Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-01 @ 10:11 AM
Study NCT ID:
NCT06885203
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Survivors Intervention (BBCSI) course has been developed to help improve the quality of life of Black breast cancer survivors.
A community-based and peer-led Black Breast Cancer Survivors Intervention (BBCSI) course has been developed to help improve the quality of life of Black breast cancer survivors.
Detailed Description:
Primary Objectives:
Guided by the Transcreation Framework for Community-engaged Behavioral Interventions to Reduce Health Disparities (Transcreation Framework), the overall purpose of this study is to determine the feasibility, acceptability, and preliminary efficacy of the proposed biobehavioral community-based and peer-led Black Breast Cancer Survivors Intervention (BBCSI) to improve QOL. To achieve this goal, I have assembled a strong mentorship team with complementary and relevant expertise to pursue the following specific aims:
Specific Aim 1: Develop a prototype of the BBCSI curriculum and assess satisfaction of the intervention. In partnership with two community-based organizations in Georgia and California; and guided by the Transcreation Framework, a prototype of the intervention and associated materials will be developed. Satisfaction of the content, materials, and intervention delivery procedures will be assessed through key informant interviews with Black breast cancer survivors (within two-years of diagnosis) and community interventionists.
Specific Aim 2: Determine the preliminary efficacy of the BBCSI. Using a one group, pre-post intervention design, we will assess improvements in QOL scores, health behaviors, and reduction of parabens in urine samples (markers of product use) of Black breast cancer survivors.
Specific Aim 3: Evaluate fidelity, feasibility, acceptability, barriers, and facilitators of the BBCSI. We will explore fidelity, feasibility, acceptability, barriers, and facilitators of intervention delivery through observation, surveys and key informant interviews with trained peer community interventionists, survivors, and community partner organizations.
The robust evidence of Black women's disproportionate exposure to carcinogenic chemicals that results in cancer-related disparities provides the impetus for this proposed intervention. I seek to fill a critical knowledge gap on developing, implementing, and analyzing community-based interventions. Dr. Teteh-Brook's strong mentorship team consists of leading experts in biological, and social influences on women's health (Glynn); randomized intervention design and implementation (Sun \& Newton); clinical implications of intervention design for Black breast cancer survivors (Brewster); and environmental exposures assessments (Dodson). The PI's long-term career goal is to become an independent, community-based implementation researcher with a focus on environmental exposure behaviors related to Black identity and the proposed K01 application will help reach this goal. This K01 will produce training and findings to support an R01 to conduct a randomized trial of the BBCSI to establish efficacy and potential for dissemination/ implementation. Dr. Teteh-Brooks will use the findings from this proposed research to further refine and develop the trial design, infrastructure, and intervention delivery procedures.
Guided by the Transcreation Framework for Community-engaged Behavioral Interventions to Reduce Health Disparities (Transcreation Framework), the overall purpose of this study is to determine the feasibility, acceptability, and preliminary efficacy of the proposed biobehavioral community-based and peer-led Black Breast Cancer Survivors Intervention (BBCSI) to improve QOL. To achieve this goal, I have assembled a strong mentorship team with complementary and relevant expertise to pursue the following specific aims:
Specific Aim 1: Develop a prototype of the BBCSI curriculum and assess satisfaction of the intervention. In partnership with two community-based organizations in Georgia and California; and guided by the Transcreation Framework, a prototype of the intervention and associated materials will be developed. Satisfaction of the content, materials, and intervention delivery procedures will be assessed through key informant interviews with Black breast cancer survivors (within two-years of diagnosis) and community interventionists.
Specific Aim 2: Determine the preliminary efficacy of the BBCSI. Using a one group, pre-post intervention design, we will assess improvements in QOL scores, health behaviors, and reduction of parabens in urine samples (markers of product use) of Black breast cancer survivors.
Specific Aim 3: Evaluate fidelity, feasibility, acceptability, barriers, and facilitators of the BBCSI. We will explore fidelity, feasibility, acceptability, barriers, and facilitators of intervention delivery through observation, surveys and key informant interviews with trained peer community interventionists, survivors, and community partner organizations.
The robust evidence of Black women's disproportionate exposure to carcinogenic chemicals that results in cancer-related disparities provides the impetus for this proposed intervention. I seek to fill a critical knowledge gap on developing, implementing, and analyzing community-based interventions. Dr. Teteh-Brook's strong mentorship team consists of leading experts in biological, and social influences on women's health (Glynn); randomized intervention design and implementation (Sun \& Newton); clinical implications of intervention design for Black breast cancer survivors (Brewster); and environmental exposures assessments (Dodson). The PI's long-term career goal is to become an independent, community-based implementation researcher with a focus on environmental exposure behaviors related to Black identity and the proposed K01 application will help reach this goal. This K01 will produce training and findings to support an R01 to conduct a randomized trial of the BBCSI to establish efficacy and potential for dissemination/ implementation. Dr. Teteh-Brooks will use the findings from this proposed research to further refine and develop the trial design, infrastructure, and intervention delivery procedures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-02122 | OTHER | NCI-CTRP Clinical Trials Registry | View |