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

October 8, 2010 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective participants will be recruited through the MSKCC clinics that serve high-risk patients (e.g. Clinical Genetics Service, Special Surveillance Breast Program, etc.)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
25 female and 5 male BRCA carriers
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To explore the attitudes of BRCA1/2 mutation carriers about PGD/PND, most notably benefits and drawbacks, as well as ethical and emotional considerations;
Time Frame: conclusion of study
conclusion of study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

New York University
Hadassah Medical Organization
New York Presbyterian Hospital
The New School for Social Research

Investigators

  • Principal Investigator: Karen Hurley, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

October 11, 2010

Last Update Submitted That Met QC Criteria

October 8, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-137

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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