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EHR Intervention to Increase HBOC Genetic Testing

EHR Intervention to Increase HBOC Genetic Testing

Recruiting
21-75 years
Female
Phase N/A

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Overview

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.

Description

About 5-10% of breast cancers and 10-15% of ovarian cancers are attributed to pathogenic variants (PVs) in cancer predisposition genes, such as BRCA1 and BRCA2. Identifying women with PVs in hereditary breast and ovarian cancer (HBOC) genes can inform risk management strategies, such as enhanced cancer screening, risk-reducing surgeries, and chemoprevention, which have been shown to reduce cancer incidence and mortality. There is significant underutilization of HBOC genetic testing in primary care, with women of color and lower socioeconomic status less likely to receive testing compared to their White or higher income counterparts. Barriers include lack of systematic family history intake, limited access to genetic counseling services, and lack of knowledge among patients and primary care providers (PCPs). The advent of multigene panel testing (MGPT) and rapidly evolving field of cancer genetics have added to the complexity of interpreting genetic test results. To address genetic testing knowledge gaps, the investigators have developed online decision support tools, BNAV (Breast cancer risk NAVigation) for PCPs and RealRisks for patients, which have been rigorously tested among racially/ethnically diverse women in randomized controlled trials (RCTs).

To build upon this prior work, the investigators propose the ELISABETH (Electronic health record \[EHR\]-based implementation strategies and decision support for hereditary breast and ovarian cancer genetic testing among multiethnic women) study.

Eligibility

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.

Study details
    Breast Cancer
    Ovarian Cancer
    Hereditary Cancer Syndrome

NCT07876349

Columbia University

21 October 2026

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