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

Special Category: NIH Clinical Center trial

Objectives

1. Determine the range of personality traits of patients enrolled in a phase I clinical trial.
2. Determine these patients' understanding of their medical situation and prognosis.
3. Determine these patients' understanding of risks and benefits of phase I clinical trials.
4. Determine these patients' reasons for participating in a phase I clinical trial.
5. Determine the risk/benefit trade-offs of these patients.
6. Determine the existential outlook of these patients.
7. 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

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

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

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