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OpenTrials
Completed

NCT Number: NCT00735150

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

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females and males who are carriers of deleterious mutations in the genes BRCA1 or BRCA2.
  • Over age 18 and:
  • For women, less than 43
  • 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

Treatment and study plan

questionnaire, interview

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. To explore whether different themes emerge for subgroups of patients (completed childbearing vs. not; affected vs. unaffected).

    Time frame: conclusion of study

  3. To gain preliminary data on themes that might be particularly important to male BRCA1/2 carriers.

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

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

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2008
Registry last updated
Oct 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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