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Design of FRESH START: a randomized trial of exercise and diet among cancer survivors
Wendy Demark-Wahnefried1, Elizabeth C Clipp, Colleen McBride
1Duke University Medical Center (DUMC), Durham, NC 27710, USA. demar001@mc.duke.edu
Purpose:
FRESH START is a randomized controlled trial that will test whether a personally tailored, distance-medicine-based program will increase exercise and fruit and vegetable consumption, and decrease fat intake of individuals recently diagnosed with breast or prostate cancer.
Methods:
Early-stage breast and prostate cancer cases (N= 530) will be identified within 9 months of diagnosis from hospital cancer registries and large oncologic practices throughout the United States. These individuals will be sent a letter of invitation and screened for eligibility. After a baseline telephone interview, participants will be randomized into one of two arms that receive materials aimed at increasing exercise and fruit and vegetable intake, and decreasing dietary fat: 1). an experimental arm that receives a workbook and a series of six 4-page newsletters delivered every 7 wk and personally tailored on type of cancer, cancer coping style, race, age, self-efficacy, stage of readiness, and barriers and/or progress toward goal behavior (i.e., >or= 30 min of exercise at least 5 d.wk, >or= 5 servings of vegetables and fruit per day, and
Conclusion:
Given the growing number of cancer survivors, distance-medicine-based interventions addressing multiple behaviors and targeting this high-risk group have the potential to make a positive and broad public health impact.
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