Clinical trial Recruiting at 1 site Interventional Ages 21 to 75 Women only

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 typeInterventional
Ages21 Years to 75 Years
SexWomen only
Enrollment55 (estimated)
SponsorColumbia University
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedSeptember 1, 2026
Main results expectedFebruary 28, 2028
Study endsFebruary 28, 2028
Registry record updatedOctober 15, 2026
Trial IDNCT07876349 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.