Weight loss program for Latina breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.