Implementing cascade risk assessment in Black families affected by breast cancer

T
Tarah Ballinger, MD

Primary Investigator

Recruiting
18 years - 100 years
All
Phase N/A
100 participants needed
2 Locations

Brief description of study

Why is this study being done?
The purpose of this study is to test a program for Black women and their families at risk of breast cancer to have access to community health advocates that will help them understand their risk of developing breast cancer, navigate screenings, and access additional ways to reduce their risk.
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?

Once in contact, the BHA will discuss each ARR with the index patient, providing the index patient with messaging for each ARR, inviting each relative to contact the BHA. The BHA will follow up with the index patient at weekly intervals until the index patient has contacted the ARRs.

Once the ARR has contacted the BHA, the study team will consent the ARR to the study using e- consent. We will not reach out directly to ARRs until they have contacted the team as guided by their relative and the BHA. We will record the number of ARRs who are not reached or decline to participate and their reasons for declining, if known.

ARRs who enroll in the study will fill out an electronically delivered baseline survey via Qualtrics, including breast cancer risk factors, screening knowledge, screening behaviors, and screening barriers. Based on the information provided, risk assessments will be performed using the Black Women’s Health Study model17. The research team, led by Dr. Ballinger, who is a breast oncologist and established expert in breast cancer risk assessment, will recommend regular mammography screening if necessary and not yet performed, or the need for consideration of screening MRI and/or tamoxifen medication for risk reduction if indicated for high-risk patients, based on NCCN breast cancer prevention guidelines. ARRs will be provided a summary of their risk and recommendations. An example of this is provided in the appendix and was developed in conjunction with our patient advocate community partners.
                                  
The BHAs will then help navigate the ARR to those screening services and/or a high-risk clinician in their area, identified by the research team. If a high-risk visit is indicated but not available, the BHA will assist with coordination with the patient’s PCP, including a note from the PI and study team. In order to further evaluate the possibility to continue the “cascade,” we will also invite each ARR to identify three self-identifying Black female family members or friends and repeat the same process, outside the scope of this protocol.  

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria

Index Patients

  • Self-identified as Black race
  • DCIS or any stage of breast cancer diagnosed at least 12 months but not more than 10 years prior to enrollment
    a. Date of diagnosis is date of pathology confirming diagnosis.
  • Have at least one female first or second degree relative        

At-risk relatives

  • At birth female sex
  • Blood relative of index patient: sister, mother, grandmother, daughter, aunt, or niece (first- and second-degree relatives by consanguinity)
  • Age  25 and <70
  • No personal history of breast cancer. History of other malignancies is allowed.

Updated on 08 May 2025. Study ID: CTO-IUSCCC-0855, 22131

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