Anatomic Stage I Breast Cancer AJCC v8 study: Health Coaching vs Mailed Toolkits
Official title Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
ClinicalTrials.gov ID: NCT05930483
What this study is testing
- What it's testing
- The study wants to see if this program can help Latina survivors lose weight and improve their overall health after breast cancer.
- Who it's for
- It is looking for Latina women who have had stage I, II, or III breast cancer.
- What's involved
- Participants will receive a weight‑loss program delivered remotely, with support that fits their community and lifestyle, including diet and exercise guidance.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.