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Behavioral Intervention

Weight Loss Program for Breast Cancer Survivors

N/A

Waitlist Available

Led By Heather Greenlee

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biologically female

> 60 days post treatment (current endocrine therapy allowed)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial will evaluate a tailored weight loss program for Latina breast cancer survivors to combat the leading cause of death among Latinos.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not drug-related interventions that typically cause side effects like medications do; participants may experience discomfort from lifestyle changes such as muscle soreness from new exercises or challenges adjusting to dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am biologically female.

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I finished my last cancer treatment over 60 days ago, but I may still be on hormone therapy.

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My cancer has not returned or spread to other parts of my body.

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I am 18 years old or older.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body weight (kg) percent change

Secondary outcome measures

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food))Experimental Treatment13 Interventions

Participants participate in the online ¡Vida! program consisting of 26 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 Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions and receive a bag of groceries each month on study. Patients also undergo blood sample collection on study.

Group II: Stage II, Arm V (¡Vida!, lifestyle sessions, coaching)Experimental Treatment12 Interventions

Participants receive interventions as in arm IV.

Group III: Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching)Experimental Treatment12 Interventions

Participants participate in the online ¡Vida! program consisting of 26 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 Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions and receive 14 30-minute individualized telephone health coaching sessions. Patients also undergo blood sample collection on study.

Group IV: Stage II, Arm III (¡Vida!, lifestyle sessions)Experimental Treatment11 Interventions

Participants receive interventions as in arm II.

Group V: Stage I, Arm II (¡Vida!, lifestyle sessions)Experimental Treatment11 Interventions

Participants participate in the online ¡Vida! program consisting of 26 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 Luxe (or latest device), the Fitbit app, and access to the Cook for Your Life website on study. Participants also attend remote lifestyle health education sessions on study. Patients also undergo blood sample collection on study.

Group VI: Stage I, Arm I (¡Vida!)Experimental Treatment10 Interventions

Group VII: Baseline (instructions, video, tape, scale, accelerometer)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telephone-Based Intervention

2017

Completed Phase 2

~3400

Behavioral Dietary Intervention

2016

N/A

~70

Biospecimen Collection

2004

Completed Phase 2

~1730

Behavioral Intervention

2021

Completed Phase 4

~3740

Lifestyle Counseling

2011

Completed Phase 2

~7440

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,342,648 Total Patients Enrolled

18 Trials studying Breast Cancer

21,498 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,533 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Heather GreenleePrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

3 Previous Clinical Trials

170 Total Patients Enrolled

Media Library

Remotely Delivered, Culturally Tailored Weight Loss Interventions (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05930483 — N/A

Breast Cancer Research Study Groups: Stage I, Arm I (¡Vida!), Baseline (instructions, video, tape, scale, accelerometer), Stage II, Arm V (¡Vida!, lifestyle sessions, coaching), Stage II, Arm VI (¡Vida!, lifestyle sessions, coaching, food)), Stage II, Arm IV (¡Vida!, lifestyle sessions, coaching), Stage I, Arm II (¡Vida!, lifestyle sessions), Stage II, Arm III (¡Vida!, lifestyle sessions)

Remotely Delivered, Culturally Tailored Weight Loss Interventions (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05930483 — N/A

Breast Cancer Clinical Trial 2023: Remotely Delivered, Culturally Tailored Weight Loss Interventions Highlights & Side Effects. Trial Name: NCT05930483 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still underway for this experiment?

"According to the info on clinicaltrials.gov, this investigation is not currently recruiting participants; however, it was originally posted in November 1st 2023 and last updated June 26th 2023. Despite its closure for recruitment, there are still 2,567 studies that accept patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors

2024. "Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05930483.