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

August 3, 2016 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Genetic Counseling
Women referred to the Clinical Cancer Genetics Program for discussion of Hereditary Breast And Ovarian Syndrome (HBOC).
Behavioral: Questionnaire
1 - 2 questionnaires, lasting 10-15 minutes.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Jennifer Litton, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0624

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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