Clinical trial NCT00735150: Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk
Official title: Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Ovarian Cancer
Keywords: Breast
Ovary
Mutation carrier
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: The New School for Social Research
name: Hadassah Medical Organization
name: New York University
name: New York Presbyterian Hospital
First posted: 2008-08-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.)

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.


Eligibility 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

Primary outcomes:
measure: To explore the attitudes of BRCA1/2 mutation carriers about PGD/PND, most notably benefits and drawbacks, as well as ethical and emotional considerations;
timeFrame: conclusion of study
Secondary outcomes:
measure: 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)
timeFrame: conclusion of study
measure: To explore whether different themes emerge for subgroups of patients (completed childbearing vs. not; affected vs. unaffected).
timeFrame: conclusion of study
measure: To gain preliminary data on themes that might be particularly important to male BRCA1/2 carriers.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Karen Hurley, PhD
role: PRINCIPAL_INVESTIGATOR
References: