Decision Support for BRCA Testing in Ethnically Diverse Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Decision Support for BRCA Testing in Ethnically Diverse Women

Conditions
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Breast Cancer, BRCA1 Mutation, BRCA2 Mutation, Ovarian Cancer

Intervention / Treatment
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* Other: RealRisks
* Other: BNAV
* Other: iNYP
* Other: Standard Educational Material
* Other: High-Risk Message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (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 Exclusion Criteria (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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: RealRisks<br>* 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.<br>* Other names: RealRisks Decision Aid;Other: BNAV<br>* 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.<br>* Other names: BNAV Toolbox;Other: iNYP<br>* Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).<br>Other: Standard Educational Material<br>* Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic<br>* Other names: Standard Educational Brochures;Other: High-Risk Message<br>* 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).<br>* Other names: High Risk Letter;|
| Active Comparator: Control group<br>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). | Other: iNYP<br>* Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).<br>Other: Standard Educational Material<br>* Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic<br>* Other names: Standard Educational Brochures;Other: High-Risk Message<br>* 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).<br>* Other names: High Risk Letter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake rate of genetic counseling by 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) | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient decision conflict scale score | The decisional conflict scale (DCS) measures personal perceptions of: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. It includes 10 yes/no items (0=yes, 2=unsure, 4=no). Analysis: Item scores are summed, divided by 10, and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). A lower score indicates a better outcome. | Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months | 
| Shared Decision Making (Likert Scale Score) | The Shared Decision Making (SDM) questionnaire collects information on the process in which clinicians and patients work together to make decisions and select tests, treatments and care plans based on clinical evidence that balances risks and expected outcomes with patient preferences and values. It consists of 9 items with each item scored on a 6-point Likert scale (0=completely disagree to 5=Complete Agree) from the SDM-Q-9. Analysis: A raw total score between 0 and 45 calculated by summing the scores of all items. If required, imputation of up to two missing items using the mean of the items that made up the raw score. For the standardization of the raw score, a linear transformation into a scale ranging from 0 to 100 (multiplication of the raw score by 20/9), with zero indicating the lowest level of perceived SDM and 100 indicating the highest level of perceived SDM (better outcome). | Post Clinic Encounter (Approximately 6 Weeks) | 
| Patient Informed Choice Score | The degree to which a decision is based on relevant, good quality information, and reflects the decision-maker's values. To compare between the intervention and control group at 6 months. To be an informed choice, a patient needs a good knowledge score and a decision that is consistent with their attitude score. Analysis: Informed Choice= Good knowledge (score 50% and above) AND Positive Attitude (score 22 and above) AND positive decision (I decided to get genetic testing or I was already tested), OR Good knowledge AND Negative attitude (score 21 and below) AND negative decision (I decided not to get genetic testing) Uninformed Choice: Poor knowledge, OR Good knowledge, but uptake inconsistent with attitudes Analysis: Uninformed Choice= Good knowledge (score 50% and above) AND Negative attitude AND positive decision OR Good knowledge AND Negative Attitude Score AND positive decision, OR Poor knowledge (49% and below). | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Making, Decision Aid, Breast Cancer Prevention, Genetic Testing, Genetic Counseling, Personalized Prevention, Precision Prevention, Precision Medicine, Risk Assessment