Ovarian Cancer Patient Questionnaire on Genetic Testing

NCT ID: NCT00486707

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-10-31

Brief Summary

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The objective of this study is to evaluate the willingness of patients with ovarian cancer to undergo genetic testing, given the cost, their understanding and acceptance of genetic testing and the possibility of targeted therapy.

Detailed Description

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All eligible patients being seen in the Gynecology Center at the M.D. Anderson Cancer Center and at Gynecologic Oncology of Houston for follow-up or a new diagnosis of ovarian cancer will be asked to participate in this study by completing a questionnaire.

This study will end when 400 completed questionnaires have been collected. We estimate that 40-60 ovarian cancer patients are seen in the Gynecology Center at the M.D. Anderson Cancer Center each week and that 20- 40 ovarian cancer patients are seen at Gynecologic Oncology of Houston each week. The completion of 400 questionnaires will provide adequate data to address our question in an expeditious time frame. The initial phase of this study is exploratory and does not involve a comparison group.

Conditions

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Ovarian Cancer

Keywords

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Ovarian Cancer Questionnaire Genetic Testing Survey

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with ovarian cancer

Questionnaire

Intervention Type BEHAVIORAL

A questionnaire will be completed.

Interventions

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Questionnaire

A questionnaire will be completed.

Intervention Type BEHAVIORAL

Other Intervention Names

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Survey

Eligibility Criteria

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Inclusion Criteria

* Patients must have the diagnosis of ovarian cancer.
* Patients must be at least 18 years of age at the time of enrollment.
* Patients must be able to read and write in the English language.

Exclusion Criteria

* Patients that are unable to speak or write in the English language. Currently, the investigators' resources in genetic counseling are limited. In the future, they plan to expand the questionnaire and study to include additional languages.
* Patients having previously undergone BRCA genetic testing.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen H. Lu, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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U.T.M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Lacour RA, Daniels MS, Westin SN, Meyer LA, Burke CC, Burns KA, Kurian S, Webb NF, Pustilnik TB, Lu KH. What women with ovarian cancer think and know about genetic testing. Gynecol Oncol. 2008 Oct;111(1):132-6. doi: 10.1016/j.ygyno.2008.06.016. Epub 2008 Aug 6.

Reference Type BACKGROUND
PMID: 18684498 (View on PubMed)

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center

Other Identifiers

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2006-0996

Identifier Type: -

Identifier Source: org_study_id