NCT01441011

Rural Women Connecting for Better Health

Group Phone-Based Weight Control for Rural Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase 1 - Weight Loss (0-6 months) * Weekly group phone counseling sessions for all participants (12-14 women per group) via conference call for 26 consecutive weeks * Low-calorie, low-fat diet recommended, including 2 pre-packaged entrees, five one-cup servings of fruits and vegetables and meal replacement shakes (provided free of charge) * Physical activity program program recommended, beginning with 15 minutes per day, 3 days a week, working toward a goal of 225 minutes a week * Experienced group counselor facilitates all sessions Phase 2 - Weight Loss Maintenance (6-18 months) * Participants randomized to either group phone counseling or mail-based comparison with no phone counseling * Weight loss maintenance group condition includes 26 bi-weekly phone sessions, while mail-based comparison includes 26 bi-weekly newsletters in the mail * Focus is on problem-solving Phase 3 - Transition to Self-Reliance (18-24 months) * Lasts from 18-24 months * No sessions or newsletter mailings * Participants are encouraged to continue to self-monitor throughout this period

Conditions

• Breast Cancer
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Group phone counseling	Bi-weekly phone counseling sessions from 6 - 18 months
BEHAVIORAL	Newsletter	Bi-weekly newsletter mailings from 6 - 18 months

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-04-01
• Completion: 2015-10-01
• First posted: 2011-09-27
• Last updated: 2016-11-23

Locations

1 site across 1 country: United States