Weight loss program for Latina breast cancer survivors
Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study
This study tests a weight loss program designed for Latina breast cancer survivors to see if it helps them lose weight and improve their health through online education and support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 640 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fred Hutchinson Cancer Center Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, pembrolizumab, neratinib, chemotherapy, radiation |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05930483 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a remotely delivered, culturally tailored weight loss intervention specifically designed for Latina breast cancer survivors. The program includes an initial baseline assessment followed by a randomized phase where participants are assigned to one of two arms, both involving online health education sessions, dietary modifications, and exercise. Participants receive various supportive materials, including fitness tracking devices and access to educational resources. The goal is to promote effective weight loss and improve health outcomes among this population, addressing significant health disparities.
Who should consider this trial
Good fit: Ideal candidates for this study are biologically female, Hispanic/Latina breast cancer survivors aged 18 and older with a BMI of 30 kg/m² or higher.
Not a fit: Patients who are not fluent in Spanish or English, or those with recurrent or metastatic breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved health outcomes and quality of life for Latina breast cancer survivors by promoting effective weight loss.
How similar studies have performed: Other studies have shown success with culturally tailored interventions for minority populations, suggesting potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biologically female * Age \>= 18 years * Self-identifies Hispanic/Latina * Able to read and write in Spanish and/or English * Previous diagnosis of stage I-III BC within the past 5 years * No evidence of current, recurrent, or metastatic disease * 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4/6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial) * Body mass index (BMI) \>= 27 kg/m\^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Willingness to participate in all study activities * Access to phone for study contacts * Access to internet to participate in the online program and to be able to sync study devices * Successful completion of at-home baseline assessments prior to randomization 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. * Concurrent enrollment in another weight loss or physical activity trial
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Heather Greenlee — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Jenny Whitten-Brannon
- Email: jwhitten@fredhutch.org
- Phone: 206-667-5625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.