Electronic Health Record-based Implementation Strategies and Decision Support for Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Among Heterogeneous Women (ELISABETH) Pragmatic Trial
Columbia University
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.
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 th…
Eligibility
- Age range
- 21–75 years
- Sex
- Female
- Healthy volunteers
- No
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.
Interventions
- BehavioralELISABETH Evidence-Informed Program (EIP)
* Family history screening * Patient and provider BPA (Best Practice Alert) notifications * Referral information for genetic counseling * No RealRisks/BNAV (Breast cancer risk navigation) tools * No streamlined MGPT (multigene panel testing) implementation pathway
Location
- Columbia University Irving Medical CenterNew York, New York