Overview

This trial is active, not recruiting.

Conditions breast cancer, ovarian cancer
Treatment questionnaire
Sponsor M.D. Anderson Cancer Center
Start date February 2009
End date February 2017
Trial size 150 participants
Trial identifier NCT00829959, 2008-0624

Summary

Objectives:

- To evaluate the attitudes and opinions of women undergoing genetic counseling for hereditary breast and ovarian cancer syndrome, both before and after testing, in regards to pregnancy and fertility

Hypothesis:

-Factors that will increase the percentage of women endorsing prenatal diagnostic testing will include a personal history of breast or ovarian cancer, having had a mother or sister die of breast or ovarian cancer, and testing positive for a BRCA mutation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Women referred to the Clinical Cancer Genetics Program for discussion of Hereditary Breast And Ovarian Syndrome (HBOC).
questionnaire Survey
1 - 2 questionnaires, lasting 10-15 minutes.

Primary Outcomes

Measure
Women Endorsing Prenatal Diagnostic Testing (Questionnaire response)
time frame: Baseline and post genetic testing (results disclosure) at 3-4 weeks

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Women who have been referred to the Clinical Cancer Genetics Program for discussion of Hereditary Breast And Ovarian Syndrome (HBOC). 2. Participants must be seen by clinical cancer geneticist and undergo genetic counseling here at M.D. Anderson Cancer Center for HBOC. 3. Participants may or may not have a personal diagnosis of cancer. 4. Participants may have already seen or undergone reproductive endocrine evaluation and had any reproductive treatment. 5. The participant must be a woman and have reproductive potential which would include either active menstruation, blood tests with premenopausal ranges of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and estradiol, or was premenopausal prior to starting chemotherapy for a diagnosed breast cancer. 6. Age >/= 18 years old 7. The patient must be able to speak and read fluently in either English or in Spanish in order to complete the questionnaire. Exclusion Criteria: 1) None

Additional Information

Official title Attitudes About Childbearing And Fertility In Women Seeking Genetic Testing For Inherited Breast And Ovarian Cancer Syndromes (HBOC)
Principal investigator Jennifer Litton, MD
Description This questionnaire is part of a study at The University of Texas M.D. Anderson Cancer Center. The purpose is to ask women who are seeking genetic testing for HBOC their viewpoints surrounding fertility, childbearing and parenting, both at the time of testing and at the time of results disclosure. The aim is to evaluate if the genetics results disclosure may influence women's views regarding these topics. Researchers hope to use this information to provide more information to the patient and the caregiver to help both parties with this very important cancer survivorship issue.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.