Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Black Breast Cancer Survivor's Intervention.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Safety and Adverse Events (AEs) [Time frame: Time Frame: Through study completion; an average of 1 year]
Eligibility criteria
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
1\. Has not previously participated in and completed the study intervention as a participant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- The University of Texas M. D. Anderson Cancer Center — Houston
Identifiers
NCT: NCT06885203 · 2024-1563 · NCI-2025-02122