Clinical trial NCT03624088: CBPR - BRCA Genetic Testing Among Orthodox Jews
Official title: Understanding Social, Cultural, and Religious Factors Influencing BRCA Genetic Testing in the Orthodox Jewish Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer Prevention
Genetic Testing
Orthodox Jewish
Community-Based Participatory Research
BRCA
Decision Support
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in proportion of participants who intend to undergo or have completed genetic testing compared to baseline
timeFrame: 1 month
Secondary outcomes:
measure: Change in proportion of participants who make an informed choice about getting BRCA genetic testing.
timeFrame: 1 month, 6 months
Other outcomes:
measure: Change in proportion of participants who have accurate breast cancer risk perception
timeFrame: 1 month, 6 months
measure: Change in proportion of participants who describe experiencing significant breast cancer worry
timeFrame: 1 month, 6 months
measure: Change in BRCA testing knowledge
timeFrame: 1 month, 6 months
measure: Change in proportion of participants who report positive attitudes towards BRCA genetic testing
timeFrame: 1 month, 6 months
measure: Proportion of patients who experience decision conflict
timeFrame: Baseline, 1 month, 6 months
measure: Proportion of patients who experience decisional regret
timeFrame: 6 months
measure: Change in decision autonomy regarding BRCA testing
timeFrame: 1 month
measure: Change in decision self-efficacy regarding BRCA testing
timeFrame: 1 month
measure: Change in Perceived BRCA mutation risk
timeFrame: 1 month, 6 months
measure: Perception of stigma associated with carrying BRCA mutation
timeFrame: Baseline, 1 month, 6 months
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Katherine D Crew, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: