Ovarian Cancer Patient Questionnaire on Genetic Testing

Ovarian Cancer Clinical Trial

Official title:

Questionnaire for Ovarian Cancer Patients Regarding Acceptance and Willingness to Undergo Genetic Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486707
• Other study ID #: 2006-0996
• Status: Completed
• Phase: N/A
• First received: June 13, 2007
• Last updated: July 31, 2012
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Questionnaire
A questionnaire will be completed.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' Response to Survey Questions (Yes/No)		15-20 minutes to complete survey	No

External Links

•   UT MD Anderson Cancer Center