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Electronic Health Record-based Implementation Strategies and Decision Support for Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Among Heterogeneous Women (ELISABETH) Pragmatic Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this research study is to test how well a new approach - using tools built into the electronic health record (EHR)- can help increase genetic testing for hereditary breast and ovarian cancer (HBOC) in women who have a family history that puts them at higher risk. The study will also look at what helps or gets in the way of using these tools in everyday clinical care. As part of this study, the investigators are also evaluating a website called RealRisks, which is designed to support patients in understanding their risk and making informed decisions about genetic testing. By studying how patients and primary care providers use this tool, the investigators hope to improve the way decision support tools are used to guide conversations and decisions about HBOC testing.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• Women, age 21-75 years

• Completed Six-Point Scale (SPS) family history screener with a score of 6 or higher.

• Seen in NewYork Presbyterian primary care clinic selected for pilot testing

• No personal history of breast or ovarian cancer

• No prior germline HBOC genetic testing

• English or Spanish-speaking

• Access to a smartphone, tablet, or computer

• Able to provide written, verbal, or online informed consent

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162
Time Frame
Start Date: 2026-09-01
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 55
Treatments
Experimental: ELISABETH Evidence-Informed Program (EIP)
The ELISABETH evidence-informed program (EIP) to increase HBOC genetic testing in primary care includes: 1) systematic family history intake among women, age 21-75 years, during screening mammography and gynecology clinic visits; 2) tracking patients who meet family history criteria for HBOC genetic testing; 3) notifying patients and primary care providers (PCPs) of positive screens; 4) integrating patient and provider decision support into clinical workflow; 5) facilitating genetic counseling referrals and mainstream genetic testing; 6) providing training for clinic staff to order mainstream genetic testing and deliver post-test counseling for return of results (RoR); 7) providing follow-up care for high-risk patients.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov