Attitudes About Childbearing And Fertility With Inherited Breast And Ovarian Cancer Syndromes (HBOC)

Breast Cancer Clinical Trial

Official title:

Attitudes About Childbearing And Fertility In Women Seeking Genetic Testing For Inherited Breast And Ovarian Cancer Syndromes (HBOC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829959
• Other study ID #: 2008-0624
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: August 3, 2016
• Start date: February 2009
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Syndrome

Intervention

Behavioral:
• Questionnaire
1 - 2 questionnaires, lasting 10-15 minutes.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Women Endorsing Prenatal Diagnostic Testing (Questionnaire response)		Baseline and post genetic testing (results disclosure) at 3-4 weeks	No

External Links

•   University of Texas MD Anderson Cancer Center Website