Actively Recruiting
Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
Led by Fred Hutchinson Cancer Center · Updated on 2025-12-11
640
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.
CONDITIONS
Official Title
Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biologically female
- Age 18 years or older
- Self-identifies as Hispanic or Latina
- Able to read and write in Spanish and/or English
- Previous diagnosis of stage I, II, or III breast cancer within the past 5 years
- No evidence of current, recurrent, or metastatic disease
- At least 60 days past treatment including chemotherapy, radiation, and cancer-related surgery
- Current allowed therapies include endocrine therapy, CDK4/6 inhibitors, HER2-directed therapies, and monoclonal antibodies
- Surgery for breast reconstruction allowed during the trial
- Body mass index (BMI) 27 kg/m² or higher confirmed by measurement
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Willingness to participate in all study activities
- Access to a phone for study contacts
- Access to internet to join the online program and sync study devices
- Successful completion of at-home baseline assessments before randomization
You will not qualify if you...
- Body mass index (BMI) less than 27 kg/m² at baseline
- Diabetes treated with insulin or sulfonylurea medications
- Use of glucagon-like peptide-1 receptor agonists at baseline
- Current use of cytotoxic chemotherapy or drug-antibody conjugates
- Major health conditions or physical limitations preventing healthy weight loss or physical activity
- Pregnant, breastfeeding, or planning pregnancy during the study
- Use of exogenous hormones for gender affirmation
- Recent use of oral or intravenous antibiotics, antifungals, or anti-parasitics in past 6 months (for stool sample collection)
- Presence of ileostomy or colostomy (for stool sample collection)
- Presence of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis (for stool sample collection)
- Planned major surgery within 3 months after registration (breast reconstruction allowed)
- Concurrent participation in another weight loss or physical activity trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
J
Jenny Whitten-Brannon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
6
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