Harrigan 2016.
| Methods |
Design: randomised controlled trial: 3 arms Country: USA Accrual dates: June 2011 to December 2012 Trial Reg: NR |
|
| Participants |
Number randomised: 100 825 screened via telephone, 429 ineligible, 296 not interested, 33 in‐person counselling, 34 telephone counselling, 33 usual care Inclusion: breast cancer survivors with BMI > 25 kg/m², diagnosed in the 5 years before enrolment with stage 0 to 3 breast cancer, had completed chemotherapy and/or radiation therapy at least 3 months before enrolment. Physically able to exercise, agree to be randomly assigned, give informed consent to participate in all study activities. Had to be accessible by phone and English literate Exclusion: women who were pregnant or intending to become pregnant in the next year, recent stroke or myocardial infarction, severe uncontrolled mental illness Gender: all female Age: 59.0 mean (SD 7.5) years Type of cancer: breast Adjuvant treatment after surgery: none: n = 15 (15%), radiation only: n = 36 (36%), chemotherapy only: n = 22 (22%), radiation and chemotherapy: n = 54 (54%) Cancer stage: 0: n = 15 (15%), 1: n = 51 (51%), 2: n = 24 (24%), 3: n = 7 (7%), unknown: 3 (3%) Ethnicity: non‐Hispanic white: n = 91 (91%) Baseline physical activity: moderate to vigorous‐intensity physical activity (minutes/week): 99 mean (SD 127) Education: high school degree: n = 8 (8%), some college: n = 26 (26%), college degree: n = 29 (29%), graduate degree: n = 37 (37%) |
|
| Interventions |
Comparison: in‐person counselling vs telephone weight loss counselling vs usual care Intervention: weight loss intervention adapted from the diabetes prevention programme. Both in‐person and telephone counselling groups received the same lifestyle intervention Control: usual care group received the American Institute for Cancer Research nutrition and physical activity brochures and were referred to the Yale Cancer Centre Survivorship clinic. ITT was used |
|
| Outcomes |
Diet: 120‐item food frequency questionnaire Height: stadiometer (nearest 0.1 cm) Weight: measured while wearing light indoor clothing, without shoes (nearest 0.1 kg) Waist: measurement taken at smallest waist circumference (nearest 0.1 cm) Body fat: dual‐energy x‐ray absorptiometry scans (DEXA) performed to assess body fat with a Hologic 4500 scanner Serum biomarkers: fasting (> 12 hours) blood draw was performed. Serum samples were stored at ‐80 degrees C until assayed Duration of follow‐up: 6 months |
|
| Notes | Funding: American Institute of Cancer Research | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Permuted‐block randomisation with random block size performed by study biostatistician |
| Allocation concealment (selection bias) | Low risk | Participants randomly assigned by blinded study staff using unmarked envelopes |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | No blinding; outcome is not likely to be influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | Subjective outcomes not reported |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Study staff blinded to randomisation and lab technicians blinded to treatment assignment |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Subjective outcomes not reported |
| Incomplete outcome data (attrition bias) Objective | High risk | Attrition was 49% and was uneven across groups |
| Incomplete outcome data (attrition bias) Subjective | Unclear risk | Subjective outcomes not reported |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
| Other bias | Low risk | No other concerns |