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CompletedNCT00829959Updated Aug 4, 2016

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

An observational study in Breast Cancer and Ovarian Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-04.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
156
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer
  • Ovarian Cancer

Keywords

  • Ovary, Cancer
  • Ovarian Cancer
  • Breast Cancer
  • Hereditary Breast and Ovarian Cancer Syndrome
  • HBOC
  • Genetic testing
  • Pregnancy
  • Fertility
  • Prenatal diagnostic testing
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 156 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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).

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

Exclusion Criteria:

  1. None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
156 participants (actual)

Groups and cohorts

  • Genetic Counseling

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

    Behavioral: Questionnaire

Interventions

  • BehavioralQuestionnaire

    1 - 2 questionnaires, lasting 10-15 minutes.

    Also known as: Survey

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What researchers measure

Primary outcomes

  1. Women Endorsing Prenatal Diagnostic Testing (Questionnaire response)

    Time frame: Baseline and post genetic testing (results disclosure) at 3-4 weeks

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Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00829959
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jan 27, 2009
Start date
Feb 2009
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Aug 4, 2016

Study contacts

Jennifer Litton, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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