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

ConditionsAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biologically female

Age >= 18 years

Self-identifies Hispanic/Latina

Able to read and write in Spanish and/or English

Disqualifiers

Body mass index (BMI) < 27 kg/m² 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])

Trial design

Design model

Sequential

Treatments tested in this trial

  • ¡Vida! program

    Behavioral

    Participate in ¡Vida! program

  • ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]

    Behavioral

    Participate in ¡Vida! Plus program

  • Health Coaching

    Behavioral

    Receive health coaching

  • Mailed Toolkits

    Behavioral

    Receive a mailed toolkit of health items

Treatment groups

640 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida!Experimental treatment 1 intervention
Group B: Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! PlusExperimental treatment 2 interventions
Group C: Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC)Experimental treatment 3 interventions
Group D: Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! PlusExperimental treatment 2 interventions
Group E: Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC)Experimental treatment 3 interventions
Group F: Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed ToolkitsExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Body weight (kg) percent change

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.

Time frame
Baseline to 12 months

Secondary outcomes

1

Body weight (kg) percent change as moderated by baseline characteristics

Will be determined by whether EAI effectiveness is moderated by baseline patient characteristics.

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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