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Uptake of Genetic Counseling Among African American Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04082117
Recruitment Status : Active, not recruiting
First Posted : September 9, 2019
Last Update Posted : June 24, 2022
Information provided by (Responsible Party):
Kent F. Hoskins, MD, University of Illinois at Chicago

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
Breast Cancer Risk Behavioral: Educational video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Educational 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
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Open Label
Educational genetic counseling video
Behavioral: Educational video
Educational genetic counseling video

Primary Outcome Measures :
  1. Knowledge and intentions regarding genetic counseling [ Time Frame: 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 [ Time Frame: 3 months ]
    Rate that study participants attend a genetic counseling appointment within 3 months of viewing educational video

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04082117

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United States, Illinois
University of Illinois Health System
Chicago, Illinois, United States, 60612
University of Illinois
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
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Principal Investigator: Kent Hoskins, M.D. University of Illinois at Chicago
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kent F. Hoskins, MD, Associate Professor of Medicine, University of Illinois at Chicago Identifier: NCT04082117    
Other Study ID Numbers: 2016-1219
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases