EHR-based approach to boost HBOC genetic testing in at-risk women
Official title: Electronic Health Record-based Implementation Strategies and Decision Support for Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Among Heterogeneous Women (ELISABETH) Pragmatic Trial
Run by Columbia University · NCT07876349 · Data updated 2026-11-12
A new EHR tool-based program tests whether computer prompts and real patient resources can help more women with family histories of breast or ovarian cancer get HBOC genetic testing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 75 Years |
| Sex | Women only |
| Enrollment | 55 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | February 28, 2028 |
| Study ends | February 28, 2028 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07876349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 21-75 with a family history indicating higher risk, no personal breast/ovarian cancer, no prior HBOC testing, and able to use digital tools.
✕Probably not a fit
Women not eligible or not benefiting from decision-support tools may not see a change in testing decisions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates an EHR-enabled strategy to increase the uptake of hereditary breast and ovarian cancer (HBOC) genetic testing among women aged 21-75 seen in selected NY-Presbyterian primary care clinics. It combines clinician decision-support within the EHR with patient-facing resources, including the RealRisks website, to facilitate informed decision-making about testing. The study builds on prior BNAV and RealRisks work and examines how these tools influence testing rates and provider-patient conversations in routine care. Eligible participants are women without a personal cancer history, who meet a family history risk threshold, and have access to digital devices. The trial aims to identify barriers and facilitators to implementation of decision-support tools in real-world primary care settings.
Why it matters
Potential benefit: Participants may gain clearer information and access to HBOC testing, potentially guiding risk management decisions.
How similar studies have gone: Previous randomized trials of RealRisks and BNAV showed positive effects on knowledge and decision-making among diverse populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion criteria: \- Patients who previously participated in the development studies for RealRisks and BNAV.
Where it's running
-
Columbia University Irving Medical Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Katherine Crew, MD — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.