Decision Support for BRCA Testing in Ethnically Diverse Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Uptake rate of genetic counseling by 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(Patient Participants):
- •Women, age 21-75 years
- •Meets criteria for genetic testing based on family history
- •Sees a primary care provider in the Columbia University (CUMC) /New York Presbyterian (NYP) Ambulatory Care Network
- •Understands as is willing to provide informed consent in English or in Spanish
排除标准
- •(Patient Participants):
- •Prior genetic counseling or testing for hereditary breast and ovarian cancer (HBOC)
- •A personal history of breast or ovarian cancer
- •Inclusion Criteria (Health Care Provider Participants):
- •Primary care providers, such as attending physicians, residents, nurse practitioners, physician assistants, and midwives, who see patients at CUMC/NYP Ambulatory Care Network clinics
- •Able to provide informed consent
研究组 & 干预措施
Intervention group
Women who screen as eligible for BRCA genetic counseling will receive the education and decision support tool, RealRisks, along with standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).
The enrolled health care providers of these women will be given access to BNAV, which summarizes their enrolled patients' breast cancer risk profiles and provides educational resources on genetic testing and prevention options. Before their clinical encounter with an enrolled patient, these providers will also be sent the personalized breast cancer risk summary that is created by data the patient entered into RealRisks.
干预措施: RealRisks (Other)
Intervention group
Women who screen as eligible for BRCA genetic counseling will receive the education and decision support tool, RealRisks, along with standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).
The enrolled health care providers of these women will be given access to BNAV, which summarizes their enrolled patients' breast cancer risk profiles and provides educational resources on genetic testing and prevention options. Before their clinical encounter with an enrolled patient, these providers will also be sent the personalized breast cancer risk summary that is created by data the patient entered into RealRisks.
干预措施: BNAV (Other)
Intervention group
Women who screen as eligible for BRCA genetic counseling will receive the education and decision support tool, RealRisks, along with standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).
The enrolled health care providers of these women will be given access to BNAV, which summarizes their enrolled patients' breast cancer risk profiles and provides educational resources on genetic testing and prevention options. Before their clinical encounter with an enrolled patient, these providers will also be sent the personalized breast cancer risk summary that is created by data the patient entered into RealRisks.
干预措施: iNYP (Other)
Intervention group
Women who screen as eligible for BRCA genetic counseling will receive the education and decision support tool, RealRisks, along with standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).
The enrolled health care providers of these women will be given access to BNAV, which summarizes their enrolled patients' breast cancer risk profiles and provides educational resources on genetic testing and prevention options. Before their clinical encounter with an enrolled patient, these providers will also be sent the personalized breast cancer risk summary that is created by data the patient entered into RealRisks.
干预措施: Standard Educational Material (Other)
Intervention group
Women who screen as eligible for BRCA genetic counseling will receive the education and decision support tool, RealRisks, along with standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).
The enrolled health care providers of these women will be given access to BNAV, which summarizes their enrolled patients' breast cancer risk profiles and provides educational resources on genetic testing and prevention options. Before their clinical encounter with an enrolled patient, these providers will also be sent the personalized breast cancer risk summary that is created by data the patient entered into RealRisks.
干预措施: High-Risk Message (Other)
Control group
Women who screen as eligible for BRCA genetic counseling will receive standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).
干预措施: iNYP (Other)
Control group
Women who screen as eligible for BRCA genetic counseling will receive standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).
干预措施: Standard Educational Material (Other)
Control group
Women who screen as eligible for BRCA genetic counseling will receive standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).
干预措施: High-Risk Message (Other)
结局指标
主要结局
Uptake rate of genetic counseling by 6 months
时间窗: Up to 6 months
The primary endpoint is to determine the uptake of genetic counseling for HBOC syndrome by 6 months in the intervention arm (RealRisks Decision Aid and BNAV toolbox) compared to the control arm (Standard educational materials)
次要结局
- Change in patient decision conflict scale score(Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months)
- Shared Decision Making (Likert Scale Score)(Post Clinic Encounter (Approximately 6 Weeks))
- Patient Informed Choice Score(6 Months)