Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study
Fred Hutchinson Cancer Center
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.
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, part…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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, pembrolizuma…
Interventions
- Behavioral¡Vida! program
Participate in ¡Vida! program
- Behavioral¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
Participate in ¡Vida! Plus program
- BehavioralHealth Coaching
Receive health coaching
- BehavioralMailed Toolkits
Receive a mailed toolkit of health items
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington