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Cheryl Rock, PhD, RD; Graham Colditz, MD, DrPH; Wendy Demark-Wahnefried, PhD, RD; Tim Byers, MD, MPH
Study abstract

We propose a 4-year trial of 800 overweight or obese (BMI >27 and <40 kg/m2) women aged 21 and older who have been diagnosed with stage IC, II, or IIIA breast cancer. The primary specific aim of the project is: (1) To conduct a 4-year vanguard randomized controlled trial with the primary endpoint of weight loss among 800 breast cancer survivors, following all subjects for 2 years after randomization. Our primary hypothesis is that weight loss of at least 7% can be achieved and maintained in this target population. Secondary aims are: (2) To use the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to conduct a cost-effectiveness analysis that includes an assessment of the impact of the intervention on medical comorbid conditions; (3) To assess the impact of the intervention on quality of life (QOL), particularly physical functioning and fatigue; and (4) To prospectively collect blood and DNA samples to enable analysis of potential mechanisms and differential response across subgroups.

Study review

This study is examining the effects of a program that was created to help overweight breast cancer survivors lose weight by increasing their physical activity level and developing healthier eating habits. A total of 800 women will be participating in this study across the United States at four research sites: University of California, San Diego, Washington University School of Medicine in St. Louis, University of Alabama at Birmingham, and University of Colorado, Denver. The Call to Action for this study was sent to Army of Women members on June 1, 2011. When the researchers closed enrollment on May 16, 2012, the Army of Women had provided them with 98 women who were interested in enrolling in the study.

Resulting Publications: