Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial

Not Applicable

Recruiting

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8

• Registration Number: NCT05930483
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

Detailed Description

OUTLINE: This sequential multiple assignment randomized trial (SMART) will test four different community-aligned 12-month adaptive weight loss interventions.

BASELINE: Participants receive written instructions and website link to complete surveys along with supportive materials including a measuring tape, Aria Bluetooth-enabled scale, and may receive an Actigraph accelerometer to be worn for 7 days at baseline. Participants also undergo blood sample collection at baseline.

STAGE ONE: Eligible participants from the baseline run-in are randomized to participate in Stage One. In Stage One, participants are randomized to one of two groups: ¡Vida! or ¡Vida! Plus.

STAGE TWO: Percent weight loss is measured at week 8. Women who lose ≥2% of their body weight at week 8 will be considered "Responders" and will continue with their original randomization assignment in Stage Two.

Women in the Stage One ¡Vida! group who lose \<2% of their body weight will be re-randomized in Stage Two to receive either ¡Vida! Plus or ¡Vida! Plus + health coaching (HC). Women in the Stage One ¡Vida! Plus group who lose \<2% of their body weight will be re-randomized in Stage Two to receive either ¡Vida! Plus + HC or ¡Vida! Plus + HC + mailed toolkits (MT).

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-05
• Study Start: 2025-04-08
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-20
• Primary Completion: 2028-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 640

Inclusion Criteria

• Biologically female
• Age >= 18 years
• Self-identifies Hispanic/Latina
• Fluent in Spanish and/or English
• Previously diagnosis of stage I-III BC within the past 5 years
• No evidence of current, recurrent, or metastatic disease
• > 60 days post treatment (current endocrine therapy allowed)
• 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 and smartphone, tablet, or computer to participate in the online program and to be able to sync study WiFi devices
• 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
• Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Body weight (kg) percent change	Baseline to 12 months	Will be assessed by the percent of weight loss at month 12 and compared across the four embedded adaptive intervention (EAI) groups using the doubly robust estimator model.

Secondary Outcome Measures

Name	Time	Method
Body weight (kg) percent change as moderated by baseline characteristics	Baseline to 12 months	Will be determined by whether EAI effectiveness is moderated by baseline patient characteristics.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States