Decision Support for BRCA Testing in Ethnically Diverse Women

NCT ID: NCT03470402

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2020-08-17

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.

Conditions

Breast Cancer; BRCA1 Mutation; BRCA2 Mutation; Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RealRisks

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

iNYP

Intervention Type: OTHER

Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).

Standard Educational Material

Intervention Type: OTHER

Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic

High-Risk Message

Intervention Type: OTHER

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).

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).

Group Type: ACTIVE_COMPARATOR

iNYP

Intervention Type: OTHER

Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).

Standard Educational Material

Intervention Type: OTHER

Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic

High-Risk Message

Intervention Type: OTHER

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).

Interventions

RealRisks

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.

Intervention Type: OTHER

BNAV

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.

Intervention Type: OTHER

iNYP

Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).

Intervention Type: OTHER

Standard Educational Material

Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic

Intervention Type: OTHER

High-Risk Message

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).

Intervention Type: OTHER

Other Intervention Names

RealRisks Decision Aid; Breast Cancer Risk Navigation Tool; BNAV Toolbox; Standard Educational Brochures; High Risk Letter

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

• Prior genetic counseling or testing for hereditary breast and ovarian cancer (HBOC)
• A personal history of breast or ovarian cancer

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita Kukafka, DrPH, MA

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

Kukafka R, Pan S, Silverman T, Zhang T, Chung WK, Terry MB, Fleck E, Younge RG, Trivedi MS, McGuinness JE, He T, Dimond J, Crew KD. Patient and Clinician Decision Support to Increase Genetic Counseling for Hereditary Breast and Ovarian Cancer Syndrome in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2222092. doi: 10.1001/jamanetworkopen.2022.22092.

Reference Type: DERIVED

PMID: 35849397 (View on PubMed)

Silverman TB, Vanegas A, Marte A, Mata J, Sin M, Ramirez JCR, Tsai WY, Crew KD, Kukafka R. Study protocol: a cluster randomized controlled trial of web-based decision support tools for increasing BRCA1/2 genetic counseling referral in primary care. BMC Health Serv Res. 2018 Aug 13;18(1):633. doi: 10.1186/s12913-018-3442-x.

Reference Type: DERIVED

PMID: 30103738 (View on PubMed)

Other Identifiers

AAAR3676

Identifier Type: -

Identifier Source: org_study_id