Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)

July 14, 2026 updated by: M.D. Anderson Cancer Center

The goal of this research study is to learn about the effects of the BBCSI course on the quality of life of Black breast cancer survivors.

A community-based and peer-led Black Breast Cancer Survivor's Intervention (BBCSI) course has been developed to help improve the quality of life of Black breast cancer survivors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives:

Develop a prototype of the BBCSI curriculum and assess satisfaction of the intervention.

Determine the preliminary efficacy of the BBCSI.

Evaluate fidelity, feasibility, acceptability, barriers, and facilitators of the BBCSI.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M. D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Community Based Organizations

Description

Inclusion Criteria:

Master Trainers:

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. Adult women aged 18 years and older
  2. Histologically confirmed stage 0-III breast cancer
  3. No evidence of metastatic disease
  4. Self-identify as Black
  5. Able to communicate in English

Participants:

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. Adult women aged 18 years and older
  2. Histologically confirmed stage 0-III breast cancer
  3. No evidence of metastatic disease
  4. Within four-years of diagnosis
  5. Self-identify as Black
  6. Able to communicate in English

Community Interventionists:

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. Adult women aged 18 years and older
  2. Histologically confirmed stage 0-III breast cancer
  3. No evidence of metastatic disease
  4. Self-identify as Black
  5. Former study participants that have completed the intervention
  6. Able to communicate in English

General Exclusion Criteria:

  1. Men or woman below 18 years of age
  2. Does not have a histologically confirmed breast cancer
  3. There's evidence of metastatic disease
  4. Does not self-identify as Black
  5. Unable to communicate in English

Additional Exclusion Criteria - Participants 1. More than four years of diagnosis

Additional Exclusion Criteria - Community Interventionists

1. Has not previously participated in and completed the study intervention as a participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Intervention Group
Participants will be recruited through our Community Based Organizations (CBOs) and other community collaborator networks.
Behavioral: Black Breast Cancer Survivor's Intervention
Participants will complete the BBCSI course (1-hour virtual sessions every week for 6 weeks), answer questionnaires before and after the course, and provide urine samples.
Experimental: Wait-List (start in week 7)
Participants will be recruited through our Community Based Organizations (CBOs) and other community collaborator networks.
Behavioral: Black Breast Cancer Survivor's Intervention
Participants will complete the BBCSI course (1-hour virtual sessions every week for 6 weeks), answer questionnaires before and after the course, and provide urine samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Adverse Events (AEs)
Time Frame: Time Frame: Through study completion; an average of 1 year
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Dede Teteh-Brooks, DRPH, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1563
  • NCI-2025-02122 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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