RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors

Quick Facts

Study Start:2025-04-08
Study Completion:2028-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05930483

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biologically female
  2. * Age \>= 18 years
  3. * Self-identifies Hispanic/Latina
  4. * Fluent in Spanish and/or English
  5. * Previously diagnosis of stage I-III BC within the past 5 years
  6. * No evidence of current, recurrent, or metastatic disease
  7. * \> 60 days post treatment (current endocrine therapy allowed)
  8. * 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
  9. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  10. * Willingness to participate in all study activities
  11. * Access to phone for study contacts
  12. * Access to internet and smartphone, tablet, or computer to participate in the online program and to be able to sync study WiFi devices
  13. * Access to internet to participate in the online program and to be able to sync study devices
  14. * Successful completion of at-home baseline assessments prior to randomization
  1. * Body mass index (BMI) \< 27 kg/m\^2
  2. * Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)
  3. * Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA
  4. * Pregnant, breastfeeding, or planning to become pregnant during the study period
  5. * Use of exogenous hormones for gender affirmation

Contacts and Locations

Study Contact

Jenny Whitten-Brannon
CONTACT
206-667-5625
jwhitten@fredhutch.org

Principal Investigator

Heather Greenlee
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Fred Hutchinson Cancer Center

  • Heather Greenlee, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-08
Study Completion Date2028-03-01

Study Record Updates

Study Start Date2025-04-08
Study Completion Date2028-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8