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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT00829959

First received: January 26, 2009

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2009

Last Updated Date

August 1, 2012

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Women Endorsing Prenatal Diagnostic Testing (Questionnaire response) [ Time Frame: Baseline and post genetic testing (results disclosure) at 3-4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00829959 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Women undergoing genetic counseling within UT MDACC Clinical Cancer Genetics Program for hereditary breast and ovarian cancer syndrome (HBOC).

Condition ^ICMJE

Breast Cancer
Ovarian Cancer

Intervention ^ICMJE

Behavioral: Questionnaire

1 - 2 questionnaires, lasting 10-15 minutes.

Other Name: Survey

Study Group/Cohort (s)

Genetic Counseling

Women referred to the Clinical Cancer Genetics Program for discussion of Hereditary Breast And Ovarian Syndrome (HBOC).

Intervention: Behavioral: Questionnaire

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Completion Date

Not Provided

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women who have been referred to the Clinical Cancer Genetics Program for discussion of Hereditary Breast And Ovarian Syndrome (HBOC).
Participants must be seen by clinical cancer geneticist and undergo genetic counseling here at M.D. Anderson Cancer Center for HBOC.
Participants may or may not have a personal diagnosis of cancer.
Participants may have already seen or undergone reproductive endocrine evaluation and had any reproductive treatment.
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.
Age >/= 18 years old
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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00829959

Other Study ID Numbers ^ICMJE

2008-0624

Has Data Monitoring Committee

Responsible Party

M.D. Anderson Cancer Center

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jennifer Litton, MD

UT MD Anderson Cancer Center

Information Provided By

M.D. Anderson Cancer Center

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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