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Uptake of Genetic Counseling Among African American Women

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04082117
Collaborator
(none)
960
Enrollment
2
Locations
1
Arm
83.6
Anticipated Duration (Months)
480
Patients Per Site
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational video
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
960 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Educational genetic counseling videoEducational genetic counseling video
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Creating a Culturally-Tailored Intervention to Improve Uptake of Genetic Counseling Among Underserved African American Women With Increased Breast Cancer Risk
Actual Study Start Date :
May 12, 2017
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Open Label

Educational genetic counseling video

Behavioral: Educational video
Educational genetic counseling video

Outcome Measures

Primary Outcome Measures

  1. Knowledge and intentions regarding genetic counseling [1 hour]

    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.

Secondary Outcome Measures

  1. Attendance at genetic counseling appointment [3 months]

    Rate that study participants attend a genetic counseling appointment within 3 months of viewing educational video

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 69 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois Health System Chicago Illinois United States 60612
2 University of Illinois Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago

Investigators

  • Principal Investigator: Kent Hoskins, M.D., University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kent F. Hoskins, MD, Associate Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT04082117
Other Study ID Numbers:
  • 2016-1219
First Posted:
Sep 9, 2019
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Jun 24, 2022