An interventional study of ELISABETH Evidence-Informed Program (EIP) in Breast Cancer, Ovarian Cancer and Hereditary Cancer Syndrome, sponsored by Columbia University. Recruiting at 1 site in United States. Open to female participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 55 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Exclusion criteria:
- Patients who previously participated in the development studies for RealRisks and BNAV.
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.
Behavioral: ELISABETH 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
Genetic Testing Knowledge
Change in hereditary breast and ovarian cancer (HBOC) genetic testing knowledge, assessed using an 11-item true/false questionnaire evaluating knowledge of HBOC genetic testing. Total score ranges from 0 to 11, with higher scores indicating greater genetic testing knowledge
Time frame: Baseline to 1 month
Threat Beliefs
Perceived susceptibility will be assessed using a 3-item measure evaluating perceived risk of developing cancer, likelihood that cancer is hereditary in the family, and risk for healthy relatives. Responses are expressed as percent risk estimates. Higher scores indicate greater perceived susceptibility.
Time frame: at baseline, 1 month, and 6 months
Uncertainty
Uncertainty regarding genetic testing will be assessed using a 3-item scale adapted from the Multidimensional Impact of Cancer Risk Assessment (MICRA). The full scale ranges from 0 to 5. Higher scores indicate greater uncertainty related to genetic testing and results.
Time frame: 1 month and 6 months
Cancer-related distress assessed using the 15-item Impact of Event Scale (IES)
The measure evaluates intrusive thoughts and avoidant thinking related to genetic testing. The full scale ranges from 0 to 5. Higher scores indicate greater cancer-specific distress.
Time frame: Baseline, 1 month, and 6 months
Decisional Conflict
The Decisional Conflict Scale measures uncertainty regarding the decision to undergo genetic testing and receive results. The full scale ranges from 0 to 100. Higher scores indicate greater decisional conflict.
Time frame: 1 month and 6 months
Attitudes Toward Receiving Genetic Test Results
Attitudes regarding receipt of genetic test results will be assessed using a 6-item scale. Responses are scored from 1 to 7 and averaged to create a total score. Higher scores indicate more favorable attitudes toward receiving genetic test results.
Time frame: Baseline and 1 month
Understanding Genetic Test Results
Self-reported understanding of genetic test results, including positive, likely positive, variant of uncertain significance, negative, or unclear results. The outcome will be reported as proportion of participants who correctly understand their genetic test results.
Time frame: 6 months
Utilization of Genetic Test Results
Proportion of participants reporting that genetic test results influenced decisions regarding prophylactic surgery, chemoprevention, additional cancer screening, or adoption of risk-reducing behaviors.
Time frame: 6 months
Behavioral Intention
Behavioral intention regarding genetic testing and risk management behaviors, assessed through participant-reported intentions to engage in recommended preventive actions during the next 12 months. The full scale ranges from 1 to 5. Higher scores indicate stronger behavioral intention.
Time frame: 6 months
Family Communication
Proportion of participants who communicate genetic test results to family members and discuss family genetic testing and/or risk-reducing behaviors.
Time frame: 6 months
Started Sep 2026 (actual). Primary completion is estimated for Feb 2028, 17 months after the start.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 17 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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