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

This study has been completed.
Sponsor:
Collaborators:
The New School for Social Research
HADASSAH MED CTR, JERUSALEM
New York University
New York Presbyterian Hospital
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00735150
First received: August 12, 2008
Last updated: October 8, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Breast Cancer
Ovarian Cancer
Behavioral: questionnaire, interview

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To explore whether different themes emerge for subgroups of patients (completed childbearing vs. not; affected vs. unaffected). [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To gain preliminary data on themes that might be particularly important to male BRCA1/2 carriers. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735150

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
The New School for Social Research
HADASSAH MED CTR, JERUSALEM
New York University
New York Presbyterian Hospital
Investigators
Principal Investigator: Karen Hurley, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Karen Hurley, PhD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00735150     History of Changes
Other Study ID Numbers: 06-137
Study First Received: August 12, 2008
Last Updated: October 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
Ovary
Mutation carrier

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014