CBPR - BRCA Genetic Testing Among Orthodox Jews

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624088
• Other study ID #: AAAO1760
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: January 29, 2019

Study information

• Verified date: January 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 29, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in proportion of participants who have accurate breast cancer risk perception	5 questions assessing subject's perceived risk of developing breast cancer on a relative and numeric scale	1 month, 6 months
Other	Change in proportion of participants who describe experiencing significant breast cancer worry	2 questions on a 7-point Likert scale assessing breast cancer worry	1 month, 6 months
Other	Change in BRCA testing knowledge	11 true/false questions to assess knowledge about HBOC genetic testing	1 month, 6 months
Other	Change in proportion of participants who report positive attitudes towards BRCA genetic testing	4 items to assess attitudes towards genetic testing	1 month, 6 months
Other	Proportion of patients who experience decision conflict	10 question scale to assess decision conflict regarding genetic testing	Baseline, 1 month, 6 months
Other	Proportion of patients who experience decisional regret	5 items rated on a 5-point Likert scale to assess views about genetic testing decision	6 months
Other	Change in decision autonomy regarding BRCA testing	15 questions rated on a 7-point Likert scale to assess autonomous self-regulation of health-related behaviors	1 month
Other	Change in decision self-efficacy regarding BRCA testing	11 questions rated on a 5-point Likert scale to assess decision self-efficacy on genetic testing	1 month
Other	Change in Perceived BRCA mutation risk	5-point Likert scale assessing patient's perceived risk of carrying HBOC mutation	1 month, 6 months
Other	Perception of stigma associated with carrying BRCA mutation	8 questions rated on a 7-point Likert scale assessing stigma related BRCA genetic testing	Baseline, 1 month, 6 months
Primary	Change in proportion of participants who intend to undergo or have completed genetic testing compared to baseline	Question assessing subject's intention of undergoing genetic testing or completion of genetic testing	1 month
Secondary	Change in proportion of participants who make an informed choice about getting BRCA genetic testing.	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