Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer.

Reeves, Marina M.; Terranova, Caroline O.; Erickson, Jane M.; Job, Jennifer R.; Brookes, Denise S. K.; McCarthy, Nicole; Hickman, Ingrid J.; Lawler, Sheleigh P.; Fjeldsoe, Brianna S.; Healy, Genevieve N.; Winkler, Elisabeth A. H.; Janda, Monika; Veerman, J. Lennert; Ware, Robert S.; Prins, Johannes B.; Vos, Theo; Demark-Wahnefried, Wendy; Eakin, Elizabeth G.

Background: Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. Methods/design: Women (18-75 years; body mass index 25-45 kg/m²) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of intervention effects. Discussion: This trial will provide evidence needed to inform the wide-scale provision of weight loss, physical activity and dietary interventions as part of routine survivorship care for breast cancer survivors. (Continued on next page).

BREAST cancer treatment; TELEMEDICINE; RESEARCH protocols; WEIGHT loss; CANCER in women; CANCER-related mortality; RANDOMIZED controlled trials

BMC Cancer, 2016, Vol 16, p1

1471-2407

Academic Journal

10.1186/s12885-016-2858-0