Decision Support for BRCA Testing in Ethnically Diverse Women

Not Applicable

Completed

• Conditions: Breast Cancer; BRCA1 Mutation; Ovarian Cancer; BRCA2 Mutation
• Interventions: Other: iNYP; Other: RealRisks; Other: BNAV; Other: Standard Educational Material; Other: High-Risk Message

• Registration Number: NCT03470402
• Lead Sponsor: Columbia University

Brief 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.

Study Timeline

• Study Start: 2017-12-13
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-20
• Primary Completion: 2020-08-17
• Study Completion: 2020-08-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-15
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 276

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	iNYP	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).
Intervention group	RealRisks	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.
Intervention group	BNAV	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.
Intervention group	iNYP	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.
Intervention group	Standard Educational Material	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.
Intervention group	High-Risk Message	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.
Control group	High-Risk Message	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).
Control group	Standard Educational Material	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).

Primary Outcome Measures

Name	Time	Method
Uptake rate of genetic counseling by 6 months	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)

Secondary Outcome Measures

Name	Time	Method
Change in patient decision conflict scale score	Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months	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.
Shared Decision Making (Likert Scale Score)	Post Clinic Encounter (Approximately 6 Weeks)	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).
Patient Informed Choice Score	6 Months	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).

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States