NCT00829959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

7.5 years

First QC Date

January 26, 2009

Last Update Submit

August 3, 2016

Conditions

Keywords

Ovary, CancerOvarian CancerBreast CancerHereditary Breast and Ovarian Cancer SyndromeHBOCGenetic testingPregnancyFertilityPrenatal diagnostic testing

Outcome Measures

Primary Outcomes (1)

  • Women Endorsing Prenatal Diagnostic Testing (Questionnaire response)

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

Study Arms (1)

Genetic Counseling

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

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

1 - 2 questionnaires, lasting 10-15 minutes.

Also known as: Survey
Genetic Counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \) None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsOvarian NeoplasmsHereditary Breast and Ovarian Cancer Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jennifer Litton, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations