NCT06885203

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
40mo left

Started Aug 2025

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Aug 2025Aug 2029

First Submitted

Initial submission to the registry

March 18, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

August 27, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

March 18, 2025

Last Update Submit

May 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Safety and Adverse Events (AEs)

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

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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

Behavioral: Black Breast Cancer Survivor's Intervention

Wait-List (start in week 7)

EXPERIMENTAL

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

Behavioral: Black Breast Cancer Survivor's Intervention

Interventions

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.

Immediate Intervention GroupWait-List (start in week 7)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +8 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dede Teteh-Brooks, DRPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dede Teteh-Brooks, DRPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 20, 2025

Study Start

August 27, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2029

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations