Weight Loss Program for Breast Cancer Survivors
Trial Summary
What is the purpose of this trial?
This clinical trial evaluates a remotely delivered, culturally tailored weight loss interventions in Latina breast cancer (BC) survivors. Cancer is the leading cause of death among Latinos, and among Latinas, BC is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer BC outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina BC survivors. The development of an adaptive program that provides survivors the support they need, as opposed to what is typically available, is essential to reducing persistent inequities in cancer survivorship.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, current endocrine therapy is allowed, so you may not need to stop all medications.
What data supports the effectiveness of the treatment Remotely Delivered, Culturally Tailored Weight Loss Interventions for breast cancer survivors?
Research shows that a group phone-based weight loss program for rural breast cancer survivors led to significant weight loss and improvements in diet and physical activity. Participants lost an average of 12.5 kg (about 13.9% of their starting weight) over six months, indicating the potential effectiveness of remotely delivered interventions.12345
Is the weight loss program safe for breast cancer survivors?
How is the Remotely Delivered, Culturally Tailored Weight Loss Interventions treatment unique for breast cancer survivors?
This treatment is unique because it is delivered remotely through group phone sessions, making it accessible for rural breast cancer survivors who may have limited access to in-person support. It combines a reduced-calorie diet with prepackaged meals, increased physical activity, and group support, which helps address both dietary and social support needs.23489
Research Team
Heather Greenlee
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
This trial is for Latina women who have survived breast cancer, are overweight with a BMI of 30 or higher, and are at least 60 days post-treatment. They must be fluent in Spanish or English, have no recurrent disease, and be able to use the internet and phone. Exclusions include insulin-dependent diabetics, those with major health issues preventing weight loss, active smokers, pregnant women or those planning pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline
Baseline
Participants receive written instructions and website link to an instructional video along with supportive materials including measuring tape, Aria WiFi-enabled scale, and Actigraph accelerometer to be worn for 7 days at baseline. Patients also undergo blood sample collection at baseline.
Stage I
Eligible participants are randomized to receive the online ¡Vida! program with health education sessions, dietary modifications, and home-based exercise sessions. Supportive materials include a Fitbit Aria scale, a Fitbit Luxe, the Fitbit app, and access to the Cook for Your Life website. Blood samples are collected.
Stage II
Participants achieving >= 2% weight loss continue their assigned interventions. Non-responders are re-randomized to receive additional interventions including lifestyle sessions, health coaching, and monthly groceries.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with body weight percent change assessed up to 12 months.
Treatment Details
Interventions
- Remotely Delivered, Culturally Tailored Weight Loss Interventions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator