An interventional study of Group phone counseling and Newsletter in Breast Cancer and Obesity, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to female participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-23.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
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.
Phase 1 - Weight Loss (0-6 months)
Phase 2 - Weight Loss Maintenance (6-18 months)
Phase 3 - Transition to Self-Reliance (18-24 months)
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 210 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
The 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.
Behavioral: Group phone counseling
Participants 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.
Behavioral: Newsletter
Bi-weekly phone counseling sessions from 6 - 18 months
Bi-weekly newsletter mailings from 6 - 18 months
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.
Time frame: 6 - 18 months
Quality of life
Compare the effects of treatment conditions on aspects of quality of life important for breast cancer survivorship, including general physical, social, and emotional well-being, fatigue, arthralgia, lymphedema symptoms, menopausal symptoms, and depressive symptoms.
Time frame: Baseline and 6, 12, 18, and 24 months
Breast cancer risk biomarkers
Examine the association of weight change with changes in selected breast cancer risk biomarkers, including bioavailable estradiol, testosterone, and fasting insulin. Examine whether modulation of biomarkers is sustained during weight loss maintenance.
Time frame: Baseline and 6 and 18 months
Cost effectiveness
Compare the incremental cost-effectiveness of weight loss maintenance (kg below baseline) between group and control conditions. Costs include fixed and variable provider costs (facility, time, phone charges, supplies) and fixed and variable participant costs (time, out-of-pocket expenses).
Time frame: 18 months
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center