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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06885203
Enrollment
56
Registered
2025-03-20
Start date
2025-08-27
Completion date
2029-08-31
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

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

BEHAVIORALBlack 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.

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safety and Adverse Events (AEs)Time Frame: Through study completion; an average of 1 yearSafety and Adverse Events (AEs)

Countries

United States

Contacts

CONTACTDede Teteh-Brooks, DRPH
dkteteh@mdanderson.org713-563-3493
PRINCIPAL_INVESTIGATORDede Teteh-Brooks, DRPH

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026