Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05930483

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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