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The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing, the investigators developed a web-based decision aid, RealRisks, which is designed to improve genetic testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in a collaborative dialogue about genetic testing. The study design is a randomized controlled trial of patient educational materials and provider electronic health record (EHR) notice alone (control arm) or in combination with RealRisks and BNAV (intervention arm). The investigators hypothesize that combining the patient-centered RealRisks with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The investigators also hypothesize that genetic counseling decisions will be more informed, and result in less decision conflict and improved shared decision making.
Hereditary breast and ovarian cancer syndrome (HBOC) is an inherited condition that is most commonly associated with mutations in the BRCA1 and BRCA2 genes. Mutation carriers have lifetime risks of breast and ovarian cancer of 60-80% and 20-40%, respectively. Risk management options include intensive breast cancer screening, risk-reducing surgeries, and chemoprevention, which have been shown to improve early detection and reduce cancer incidence and mortality. In particular, prophylactic bilateral salpingo-oophorectomy has been associated with a 60-77%reduction in all-cause mortality among BRCA mutation carriers. Based upon U.S. Preventive Services Task Force guidelines, an estimated 5%-10% of women unaffected with breast cancer are eligible for genetic testing for HBOC, but only 14% of those eligible were referred and 4% had BRCA genetic testing. Many women may be unaware of their high-risk status due to our inability to adequately screen them in the primary care setting. Other reasons for low uptake include inadequate time for counseling and insufficient knowledge about risk-reducing strategies. Women from racial/ethnic minorities are less likely to seek genetic testing for HBOC, contributing to poorer clinical outcomes in these populations compared to non-Hispanic whites. Alternatively, decreasing inappropriate genetics referrals is also important for reducing anxiety and allowing genetic services to be used more efficiently. More research is needed to develop optimal strategies for engaging high-risk women in informed decision-making about genetic testing for HBOC. The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing, the investigators developed a web-based decision aid, RealRisks, which is designed to improve genetic testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in a collaborative dialogue about genetic testing. The study design is a randomized controlled trial of patient educational materials and provider EHR notice alone (control arm) or in combination with RealRisks and BNAV (intervention arm). The investigators hypothesize that combining the patient-centered RealRisks with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The investigators also hypothesize that genetic counseling decisions will be more informed, and result in less decision conflict and improved shared decision making.
Age
21 - 75 years
Sex
FEMALE
Healthy Volunteers
Yes
Columbia University Medical Center
New York, New York, United States
Start Date
December 13, 2017
Primary Completion Date
August 17, 2020
Completion Date
August 17, 2020
Last Updated
April 19, 2021
276
ACTUAL participants
RealRisks
OTHER
BNAV
OTHER
iNYP
OTHER
Standard Educational Material
OTHER
High-Risk Message
OTHER
Lead Sponsor
Columbia University
Collaborators
NCT05673200
NCT05372640
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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