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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, 2014
Last verified: August 2014

January 26, 2009
August 1, 2014
February 2009
February 2016   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00829959 on ClinicalTrials.gov Archive Site
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Attitudes About Childbearing And Fertility With Inherited Breast And Ovarian Cancer Syndromes (HBOC)
Attitudes About Childbearing And Fertility In Women Seeking Genetic Testing For Inherited Breast And Ovarian Cancer Syndromes (HBOC)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Breast Cancer
  • Ovarian Cancer
Behavioral: Questionnaire
1 - 2 questionnaires, lasting 10-15 minutes.
Other Name: Survey
Genetic Counseling
Women referred to the Clinical Cancer Genetics Program for discussion of Hereditary Breast And Ovarian Syndrome (HBOC).
Intervention: Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
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February 2016   (final data collection date for primary outcome measure)

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

Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829959
2008-0624
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Jennifer Litton, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
August 2014

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