Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082117
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 10, 2019
Sponsor:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 2021
Estimated Study Completion Date : May 2021

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.


Layout table for eligibility information
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
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

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 ClinicalTrials.gov identifier (NCT number): NCT04082117


Contacts
Layout table for location contacts
Contact: Kent Hoskins, M.D. 312-355-0496 khoski@uic.edu
Contact: Annette R Kinsella, RN 312-996-5931 annettek@uic.edu

Locations
Layout table for location information
United States, Illinois
University of Illinois Health System Recruiting
Chicago, Illinois, United States, 60612
Contact: Kent Hoskins, M.D.    312-996-1581    khoski@uic.edu   
Contact: Annette R Kinsella, RN    312-996-5931    annettek@uic.edu   
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Kent Hoskins, M.D.    312-355-0496    khoski@uic.edu   
Contact: Annette R Kinsella, RN    312-996-5931    annettek@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Layout table for investigator information
Principal Investigator: Kent Hoskins, M.D. University of Illinois at Chicago
Layout table for additonal information
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: September 9, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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