CBPR - BRCA Genetic Testing Among Orthodox Jews

January 30, 2019 updated by: Katherine D. Crew, Columbia University

Understanding Social, Cultural, and Religious Factors Influencing BRCA Genetic Testing in the Orthodox Jewish Community

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single-Arm Intervention
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.
Behavioral: 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.
Other Names:
  • RealRisks Decision Aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proportion of participants who intend to undergo or have completed genetic testing compared to baseline
Time Frame: 1 month
Question assessing subject's intention of undergoing genetic testing or completion of genetic testing
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proportion of participants who make an informed choice about getting BRCA genetic testing.
Time Frame: 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
1 month, 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proportion of participants who have accurate breast cancer risk perception
Time Frame: 1 month, 6 months
5 questions assessing subject's perceived risk of developing breast cancer on a relative and numeric scale
1 month, 6 months
Change in proportion of participants who describe experiencing significant breast cancer worry
Time Frame: 1 month, 6 months
2 questions on a 7-point Likert scale assessing breast cancer worry
1 month, 6 months
Change in BRCA testing knowledge
Time Frame: 1 month, 6 months
11 true/false questions to assess knowledge about HBOC genetic testing
1 month, 6 months
Change in proportion of participants who report positive attitudes towards BRCA genetic testing
Time Frame: 1 month, 6 months
4 items to assess attitudes towards genetic testing
1 month, 6 months
Proportion of patients who experience decision conflict
Time Frame: Baseline, 1 month, 6 months
10 question scale to assess decision conflict regarding genetic testing
Baseline, 1 month, 6 months
Proportion of patients who experience decisional regret
Time Frame: 6 months
5 items rated on a 5-point Likert scale to assess views about genetic testing decision
6 months
Change in decision autonomy regarding BRCA testing
Time Frame: 1 month
15 questions rated on a 7-point Likert scale to assess autonomous self-regulation of health-related behaviors
1 month
Change in decision self-efficacy regarding BRCA testing
Time Frame: 1 month
11 questions rated on a 5-point Likert scale to assess decision self-efficacy on genetic testing
1 month
Change in Perceived BRCA mutation risk
Time Frame: 1 month, 6 months
5-point Likert scale assessing patient's perceived risk of carrying HBOC mutation
1 month, 6 months
Perception of stigma associated with carrying BRCA mutation
Time Frame: Baseline, 1 month, 6 months
8 questions rated on a 7-point Likert scale assessing stigma related BRCA genetic testing
Baseline, 1 month, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 13, 2018

Primary Completion (ACTUAL)

January 29, 2019

Study Completion (ACTUAL)

January 29, 2019

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (ACTUAL)

August 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAO1760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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