Brown 2018.
| Methods |
Design: phase II randomised trial Country: USA Accrual dates: NR Trial Reg: NCT01978899 |
| Participants |
Number randomised: 60 Inclusion: body mass index (BMI) > 25.0 kg/m²; completion of all surgery, chemotherapy, and/or radiation at least 1 month before study enrolment (concurrent treatment with adjuvant hormonal or biologic therapies was acceptable); ECOG performance status of 0 (fully active without restriction) or 1 (restricted in physically strenuous activity, but ambulatory); and ability to walk 2 city blocks and to speak and read English Exclusion: other serious medical conditions such as unstable cardiovascular disease or digestive disorders that would preclude participation in a physical activity and dietary intervention Gender: female n = 58, male n = 3 Age: 52 ± 9 years Type of cancer: Breast: intervention 24 (80%), control 22 (73%) Gynecological: intervention 0 (0%), control 4 (13%) Hematological: intervention 2 (7%), control 2 (7%) Genitourinary: intervention 1 (3%), control 1 (3%) Gastrointestinal: intervention 1 (3%), control 1 (3%) Sarcoma: intervention 2 (7%), control 0 (0%) Therapy previously received for cancer: Chemotherapy: intervention 19 (63%), control 21 (70%) Radiation: intervention 22 (73%), control 18 (60%) Hormone: intervention 20 (67%), control 22 (73%) Cancer stage: NR Ethnicity: White:intervention 26 (87%), control 26 (87%) Black: intervention 2 (7%), control 1 (3%) Other: intervention 2 (7%), control 3 (10%) Education: High school or less: intervention 1 (3%), control 4 (13%) Some college: intervention 5 (17%), control 5 (17%) College degree or more: intervention 24 (80%), control 21 (70%) |
| Interventions |
Comparison: weight loss intervention vs wait‐list control Intervention: weight loss intervention participated in a 15‐week, in‐person, group‐based programme that was led by a health coach with a background in nutrition and an exercise physiologist. Behavioural content of the programme described herein was modelled after the Lifestyle Intervention in Adjuvant Treatment of Early Breast Cancer (LISA) study Control: wait‐list control |
| Outcomes | Primary aim of the study was to evaluate the efficacy of the intervention in lowering body mass. Secondary aims of the study were to evaluate effects of the intervention on body composition, physical fitness, and concentrations of serum biomarkers linked to cancer risk and prognosis |
| Notes | Funding: a grant from the Friends of Dana‐Farber Cancer Institute |