Decision Support for BRCA Testing in Ethnically Diverse Women
Condition: Breast Cancer; BRCA1 Mutation; BRCA2 Mutation; Ovarian Cancer
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): RealRisks; BNAV; iNYP; Standard Educational Material; High-Risk Message
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): RealRisks is a web-based patient decision aid with modules on risk assessment, family history and breast cancer, genetic testing, and prevention options. Participants enter family history data into RealRisks, and RealRisks calculates 5-year breast cancer risk, lifetime breast cancer risk, and the probability of carrying a BRCA mutation. This information is then interactively presented to the participant. RealRisks facilitates the participant in identifying their intention to undergo BRCA genetic testing and the factors that are important to the participant in making this decision. RealRisks produces a summary of all of this information that the participant can print and take with her to a health care appointment.; BNAV is a web-based decision support tool for healthcare providers with educational modules on genetic testing, chemoprevention, patient-centered care, and screening. BNAV also provides providers with a table outlining their enrolled patients' breast cancer risk, eligibility for genetic testing, and stated preferences.; Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).; Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic; Enrolled patient participants will receive a letter that informs them that they meet eligibility criteria for BRCA genetic testing, outlines prevention options, and recommends discussing genetic counseling referral with their health care provider (standard practice).
Other intervention name(s): RealRisks Decision Aid; Breast Cancer Risk Navigation Tool; BNAV Toolbox; Standard Educational Brochures; High Risk Letter
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A cluster randomization in which both a provider and his/her enrolled patients will be enrolled in either the intervention or control arm.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast Cancer Prevention; Genetic Testing; Genetic Counseling; Personalized Prevention; Precision Prevention; Precision Medicine; Risk Assessment; Decision Making; Decision Aid