CBPR - BRCA Genetic Testing Among Orthodox Jews
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|ClinicalTrials.gov Identifier: NCT03624088|
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: RealRisks||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Understanding Social, Cultural, and Religious Factors Influencing BRCA Genetic Testing in the Orthodox Jewish Community|
|Actual Study Start Date :||March 13, 2018|
|Actual Primary Completion Date :||January 29, 2019|
|Actual Study Completion Date :||January 29, 2019|
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 Name: RealRisks Decision Aid
- 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
- 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
- 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
- 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
- Change in BRCA testing knowledge [ Time Frame: 1 month, 6 months ]11 true/false questions to assess knowledge about HBOC genetic testing
- 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
- Proportion of patients who experience decision conflict [ Time Frame: Baseline, 1 month, 6 months ]10 question scale to assess decision conflict regarding genetic testing
- 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
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624088
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Katherine D Crew, MD, MS||Columbia University|