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Study of Decision Making in Patients Enrolled in a Phase I Clinical Trial

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Study of Decision Making in Patients Participating in Phase I Clinical Trials

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Educational/Counseling/Training Active 18 and over NCI NCI-03-C-0063
NCT00054223

Special Category: NIH Clinical Center trial

Objectives

Determine the range of personality traits of patients enrolled in a phase I clinical trial.
Determine these patients' understanding of their medical situation and prognosis.
Determine these patients' understanding of risks and benefits of phase I clinical trials.
Determine these patients' reasons for participating in a phase I clinical trial.
Determine the risk/benefit trade-offs of these patients.
Determine the existential outlook of these patients.
Determine the information gathering nature of these patients.

Entry Criteria

Disease Characteristics:

Consented to enrollment in a phase I cancer clinical trial

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

No concurrent enrollment in other clinical trials evaluating phase I patient attitudes

Patient Characteristics:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Understands written English

Expected Enrollment

250

Approximately 250 patients will be accrued for this study within 6 months.

Outline

This is a multicenter study.

Before beginning phase I clinical trial treatment, patients complete a survey over 30-45 minutes administered by an interviewer. Patients then self-administer the Temperament and Character Inventory assessment over 30 minutes.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Manish Agrawal, MD, Protocol chair
Ph: 301-435-8724
Email: agrawalm@mail.nih.gov

Trial Sites

U.S.A.

Illinois

Chicago

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Ph: 312-695-1301

Email: cancer@northwestern.edu

Maryland

Bethesda

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Contact Person
Ph: 888-NCI-1937

Pennsylvania

Philadelphia

Fox Chase Cancer Center - Philadelphia

Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790

Texas

Houston

M. D. Anderson Cancer Center at University of Texas

Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas
Ph: 713-792-3245

San Antonio

Cancer Therapy and Research Center

Clinical Trials Office - Cancer Therapy and Research Center
Ph: 210- 616-5798

Registry Information

Official Title		Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients

Trial Start Date		2003-01-23

Registered in ClinicalTrials.gov		NCT00054223

Date Submitted to PDQ		2002-12-23

Information Last Verified		2006-09-28

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.