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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

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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

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

Source :

Contemporary clinical trials [ 1551-7144 ] ; 2014.

RBID : PMC:3992482

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 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27–45 kg/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 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information in how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3992482

DOI: 10.1016/j.cct.2014.01.010
PubMed: 24486636
PubMed Central: 3992482

Affiliations:

Le document en format XML

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<front><div type="abstract" xml:lang="en"><p id="P1">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 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27–45 kg/m<sup>2</sup>
, 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 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information in how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care.</p>
</div>
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<tree><noCountry><name sortKey="Befort, Christie A" sort="Befort, Christie A" uniqKey="Befort C" first="Christie A." last="Befort">Christie A. Befort</name>
<name sortKey="Diaz, Francisco J" sort="Diaz, Francisco J" uniqKey="Diaz F" first="Francisco J." last="Diaz">Francisco J. Diaz</name>
<name sortKey="Fabian, Carol" sort="Fabian, Carol" uniqKey="Fabian C" first="Carol" last="Fabian">Carol Fabian</name>
<name sortKey="Klemp, Jennifer R" sort="Klemp, Jennifer R" uniqKey="Klemp J" first="Jennifer R." last="Klemp">Jennifer R. Klemp</name>
<name sortKey="Perri, Michael G" sort="Perri, Michael G" uniqKey="Perri M" first="Michael G." last="Perri">Michael G. Perri</name>
<name sortKey="Schmitz, Kathryn H" sort="Schmitz, Kathryn H" uniqKey="Schmitz K" first="Kathryn H." last="Schmitz">Kathryn H. Schmitz</name>
<name sortKey="Shireman, Theresa" sort="Shireman, Theresa" uniqKey="Shireman T" first="Theresa" last="Shireman">Theresa Shireman</name>
<name sortKey="Sullivan, Debra K" sort="Sullivan, Debra K" uniqKey="Sullivan D" first="Debra K." last="Sullivan">Debra K. Sullivan</name>
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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

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

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