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.
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(2), 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 on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care.
University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, USA. Electronic address: cbefort@kumc.edu.
Christie A
CA
Befort
University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, USA. Electronic address: jklemp@kumc.edu.
Jennifer R
JR
Klemp
University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, USA. Electronic address: cfabian@kumc.edu.
Carol
C
Fabian
University of Florida, PO Box 100185, Gainesville, FL 32610, USA. Electronic address: mperri@phhp.ufl.edu.
Michael G
MG
Perri
University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, USA. Electronic address: dsulliva@kumc.edu.
Debra K
DK
Sullivan
University of Pennsylvania, Perelman School of Medicine, 423 Guardian Drive, Philadelphia, PA 19104, USA. Electronic address: schmitz@mail.med.upenn.edu.
Kathryn H
KH
Schmitz
University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, USA.
Francisco J
FJ
Diaz
University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, USA. Electronic address: tshirema@kumc.edu.
Theresa
T
Shireman
D000368:Aged; D015992:Body Mass Index; D001837:Body Weights and Measures; D001943:Breast Neoplasms / Q000453:epidemiology*; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics / Q000379:methods*; D004032:Diet; D015444:Exercise; D005260:Female; D006801:Humans; D007398:Interpersonal Relations; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology* / Q000523:psychology / Q000628:therapy*; D018579:Patient Selection; D011788:Quality of Life; D012107:Research Design; D012424:Rural Population; D012657:Self-Help Groups; D012959:Socioeconomic Factors; D017741:Survivors; D013689:Telephone; D015431:Weight Loss
Behavioral weight control; Breast cancer; Obesity; Quality of life; Rural