- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624088
CBPR - BRCA Genetic Testing Among Orthodox Jews
Understanding Social, Cultural, and Religious Factors Influencing BRCA Genetic Testing in the Orthodox Jewish Community
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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:
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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
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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
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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
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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
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1 month, 6 months
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Change in proportion of participants who report positive attitudes towards BRCA genetic testing
Time Frame: 1 month, 6 months
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4 items to assess attitudes towards genetic testing
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1 month, 6 months
|
Proportion of patients who experience decision conflict
Time Frame: Baseline, 1 month, 6 months
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10 question scale to assess decision conflict regarding genetic testing
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Baseline, 1 month, 6 months
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Proportion of patients who experience decisional regret
Time Frame: 6 months
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5 items rated on a 5-point Likert scale to assess views about genetic testing decision
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6 months
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Change in decision autonomy regarding BRCA testing
Time Frame: 1 month
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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
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11 questions rated on a 5-point Likert scale to assess decision self-efficacy on genetic testing
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1 month
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Change in Perceived BRCA mutation risk
Time Frame: 1 month, 6 months
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5-point Likert scale assessing patient's perceived risk of carrying HBOC mutation
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1 month, 6 months
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Perception of stigma associated with carrying BRCA mutation
Time Frame: Baseline, 1 month, 6 months
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8 questions rated on a 7-point Likert scale assessing stigma related BRCA genetic testing
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Baseline, 1 month, 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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