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

Not Applicable

Completed

• Conditions: Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00054223
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted.

PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and risks and benefits of participating in a phase I trial.

Detailed Description

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.

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.

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

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Study Completion: 2005-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 🇺🇸 Chicago, Illinois, United States

Fox Chase Cancer Center - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States

Cancer Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States

M. D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States