Weight Loss Program for Breast Cancer Survivors

Overseen By Jenny Whitten-Brannon

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Must be taking: Endocrine therapy

Must not be taking: Insulin, Hypoglycemics

Disqualifiers: Active smoker, Major comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

640 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help Latina breast cancer survivors lose weight through online programs tailored to their community. The focus is on providing support not typically available, which could improve overall health and breast cancer recovery. Participants will engage with the ¡Vida! program, which includes online health education, dietary changes, and home exercise. Some will receive additional guidance through resources like health coaching. This trial suits Latina breast cancer survivors diagnosed within the last five years, with a BMI of 27 or greater, and internet access for online sessions. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance recovery and health outcomes for Latina breast cancer survivors.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, current endocrine therapy is allowed, so you may not need to stop all medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that weight loss programs designed for breast cancer survivors, delivered remotely and tailored to cultural needs, are generally safe. Studies on similar programs have found that participants can lose weight effectively without major side effects. For instance, breast cancer patients in a similar program lost about 4.7% of their starting weight, indicating the program is well-tolerated.

These programs typically include online health education, dietary changes, and home-based exercises, which are common and generally safe ways to manage weight. Participants also use tools like fitness trackers, known to be safe for most people. While each program may differ, the components used here have a strong safety record in other settings.

This trial is in the "Not Applicable" phase, indicating it is early in testing. The focus is on understanding its effectiveness and safety. However, since the program uses well-established methods, it is expected to be safe for most participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these weight loss interventions for breast cancer survivors because they offer a tailored, remote approach that integrates cultural sensitivity, which is not typically emphasized in standard weight loss programs. The interventions use the ¡Vida! program, which includes 24 online health sessions, dietary changes, and home-based exercises. Participants receive support through devices like Fitbits and access to resources like the Cook for Your Life website. Additionally, some program variations include Experiential Learning sessions, individualized health coaching, and mailed toolkits, offering a comprehensive and adaptable approach to weight management that goes beyond traditional methods. These features could lead to more effective and sustainable weight loss outcomes by addressing the unique needs of breast cancer survivors.

What evidence suggests that this trial's treatments could be effective for weight loss in Latina breast cancer survivors?

Research has shown that weight loss programs delivered remotely and tailored to cultural needs can benefit breast cancer survivors. This trial will enroll participants in different arms to test the effectiveness of various interventions. One study showed that participants in a similar program lost an average of 4.7% of their body weight after one year. This is important because being overweight can lead to worse outcomes for breast cancer patients. Early results suggest that focusing on diet, exercise, and cultural preferences can help achieve these results. Although no specific programs exist for Latina breast cancer survivors yet, these tailored programs seem promising in filling this gap. ^{1 2 3 6 7}

Who Is on the Research Team?

Heather Greenlee

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for Latina women who have survived breast cancer, are overweight with a BMI of 30 or higher, and are at least 60 days post-treatment. They must be fluent in Spanish or English, have no recurrent disease, and be able to use the internet and phone. Exclusions include insulin-dependent diabetics, those with major health issues preventing weight loss, active smokers, pregnant women or those planning pregnancy.

Inclusion Criteria

Access to internet and smartphone, tablet, or computer to participate in the online program and to be able to sync study WiFi devices

You live in an area where the online grocery delivery service can deliver your groceries.

I was diagnosed with stage I-III breast cancer in the last 5 years.

Exclusion Criteria

I am diabetic and use insulin or other medications to lower my blood sugar.

You have significant health problems or physical limitations that would make it hard for you to lose weight or be physically active.

I am using hormones for gender transition.

Timeline for a Trial Participant

Baseline

Participants receive written instructions and website link to an instructional video along with supportive materials including measuring tape, Aria WiFi-enabled scale, and Actigraph accelerometer to be worn for 7 days at baseline. Patients also undergo blood sample collection at baseline.

1 week

1 visit (remote)

Stage I

Eligible participants are randomized to receive the online ¡Vida! program with health education sessions, dietary modifications, and home-based exercise sessions. Supportive materials include a Fitbit Aria scale, a Fitbit Luxe, the Fitbit app, and access to the Cook for Your Life website. Blood samples are collected.

26 weeks

Multiple sessions (remote)

Stage II

Participants achieving >= 2% weight loss continue their assigned interventions. Non-responders are re-randomized to receive additional interventions including lifestyle sessions, health coaching, and monthly groceries.

