ELISABETH EIP for Hereditary Breast and Ovarian Cancer
(ELISABETH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Katherine Crew, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for women who may be at higher risk for hereditary breast and ovarian cancer due to their family history. Participants should be patients in clinics using electronic health records and interested in learning about genetic testing.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- ELISABETH Evidence-Informed Program (EIP)
Trial Overview
The study is testing whether new tools built into the electronic health record, along with a website called RealRisks, can help increase genetic testing rates for hereditary breast and ovarian cancer among high-risk women.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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