NCT04082117

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
960

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

9 years

First QC Date

September 5, 2019

Last Update Submit

July 9, 2025

Conditions

Outcome Measures

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.

    1 hour

Secondary Outcomes (1)

  • Attendance at genetic counseling appointment

    3 months

Study Arms (1)

Open Label

OTHER

Educational genetic counseling video

Behavioral: Educational video

Interventions

Educational genetic counseling video

Open Label

Eligibility Criteria

Age25 Years - 69 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois Health System

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Kent Hoskins, M.D.

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Educational genetic counseling video
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

May 12, 2017

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations