Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk

Breast Cancer Clinical Trial

Official title:

Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735150
• Other study ID #: 06-137
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: October 8, 2010
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We are inviting you to participate in a study of how people who have had genetic counseling for breast/ovarian cancer risk feel about certain reproductive technologies, preimplantation genetic diagnosis (PGD) and prenatal genetic diagnosis (PND), that may reduce the chances of passing increased risk onto one's children. We would also like feedback from patients who have been to our clinic in the past on the best ways to talk about PGD and PND during genetic counseling sessions. We are seeking both the opinions of people who are interested in these technologies and those who are not. It does not matter whether you have heard of PGD or PND before - you can still participate. Your past experience with genetic counseling is valuable to us in deciding how to communicate this information during sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Females and males who are carriers of deleterious mutations in the genes BRCA1 or BRCA2.

• Over age 18 and:

1. For women, less than 43

2. For men, less than 50.

• Received genetic testing and counseling for BRCA.

• Fluent in English.

Exclusion Criteria:

• Patients who are currently under treatment (chemotherapy, radiation)

• Individuals who refuse to discuss reproductive issues.

• Unable to give informed consent due to physical, cognitive, or psychiatric disability

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• questionnaire, interview
You will be asked to make a one-time visit to MSKCC. At that research visit, you will be asked to complete a short questionnaire about your knowledge of various reproductive technologies relevant to individuals at hereditary risk. Then you will watch a short presentation about these reproductive technologies and complete a second brief questionnaire to assess your understanding of the presentation. Afterwards, you will meet with an interviewer one-on-one for about one hour, during which time you may share your thoughts and feelings about the use of these reproductive technologies.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	HADASSAH MED CTR, JERUSALEM, New York Presbyterian Hospital, New York University, The New School for Social Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore the attitudes of BRCA1/2 mutation carriers about PGD/PND, most notably benefits and drawbacks, as well as ethical and emotional considerations;		conclusion of study	No
Secondary	To elicit opinions from patients who have previously undergone BRCA1/2 genetic counseling as to when and how information about PGD/PND should be presented (e.g., timing, level of detail,etc)		conclusion of study	No
Secondary	To explore whether different themes emerge for subgroups of patients (completed childbearing vs. not; affected vs. unaffected).		conclusion of study	No
Secondary	To gain preliminary data on themes that might be particularly important to male BRCA1/2 carriers.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center