and 57 (71.3%) at 12 months Inclusion: ≥ 20 years old. Platelet count ≥ 100,000/mm³. Serum haemoglobin ≥ 10 g/dL. Not already met 2 or more behavioural goals aimed for in the study. Energy expenditure achieved by at least moderate exercise for at least 150 minutes/week. Intake of ≥ 5 servings of fruits and vegetables per day. Total score > 72 points in the Post Traumatic Growth Inventory Exclusion: currently receiving cancer treatment. Progressive malignant disease or recurrent, metastasised, or additional primary cancer. Condition that might compromise adherence to an unsupervised exercise programme (e.g. uncontrolled congestive heart failure or angina, recent myocardial infarction, breathing difficulties requiring oxygen use or hospitalisation, inability to walk without a walker or wheelchair, planning to receive hip or knee replacement surgery). Condition that could interfere with ingestion of a diet high in vegetables and fruits (e.g. kidney failure, need for chronic warfarin). Serious psychological disorder (e.g. bipolar disease, schizophrenia, eating disorder). Infection (body temperature ≥ 37.2°C or WBC ≥11,000 mm³). Visual or motor dysfunction. Pregnant Gender: male 42 (20.39), female 164 (79.61) Age: mean 50.68 (SD 9.43) years Type of cancer: stomach (n = 51), lung (n = 5), breast (n = 123), colorectal (n = 11), gynaecological (n = 9), other (n = 1) Therapy previously received for cancer: Missing ‐ 10, surgery ‐ 195 (99.49), radiotherapy‐ 100 (51.02), chemotherapy ‐ 119 (60.71), hormonal therapy ‐ 51 (43.59) Cancer stage: stage 0 ‐ 5 (2.51), stage 1 ‐ 100 (52.67), stage 2 ‐ 66 (33.17), stage 3 ‐ 20 (10.05), stage 4 ‐ 2 (1.01), other (5/6) ‐ 6 (3.02) Ethnicity: Korean Education: high school graduate or less 105 (51.47), college graduate 99 (48.53)
Interventions	Comparison: LEACH (physical activity, diet, and distress) programme vs usual care Intervention: 1‐hour health education workshop (physical activity, dietary habits, and distress management) and 3‐hour leadership workshop (Seven Habits of Highly Effective People With Cancer). Next, the Intervention group was also offered individual coaching by telephone for a 24‐week period Control: encouraged to continue their usual care and given a health education booklet on physical activity, dietary habits, and distress management
Outcomes	Physical activity: measured in METs (kcal/kg/week) Diet: a validated questionnaire on fruit and vegetable intake Post‐traumatic growth: measured using the 21‐item Post‐Traumatic Growth Inventory Duration of follow‐up: outcomes were measured at 0, 3, 6, and 12 months, but data from the 6‐month period were not included in the analysis due to lack of participants
Notes	Funding: national cancer centre, national R&D programme for cancer control, ministry of health and welfare, Republic of Korea
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	With the aid of a computerised random number generator, we randomly assigned eligible participants
Allocation concealment (selection bias)	Unclear risk	With the aid of a computerised random number generator, we randomly assigned eligible participants
Blinding of participants and personnel (performance bias) Objective outcomes	Unclear risk	No objective outcome measures
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Participants and personnel not blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Unclear risk	No objective outcome measures
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Self‐report quality of life
Incomplete outcome data (attrition bias) Objective	Unclear risk	No objective outcome measures
Incomplete outcome data (attrition bias) Subjective	High risk	All participants accounted for, but 30% dropout in control and intervention groups
Selective reporting (reporting bias)	Unclear risk	Protocol could not be located; insufficient information to make a judgement
Other bias	Unclear risk	Insufficient information to permit a judgement