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NCT Number: NCT06885203

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Master Trainers:

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

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

Participants:

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

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

Community Interventionists:

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

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

General Exclusion Criteria:

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

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

Additional Exclusion Criteria - Community Interventionists

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

Treatment and study plan

Black Breast Cancer Survivor's Intervention

Behavioral

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 outcomes

Safety and Adverse Events (AEs)

Time frame: Time Frame: Through study completion; an average of 1 year

Safety and Adverse Events (AEs)

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2029
First posted: Mar 20, 2025
Registry last updated: Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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