Uptake of Genetic Counseling Among African American Women
Primary Purpose
Breast Cancer Risk
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational video
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer Risk
Eligibility Criteria
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
Sites / Locations
- University of Illinois Health System
- University of Illinois
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Open Label
Arm Description
Educational genetic counseling video
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Attendance at genetic counseling appointment
Rate that study participants attend a genetic counseling appointment within 3 months of viewing educational video
Full Information
NCT ID
NCT04082117
First Posted
September 5, 2019
Last Updated
September 19, 2023
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04082117
Brief Title
Uptake of Genetic Counseling Among African American Women
Official Title
Creating a Culturally-Tailored Intervention to Improve Uptake of Genetic Counseling Among Underserved African American Women With Increased Breast Cancer Risk
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A feasibility study incorporating an educational intervention with cancer genetic risk assessment (CGRA) in the UI Health mammography center
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Risk
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Educational genetic counseling video
Masking
None (Open Label)
Allocation
N/A
Enrollment
960 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open Label
Arm Type
Other
Arm Description
Educational genetic counseling video
Intervention Type
Behavioral
Intervention Name(s)
Educational video
Intervention Description
Educational genetic counseling video
Primary Outcome Measure Information:
Title
Knowledge and intentions regarding genetic counseling
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Attendance at genetic counseling appointment
Description
Rate that study participants attend a genetic counseling appointment within 3 months of viewing educational video
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Hoskins, M.D.
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Health System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35752812
Citation
Henderson V, Madrigal JM, Kendall LC, Parekh P, Newsome J, Chukwudozie IB, Comer-Hagans L, Coffey V, Grumbach G, Spencer S, Rodgers C, Kaur R, Balay L, Maga T, Ramamonjiarivelo Z, Balthazar C, Winn R, Watson K, Odoms-Young A, Hoskins KF. Pilot study of a culturally sensitive intervention to promote genetic counseling for breast cancer risk. BMC Health Serv Res. 2022 Jun 25;22(1):826. doi: 10.1186/s12913-022-08193-x.
Results Reference
derived
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Uptake of Genetic Counseling Among African American Women
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