Uptake of Genetic Counseling Among African American Women

Breast Cancer Risk Clinical Trial

Official title:

Creating a Culturally-Tailored Intervention to Improve Uptake of Genetic Counseling Among Underserved African American Women With Increased Breast Cancer Risk

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04082117
• Other study ID #: 2016-1219
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A feasibility study incorporating an educational intervention with cancer genetic risk assessment (CGRA) in the UI Health mammography center

Description:

African American (AA) women with a family history of breast cancer who are eligible for genetic counseling and express an interest in participating in the study will be consented and complete a brief survey before and after viewing an educational video on genetic counseling. Survey questions will be read to each participant. The questions capture data on the following constructs regarding genetic counseling: knowledge, attitudes, normative beliefs, motivation, perceived social norms, intention, efficacy beliefs, skills, environmental constraints and opinions on the video. The research team will conduct a review of the UI Health Electronic Medical Record (EMR) 3-6 months after study enrollment to determine if the participant attended a genetic counseling session.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 960
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 69 Years

Eligibility

Inclusion Criteria:

• African American female age 25-69 years

• Presenting for mammogram at UI Health mammography clinic

• No prior history of breast cancer

• Completed cancer genetic risk assessment (CGRA) in UI Health mammography center

• Recommended for genetic counseling based on CGRA performed at the time of the mammogram.

Exclusion Criteria:

• Unable to complete the informed consent and survey in English

• Previously had genetic counseling for hereditary breast cancer risk

• Prisoners

Related Conditions & MeSH terms

• Breast Cancer Risk
• Breast Neoplasms

Intervention

Behavioral:
• Educational video
Educational genetic counseling video

Locations

Country	Name	City	State
United States	University of Illinois	Chicago	Illinois
United States	University of Illinois Health System	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge and intentions regarding genetic counseling	Change in knowledge of genetic counseling and intention to engage in genetic counseling following viewing of educational video based on response to survey designed by study investigators.	1 hour
Secondary	Attendance at genetic counseling appointment	Rate that study participants attend a genetic counseling appointment within 3 months of viewing educational video	3 months