CBPR - BRCA Genetic Testing Among Orthodox Jews

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: RealRisks

• Registration Number: NCT03624088
• Lead Sponsor: Columbia University

Brief Summary

This study evaluates a web-based decision aid, named RealRisks, in promoting genetic testing intention among Orthodox Jewish women. 50 Orthodox Jewish women will take a baseline survey, self-administer the decision aid, and then complete two more surveys: one within one month of completing the decision aid and one at 6 months after completing the decision aid.

Detailed Description

Breast cancer confers significant morbidity and mortality on women in the U.S. and ovarian cancer is the most lethal gynecologic malignancy. Genetic determinants, such as germline mutations in the BRCA1 and BRCA2 genes, confer the greatest impact on breast and ovarian cancer risk. Hereditary breast and ovarian cancer syndrome (HBOC) is an inherited condition that is most commonly associated with mutations in the BRCA1 and BRCA2 genes. An estimated 2-7% of breast cancers and 10-15% of ovarian cancers result from inherited mutations in BRCA1 and BRCA2. Mutation carriers have lifetime risks of breast and ovarian cancer of 40-60% and 20-40%, respectively.

The prevalence of three founder mutations in the BRCA1 and BRCA2 genes is up to 2.5% among Ashkenazi Jews and genetic testing for this 'founder' panel is relatively inexpensive. About 1 in 40 individuals of Ashkenazi (central and eastern European) Jewish descent carry a founder mutation in the BRCA1 (5382insC or 185delAG) or BRCA2 (6174delT) genes. Based upon U.S. PreventiveServices Task Force guidelines, Ashkenazi Jewish women with any first- or second-degree relatives with breast or ovarian cancer should be referred for BRCA genetic counseling.

The perceived benefits and risks of genetic testing may vary by demographic, cultural, and religious backgrounds. Orthodox Jews often consult with Rabbinic and communal authorities in medical decision-making, which is consistent with their religious values. The Jewish community is already familiar with genetic testing due to successful testing programs for genetic disorders, such as Tay-Sachs, an autosomal recessive disease. However, there are unique challenges to testing for BRCA genes, which are inherited in an autosomal dominant fashion and predispose to adult-onset diseases, such as breast and ovarian cancer.

This study will test the efficacy of a patient-centered, web-based decision aid called RealRisks in a pilot study of 50 Orthodox Jewish women, using a pre-/post-test design. Genetic testing intention will be assessed at baseline, within 1 month after exposure to RealRisks, and at 6 months. This pilot study will allow the investigator to determine an effect size that can be used to design a well-powered randomized controlled trial in the future.

The ultimate goal is to understand social, cultural, and religious factors influencing BRCA genetic testing in the Orthodox Jewish community.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-03-13
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Status Verified: 2019-01
• Primary Completion: 2019-01-29
• Study Completion: 2019-01-29
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• >= 25 years of age
• Completed a previous cross-sectional survey and agreed to future contact
• Eligible for BRCA testing based on Six Point Scale

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Exclusion Criteria

• Personal history of breast or ovarian cancer
• Prior genetic counseling or genetic testing for BRCA mutations
• Participated in previous RealRisks workshop

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm Intervention	RealRisks	Participants will complete a baseline questionnaire. They will then self-administer the web-based decision aid, RealRisks. Upon completion, they will complete two more surveys: one within 1 month of completing RealRisks and one six months after completing RealRisks.

Primary Outcome Measures

Name	Time	Method
Change in proportion of participants who intend to undergo or have completed genetic testing compared to baseline	1 month	Question assessing subject's intention of undergoing genetic testing or completion of genetic testing

Secondary Outcome Measures

Name	Time	Method
Change in proportion of participants who make an informed choice about getting BRCA genetic testing.	1 month, 6 months	The degree to which a decision is based on relevant, good quality information, and reflects the decision-maker's values. Calculated using knowledge and attitude scores: to be an informed choice, a patient needs a sufficient knowledge score and a decision that is consistent with their attitude score

Trial Locations

Locations (1)

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