Rural Women Connecting for Better Health
Group Phone-Based Weight Control for Rural Breast Cancer Survivors
2 other identifiers
interventional
210
1 country
1
Brief Summary
Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death. Rural women suffer from health disparities in breast cancer diagnosis and treatment. Women of the most rural counties also have the highest prevalence of obesity compared to urban women. To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors. Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women. This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity. However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence. This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions. In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions and the impact on secondary outcomes including quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Aug 2011
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
September 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 23, 2016
November 1, 2016
3.7 years
September 23, 2011
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss maintenance
Examine the impact of group phone-based treatment on weight loss maintenance from 6 to 18 months, compared to a mail-based education COMPARISON condition, following a 6-month weight loss phase among obese rural breast cancer survivors.
6 - 18 months
Secondary Outcomes (3)
Quality of life
Baseline and 6, 12, 18, and 24 months
Breast cancer risk biomarkers
Baseline and 6 and 18 months
Cost effectiveness
18 months
Study Arms (2)
Group (GRP) phone counseling
EXPERIMENTALThe group phone counseling includes 26 bi-weekly phone sessions from 6 to 18 months and focuses on group problem-solving. Women continue in the same group as in weight loss intervention phase.
Mail-based Comparison Condition
ACTIVE COMPARATORParticipants in this group will receive a newsletter by mail every other week for 12 months starting after the initial 6 month weight loss period. The newsletters will provide problem-solving tips and will review nutrition and physical activity information.
Interventions
Bi-weekly phone counseling sessions from 6 - 18 months
Eligibility Criteria
You may qualify if:
- Breast cancer patients with a BMI 27-45 kg/m2
- Diagnosis of Stage 0-IIIc disease within the past 10 years (except Stage 0, treated with mastectomy only)
- Have completed all local and systemic therapy at least 3 months prior to entry
- Have clearance from their oncologist or current medical provider to participate in a weight control study
- Must be ≤ 75 years old
- Post-menopausal
- Participants must live in a rural area
- Have access to a phone
- Able to participate in the physical activity component of the intervention, i.e., be able to walk briskly unassisted and without serious medical risk
- Weight stable within ten pounds three months prior to entry
You may not qualify if:
- Women with insulin-dependent diabetes
- Ongoing participation in a formal weight loss program
- Ongoing use of pharmacotherapy for weight loss
- Ongoing use of medications that seriously affect weight and metabolism (e.g., steroids, phentermine)
- Positive screen for current substance abuse, major depression, or binge eating disorder
- Any cardiac or pulmonary disease preventing participation
- Treatment for any other cancers within the past year
- Previous bariatric surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (4)
Fazzino TL, Fabian C, Befort CA. Change in Physical Activity During a Weight Management Intervention for Breast Cancer Survivors: Association with Weight Outcomes. Obesity (Silver Spring). 2017 Nov;25 Suppl 2(Suppl 2):S109-S115. doi: 10.1002/oby.22007.
PMID: 29086523DERIVEDFazzino TL, Fleming K, Befort C. Alcohol Intake Among Breast Cancer Survivors: Change in Alcohol Use During a Weight Management Intervention. JMIR Cancer. 2016 Nov 9;2(2):e15. doi: 10.2196/cancer.6295.
PMID: 28410181DERIVEDFazzino TL, Sporn NJ, Befort CA. A qualitative evaluation of a group phone-based weight loss intervention for rural breast cancer survivors: Themes and mechanisms of success. Support Care Cancer. 2016 Jul;24(7):3165-73. doi: 10.1007/s00520-016-3149-7. Epub 2016 Mar 2.
PMID: 26932848DERIVEDBefort CA, Klemp JR, Fabian C, Perri MG, Sullivan DK, Schmitz KH, Diaz FJ, Shireman T. 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. Contemp Clin Trials. 2014 Mar;37(2):261-71. doi: 10.1016/j.cct.2014.01.010. Epub 2014 Jan 31.
PMID: 24486636DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christie Befort, Ph.D.
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2011
First Posted
September 27, 2011
Study Start
August 1, 2011
Primary Completion
April 1, 2015
Study Completion
October 1, 2015
Last Updated
November 23, 2016
Record last verified: 2016-11