Up to 12 months

Multiple sessions (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with body weight percent change assessed up to 12 months.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remotely Delivered, Culturally Tailored Weight Loss Interventions

Trial Overview The study tests a weight loss program tailored for Latina breast cancer survivors that includes lifestyle counseling, exercise programs, nutritional advice and more—all delivered remotely via phone or internet. The goal is to see if this support can help them lose weight effectively.

How Is the Trial Designed?

Group I: Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits Experimental Treatment 4 Interventions

Participants participate in the online ¡Vida! program consisting of 24 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria 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 receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also 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. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were non-responders (\<2% weight loss at 8 weeks). In Stage 2, non-responders receive additional ¡Vida! Plus intervention programming, and also receive health coaching (HC) as well as mailed toolkits (MT).

Group II: Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC) Experimental Treatment 3 Interventions

Participants participate in the online ¡Vida! program consisting of 24 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria 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 receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were non-responders (\<2% weight loss at 8 weeks). In Stage 2, non-responders receive additional ¡Vida! Plus intervention programming, and also receive health coaching.

Group III: Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus Experimental Treatment 2 Interventions

Participants participate in the online ¡Vida! program consisting of 24 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria 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 receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were responders (≥2% weight loss at 8 weeks). In Stage 2, responders receive additional ¡Vida! Plus intervention programming.

Group IV: Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC) Experimental Treatment 3 Interventions

Participants participate in the online ¡Vida! program consisting of 24 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria 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 receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (\<2% weight loss at 8 weeks). In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL), and also receive health coaching.

Group V: Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus Experimental Treatment 2 Interventions

Participants participate in the online ¡Vida! program consisting of 24 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria 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 receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (\<2% weight loss at 8 weeks). In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL).

Group VI: Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida! Experimental Treatment 1 Intervention

Participants participate in the online ¡Vida! program consisting of 24 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Fitbit Aria 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. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were responders (≥2% weight loss at 8 weeks). In Stage 2, responders receive additional ¡Vida! intervention programming.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A telephone-delivered weight loss intervention for women with a BMI of 25-40 kg/m2 after breast cancer treatment resulted in a significant average weight loss of 3.1 kg compared to usual care, demonstrating its efficacy.

The intervention was found to be feasible and acceptable, with high participant satisfaction, and only one reported adverse event, indicating it is a safe option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. Reeves, M., Winkler, E., Mccarthy, N., et al.[2022]

A group-based weight control intervention delivered via conference calls led to an average weight loss of 12.5 kg (13.9% of baseline weight) among obese breast cancer survivors in rural areas, demonstrating its efficacy in this population.

Participants also showed significant improvements in waist circumference, dietary habits, physical activity levels, and quality of life, including mood and body image, indicating that the intervention positively impacted both health and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a weight loss intervention among rural breast cancer survivors. Befort, CA., Klemp, JR., Austin, HL., et al.[2021]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03748

Remotely Delivered, Culturally Tailored Weight Loss ... This clinical trial evaluates a remotely delivered, culturally tailored weight loss interventions in Latina breast cancer (BC) survivors.

2. reporter.nih.gov reporter.nih.gov/search/bCJpoAhZoE2AAlcrv59AEA/project-details/10873685

Using a SMART design to evaluate remotely delivered, culturally ... We have developed and tested multi-component weight loss, dietary change, and physical activity (PA) interventions among BC survivors, with a focus on ...

3. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/P3-08-23/754060/Abstract-P3-08-23-Using-a-SMART-Approach-to?searchresult=1

Abstract P3-08-23: Using a SMART Approach to Culturally-Adapt ... An estimated 80% of US Latina women have overweight or obesity, which is a major contributor to BC incidence and recurrence. Culturally tailored, effective, and ...

4. dana-farber.org dana-farber.org/newsroom/news-releases/2025/weight-loss-trial-reports-success-for-breast-cancer-patients-at-one-year-mark

Weight Loss Trial Reports Success for Breast Cancer ... Breast cancer patients who participated in a remote weight loss intervention program lost an average of 4.7 percent of their baseline body ...

5. paperdigest.org paperdigest.org/grant/?grant_id=nih_10587753

Grant: ""Using A SMART Design to Evaluate Remotely Delivered ... Using A SMART Design to Evaluate Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors". NIH Grant: $0.75M.

6. withpower.com withpower.com/trial/phase-breast-neoplasms-10-2023-28fcf

Weight Loss Program for Breast Cancer Survivors This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second ...

7. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=11081301&term=CA270441

Division of Cancer Control & Population Sciences - Grant Details Using a Smart Design to Evaluate Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors. Fiscal Year: 2024 ...