CClinicalTrials.gg
Active, not recruitingNCT04082117Updated Jul 14, 2025

Uptake of Genetic Counseling Among African American Women

An interventional study of Educational video in Breast Cancer Risk, sponsored by University of Illinois at Chicago. Active, not recruiting at 2 sites in United States. Open to female participants aged 25 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-07-14.

Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as active, not recruiting.
  • Registered 2 years 3 months after the study started (first participant enrolled May 2017, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
960
Allocation
Not applicable
Ages
25 Years to 69 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breast Cancer Risk
03

In context

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 69 Years
Sexes eligible
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

Exclusion Criteria:

  • Unable to complete the informed consent and survey in English
  • Previously had genetic counseling for hereditary breast cancer risk
  • Prisoners
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
960 participants (estimated)

Study arms

  • Other
    Open Label

    Educational genetic counseling video

    Behavioral: Educational video

Interventions

  • BehavioralEducational video

    Educational genetic counseling video

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

Secondary outcomes

  1. Attendance at genetic counseling appointment

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

    Time frame: 3 months

07

Study locations

2 sites
  • University of Illinois Health System
    Chicago, Illinois 60612, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
08

References and documents

Publications

  • 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. PubMed 35752812 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04082117
Lead sponsor
University of Illinois at Chicago
Responsible party
Kent F. Hoskins, MD (Associate Professor of Medicine, University of Illinois at Chicago) — Principal investigator
First posted
Sep 9, 2019
Start date
May 12, 2017
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Jul 14, 2025

Study contacts

Kent Hoskins, M.D.
principal investigator · University of Illinois at Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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