Clinical trial NCT03470402: Decision Support for BRCA Testing in Ethnically Diverse Women
Official title: Decision Support for BRCA Testing in Ethnically Diverse Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Ovarian Cancer
Keywords: Breast Cancer Prevention
Genetic Testing
Genetic Counseling
Personalized Prevention
Precision Prevention
Precision Medicine
Risk Assessment
Decision Making
Decision Aid
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2018-03-20
Enrollment: 276
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake rate of genetic counseling by 6 months
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in patient decision conflict scale score
timeFrame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months
measure: Shared Decision Making (Likert Scale Score)
timeFrame: Post Clinic Encounter (Approximately 6 Weeks)
measure: Patient Informed Choice Score
timeFrame: 6 Months
Other outcomes:
measure: Change in Risk Perceptions (Likert Scale Score)
timeFrame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months
measure: Change in Breast Cancer Worry (Likert Scale Score)
timeFrame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months
measure: Change in Breast Cancer Knowledge scale score
timeFrame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months
measure: Change in Attitudes (Likert Scale Score)
timeFrame: Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months
measure: Change in Decision Self Efficacy (Likert Scale Score)
timeFrame: Baseline, Post Intervention/Control (1 Month), 6 Months
measure: Change in Decision Regret (Likert Scale Score)
timeFrame: Post Clinic Encounter (Approximately 6 Weeks), 6 months
measure: Change in Confidence in Managing Patients with a Family History of Breast/Ovarian Cancer (Likert Scale Score)
timeFrame: Baseline, 6 Months
measure: Change in Provider Knowledge questionnaire score
timeFrame: Baseline, 6 Months
measure: Change in Provider Attitudes
timeFrame: Baseline, 6 Months
measure: Change in Orientation Towards Shared Decision Making (Likert Scale Score)
timeFrame: Baseline, 6 Months
measure: Change in Subjective Norms
timeFrame: Baseline, 6 Months
measure: Change in Perceived behavioral control
timeFrame: Baseline, 6 Months
measure: Change in behavior Intention test score
timeFrame: Baseline, 6 Months
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rita Kukafka, DrPH, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.