title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Australian and New Zealand Clinical Trial Registry (ANZCTR) - ACTRN12612000997853 (Registered 18 September 2012).
authors: School of Public Health, The University of Queensland, Brisbane, Australia. m.reeves@sph.uq.edu.au.
authors: Marina M
authors: MM
authors: Reeves
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: Caroline O
authors: CO
authors: Terranova
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: Jane M
authors: JM
authors: Erickson
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: Jennifer R
authors: JR
authors: Job
authors: School of Public Health, The University of Queensland, Brisbane, Australia.|School of Medicine, Children's Nutrition Research Centre, The University of Queensland, Brisbane, Australia.
authors: Denise S K
authors: DS
authors: Brookes
authors: Icon Cancer Care, Wesley Medical Centre, Brisbane, Australia.
authors: Nicole
authors: N
authors: McCarthy
authors: Department of Nutrition & Dietetics, Princess Alexandra Hospital, Brisbane, Australia.|Mater Research Institute, University of Queensland, Brisbane, Australia.
authors: Ingrid J
authors: IJ
authors: Hickman
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: Sheleigh P
authors: SP
authors: Lawler
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: Brianna S
authors: BS
authors: Fjeldsoe
authors: School of Public Health, The University of Queensland, Brisbane, Australia.|Baker IDI Heart and Diabetes Institute, Melbourne, Australia.|School of Physiotherapy, Curtin University, Perth, Australia.
authors: Genevieve N
authors: GN
authors: Healy
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: Elisabeth A H
authors: EA
authors: Winkler
authors: Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.
authors: Monika
authors: M
authors: Janda
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: J Lennert
authors: JL
authors: Veerman
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: Robert S
authors: RS
authors: Ware
authors: Mater Research Institute, University of Queensland, Brisbane, Australia.
authors: Johannes B
authors: JB
authors: Prins
authors: Institute for Health Metrics and Evaluation, University of Washington, Seattle, USA.
authors: Theo
authors: T
authors: Vos
authors: Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, USA.
authors: Wendy
authors: W
authors: Demark-Wahnefried
authors: School of Public Health, The University of Queensland, Brisbane, Australia.
authors: Elizabeth G
authors: EG
authors: Eakin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy; D002985:Clinical Protocols; D015444:Exercise; D005260:Female; D006306:Health Surveys; D006801:Humans; D008019:Life Style; D008875:Middle Aged; D009367:Neoplasm Staging; D015596:Nutrition Assessment; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D017741:Survivors; D015431:Weight Loss; D055815:Young Adult
keywords: Breast cancer survivors; Diet; Lifestyle intervention; Nutrition; Physical activity