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

Completed

• Conditions: Breast Cancer; Ovarian Cancer
• Interventions: Behavioral: questionnaire, interview

• Registration Number: NCT00735150
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-12
• Study First Posted: 2008-08-14
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-08
• Last Update Posted: 2010-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	questionnaire, interview	25 female and 5 male BRCA carriers

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
To explore whether different themes emerge for subgroups of patients (completed childbearing vs. not; affected vs. unaffected).	conclusion of study
To gain preliminary data on themes that might be particularly important to male BRCA1/2 carriers.	conclusion of study

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States