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

Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 7 days
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "BASELINE: Participants receive written instructions and website link to complete surveys along with supportive materials including a measuring tape, 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The ¡Vida! trial tests weight loss programs delivered from a distance and designed for Latina breast cancer survivors. It is for adults who had stage I–III breast cancer and have a body mass index (BMI) of 27 or higher.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female biological sex, age 18 or older, and identify as Hispanic or Latina.
  • Able to read and write in Spanish, English, or both.
  • Diagnosed with stage I–III breast cancer within the past 5 years, with no signs of cancer now, cancer that has returned, or cancer that has spread.
  • At least 60 days past chemotherapy, radiation, and cancer-related surgery. Certain hormone, targeted, and antibody treatments are allowed, as is breast reconstruction.
  • BMI of 27 or higher. BMI is a measure based on height and weight; the study will check it before assigning a study group.
  • Fully active or able to walk and do light work, even if hard physical activity is limited (ECOG score 0 or 1).
  • Willing to do all study activities and complete the starting health checks at home before being assigned a study group.
  • Have a phone and internet access for study contacts, the online program, and connecting study devices.

Who can't join

  • BMI below 27 at the starting health checks.
  • Diabetes treated with insulin or sulfonylurea drugs, or use of GLP-1 drugs at the start of the study. Metformin is allowed.
  • Currently taking cell-killing chemotherapy, such as capecitabine, or antibody-linked cancer drugs, such as T-DM1 or T-DXd.
  • Major health problems or physical limits that prevent safe weight loss, eating less, or physical activity.
  • Pregnant, breastfeeding, planning pregnancy during the study, or using hormones for gender affirmation.
  • Expecting major surgery within 3 months after joining. Breast reconstruction is allowed.
  • Taking part in another weight loss or physical activity trial.
  • For stool samples only: antibiotics, antifungal drugs, or anti-parasite drugs taken by mouth or vein in the past 6 months; a surgical opening for stool to leave the body (ileostomy or colostomy); or bowel inflammation diseases such as Crohn’s disease or ulcerative colitis.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months * 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 sites (1)

WA