Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors

Christie A. Befort, Jennifer R. Klemp, Carol Fabian, Michael G. Perri, Debra K. Sullivan, Kathryn H. Schmitz, Francisco J. Diaz, Theresa Shireman

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n=210) diagnosed with Stage 0 to III breast cancer in the past 10years who are ≥3months out from initial cancer treatments, have a BMI 27-45kg/m2, and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care.

Original languageEnglish (US)
Pages (from-to)261-271
Number of pages11
JournalContemporary Clinical Trials
Volume37
Issue number2
DOIs
StatePublished - Mar 2014

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

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