Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
This clinical trial evaluates a remotely delivered, community aligned weight loss interventions in Latina breast cancer (BC) survivors. Cancer is the leading cause of death among Latinos, and among Latinas, BC is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer BC outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina BC survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, is essential to reducing persistent inequities in cancer survivorship.
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: 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05930483.
Locations matching your search criteria
United States
Washington
Seattle
PRIMARY OBJECTIVE:
I. To compare the effectiveness of adaptive interventions for weight loss in Latina BC survivors, beginning with ¡Vida! or ¡Vida! + experiential learning (EL) (stage 1) and augmented behavioral support for 11 months for non-responders (stage 2).
SECONDARY OBJECTIVE:
I. To use a novel data-driven approach to determine whether key individual baseline characteristics moderate the effect of the adaptive interventions on weight loss, and thus lay the groundwork for more personalized adaptive weight loss strategies.
EXPLORATORY OBJECTIVES:
I. Assess whether intervention engagement moderates the effect of the adaptive interventions on weight loss.
II. Compare the effects of adaptive interventions on changes in inflammatory and cardiometabolic biomarkers, diet quality, and physical activity (PA).
III. Quantitatively assess biopsychosocial predictors/mediators of behavior change.
IV. Qualitatively assess the participant experience to understand factors that contribute to study outcomes.
OUTLINE: This study includes a baseline run-in and randomized stage I and stage II studies.
BASELINE: Participants receive written instructions and website link to an instructional video along with supportive materials including 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 I: Eligible participants from the baseline run-in are randomized to arm I or II.
ARM I: Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also undergo blood sample collection on study.
ARM II: Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions on study. Participants also undergo blood sample collection on study.
STAGE II: Participants who achieve >= 2% weight loss (responders) at 2 months continue their assigned interventions in stage I. Participants who achieve < 2% weight loss (non-responders) at 2 months are re-randomized to 1 of 4 arms. Participants who were assigned to arm I in stage I are randomized to arm III or IV. Participants who were assigned to arm II in stage I are randomized to arms V or VI.
ARM III: Participants receive interventions as in arm II.
ARM IV: Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study.
ARM V: Participants receive interventions as in arm IV.
ARM VI: Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 9 30-minute individualized telephone health coaching sessions and receive a mailed toolkit of health items twice on study. Participants also undergo blood sample collection on study.
Trial PhasePhase II
Trial Typeprevention
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorHeather Greenlee
- Primary IDRG1123416
- Secondary IDsNCI-2023-03748
- ClinicalTrials.gov IDNCT05930483