Demark‐Wahnefried 2007.

Methods	Design: randomised, single‐blinded, parallel‐group, attention‐control active treatment‐controlled phase II clinical trial Country: USA Accrual dates: July 2002 to October 2005 Trial Reg: NR
Participants	Number randomised: 543 Out of 2155, 543 were eligible (1612 excluded), 271 were randomised to the intervention arm, and 272 were randomised to the control arm At 1‐year follow‐up, 519 were included in the analysis: 18 in the intervention arm were lost to follow‐up, and 6 in the control arm were lost to follow‐up. 271 in the intervention arm and 272 in the control arm were included in 1‐year follow‐up ITT analysis At 2‐year follow‐up, 489 were included in the analysis: from 1‐year to 2‐year follow‐up, an additional 30 were lost to death, illness, no longer wanting to participate, and unable to be contacted Inclusion: early‐stage (in situ, localised, or regional) breast and prostate cancer, identified within 9 months of diagnosis Exclusion: conditions precluding unsupervised exercise (i.e. uncontrolled congestive heart failure or angina, recent myocardial infarction, or breathing difficulties requiring oxygen use or hospitalisation; walker or wheelchair use; plans to have hip or knee replacement); conditions precluding a high fruit and vegetable diet (kidney failure or chronic warfarin use); progressive cancer or additional primary tumour; non‐English speakers/writers Age: range 22 to 85, 57 mean (SD 10.8) years Gender: 44% male, 56% female from all who responded; 29% of respondents were ineligible Type of cancer: breast and prostate Therapy previously received for cancer: 44% radiation therapy including brachytherapy, 27% chemotherapy, 85% surgery Cancer stage: Breast: 8% stage 0, 29% stage I, 17% stage II, 3% stage III Prostate: 17% stage 0, 23% stage II, 3% unknown Ethnicity: 83% white; 13% black; 4% other Baseline physical activity: minutes of activity per week Intervention: 53.4 mean (SD 112.7) Control: 44.6 mean (SD 89.1) Education: 12% < high school graduate, 30% some college or associate experience, 58% college graduate/post graduate
Interventions	Comparison: telephone counselling and tailored print materials on diet and exercise vs general health counselling Intervention: participants received sequentially tailored mailed materials, in 2 behavioural domains. These were consistent with the transtheoretical model, and health messages were customised to the participant’s stage of readiness to promote behaviour change Control: participants received standardised mailed materials on improving cancer survivors’ diet and exercise behaviours. The intervention was delivered over 10 months and involved personalised mailed printed materials promoting fruit and vegetable consumption followed by 7 newsletters at 6‐weekly intervals
Outcomes	Dietary changes: telephone interviews using diet history questionnaire (Diet Quality Index score, total percentage of calories from fat, total percentage of calories from saturated fat, number of daily servings of fruits and vegetables) Changes in BMI: telephone interview using self‐reported data (kg/m²). Measured heights and weights performed on a 23% subsample using wall mounted stadiometer and calibrated platform scales (weight expressed as BMI; kg/m²) QoL: telephone interview using Functional Assessment of Cancer Therapy ‐ General (FACT‐G) score Biochemical measures: phlebotomy performed on a 23% subsample after a 4‐hour fast. Analysis of HDL cholesterol (mg/dL), C‐reactive protein, insulin, IL‐6, and alpha‐carotene No. of healthy eating changes made: telephone interview No. of lifestyle behaviour changes made: telephone interview Changes in level of physical activity: telephone interview using 7‐day physical activity recall (minutes per week) No. of adverse events: toll‐free number provided for participants to ring and record events at any time. Events categorised by a committee blinded to random assignment status as serious (life‐threatening, permanently debilitating, or requiring hospitalisation overnight) or non‐serious (all other events) Participants' opinion on helpfulness of the intervention: telephone interview using 5‐point Likert scale from completely to not at all helpful (no direction stated – assume 1 is completely helpful) Duration of follow‐up: 24 months
Notes	Funding: National Institutes of Health, American Institute of Cancer Research, Susan G. Komen Foundation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random assignment lists were generated by a project statistician using software of the Cancer and Leukaemia Group B
Allocation concealment (selection bias)	Low risk	Implemented in a blinded fashion at an office that was physically removed from the main study office
Blinding of participants and personnel (performance bias) Objective outcomes	Unclear risk	No objective outcomes appropriate for this review
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	No blinding; outcome was patient self‐reported and therefore is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Objective outcomes	Unclear risk	No objective outcomes appropriate for this review
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	No blinding of outcome assessment; outcome measurement was patient self‐reported and therefore is likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) Objective	Unclear risk	No objective outcomes appropriate for this review
Incomplete outcome data (attrition bias) Subjective	Low risk	Attrition was low ‐ 4.4% at 1 year and 10% at 2 years. ITT was used in the final analysis, inputting no change in behaviour across time for dropouts
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	None