Promoting Genetic Counseling Among African American Women With a Family History of Breast Cancer

NCT04378751 | Completed

• 2 other identifiers: 2020-0342K01CA248852-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

In the United States, carriers of hereditary genetic mutations have up to an 85% risk of developing breast cancer compared to 12% in the general population. Overall uptake of genetic services is generally low, particularly among high-risk African American (AA) women, who carry a disproportionate burden of breast cancer mortality. Further, although testing close relatives of individuals who test positive for a pathogenic variant might curtail breast cancer disparities attributable to hereditary risk, it is unclear how counseled or tested individuals influence their social and familial networks. Using a randomized control trial design, the objective of this research project is to test the effectiveness of a culturally targeted video, previously developed by our research team, on promoting genetic counseling attendance among AA women determined to be at high risk for breast cancer through cancer genetic risk assessment in a clinical setting. This study will also test how psychosocial factors (knowledge, intrinsic motivation, risk perception, and distress) impact the relationships between intervention exposures (video versus brochure) and compare the impact of intervention exposures on diffusion of knowledge about genetic counseling through social network analysis.

Conditions

High Risk for Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Genetic Counseling Attendance

  Compare the effects of intervention vs. control arm on genetic counseling attendance among African American women recommended for genetic counseling through cancer genetic risk assessment. Assessed via EMR and survey at follow-up. 2-item (Did patient complete genetic counseling appointment? A) Self-report and B) EMR) 1 items assessing familial referral to genetic counseling or testing

  52 weeks

Secondary Outcomes (6)

• Decision Aid Usability

  52 weeks

• Knowledge about Genetic Counseling

  52 weeks

• Distress Associated with Genetic Counseling and Breast Cancer Risk

  52 weeks

• Intrinsic Motivation for Genetic Counseling Attendance

  52 weeks

• Risk Perception Associated with Breast Cancer

  52 weeks

Study Arms (2)

Decision aid video

EXPERIMENTAL

Participants receiving the intervention will complete a pretest, watch the decision aid video, and complete posttest via tablet computer facilitated by Patient Navigators.

Behavioral: Decision aid video

Genetic counseling informational brochure

ACTIVE COMPARATOR

Participants receiving the control will complete pretest, review a genetic counseling brochure with the Patient Navigators, and complete posttest via tablet computer facilitated by a Patient Navigator.

Behavioral: Genetic counseling informational brochure

Interventions

Decision aid video BEHAVIORAL

Decision aid video

Decision aid video

Genetic counseling informational brochure BEHAVIORAL

Genetic counseling informational brochure

Genetic counseling informational brochure

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are female
• Identify as African American
• Are age 25 or older
• Speak and understand English
• Completed a cancer genetic risk assessment (CGRA) as part of clinic intake
• Are classified as high risk for developing breast cancer per CGRA
• Have not previously received genetic counseling

You may not qualify if:

• Are not female
• Do not identify as African American
• Are age 24 or younger
• Do not speak and understand English
• Did not complete a cancer genetic risk assessment (CGRA) as part of clinic intake
• Are not classified as high risk for developing breast cancer per CGRA
• Have previously received genetic counseling

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UIC Cancer Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago Hospital and Ambulatory Clinics

Chicago, Illinois, 60612, United States

Location

Study Officials

• Kent Hoskins, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Computer-generated randomization (equal numbers in each arm), patients will be randomized to one of two arms: 1. Decision aid video 2. Genetic counseling informational brochure

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 7, 2020
• Study Start: June 6, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

US (2)