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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

Identifieur interne : 001849 ( Pmc/Checkpoint ); précédent : 001848; suivant : 001850

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 :

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


Affiliations:


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PMC:3992482

Le document en format XML

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<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>
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<surname>Befort</surname>
<given-names>Christie A.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="A1">a</xref>
<xref ref-type="corresp" rid="CR1">*</xref>
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<given-names>Jennifer R.</given-names>
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<degrees>PhD</degrees>
<xref ref-type="aff" rid="A1">a</xref>
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<name>
<surname>Fabian</surname>
<given-names>Carol</given-names>
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<degrees>MD</degrees>
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<given-names>Michael G.</given-names>
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<degrees>PhD</degrees>
<xref ref-type="aff" rid="A2">b</xref>
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<given-names>Debra K.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="A1">a</xref>
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<name>
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University of Kansas Medical Center 3901 Rainbow Blvd, Kansas City, KS, USA
<email>jklemp@kumc.edu</email>
;
<email>cfabian@kumc.edu</email>
;
<email>dsulliva@kumc.edu</email>
;
<email>tshirema@kumc.edu</email>
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<label>b</label>
University of Florida PO Box 100185, Gainesville, FL 32610
<email>mperri@phhp.ufl.edu</email>
</aff>
<aff id="A3">
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University of Pennsylvania, Perelman School of Medicine 423 Guardian Drive, Philadelphia, PA 19104
<email>schmitz@mail.med.upenn.edu</email>
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<author-notes>
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Corresponding author
<email>cbefort@kumc.edu</email>
, 913 588-3338;</corresp>
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<day>18</day>
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<day>01</day>
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<year>2015</year>
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<issue>2</issue>
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<copyright-statement>© 2014 Elsevier Inc. All rights reserved</copyright-statement>
<copyright-year>2014</copyright-year>
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<abstract>
<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>
</abstract>
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