Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial (NCT05930483)
Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (13 items).
Location: Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington
Age range: 18 Years
🧪 Interventions in This Study
- ¡Vida! program (BEHAVIORAL)
- ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] (BEHAVIORAL)
- Health Coaching (BEHAVIORAL)
- Mailed Toolkits (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Body mass index (BMI) \< 27 kg/m\^2 at time of baseline data collection
- Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)
- Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline
- Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine \[T-DM1\], trastuzumab deruxtecan \[T-DXd\])
- Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA
- Pregnant, breastfeeding, or planning to become pregnant during the study period
- Use of exogenous hormones for gender affirmation
- For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months
- For stool sample collection only: Presence of self-reported ileostomy or colostomy
- For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)
- Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (206) 667-5625
Email: jwhitten@fredhutch.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.