Recruiting

BBCSI

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06885203

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Black Breast Cancer Survivor's Intervention

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT06885203

Start date

Aug 27, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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. Self-identify as Black
5. 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 - Community Interventionists

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Immediate Intervention Group

Participants will be recruited through our Community Based Organizations (CBOs) and other community collaborator networks.

experimental: Wait-List (start in week 7)

Participants will be recruited through our Community Based Organizations (CBOs) and other community collaborator networks.

Interventions

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.

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Dede Teteh-Brooks, DRPH

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-12.