Spots Global Cancer Trial Database for Study of Decision Making in Patients Participating in Phase I Clinical Trials
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Trial Identification
Brief Title: Study of Decision Making in Patients Participating in Phase I Clinical Trials
Official Title: Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients
Study ID: NCT00054223
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office, Bethesda, Maryland, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Cancer Therapy and Research Center, San Antonio, Texas, United States
Contact Details
Name: Manish Agrawal, MD
Affiliation: National Cancer Institute (NCI)
Role: STUDY_CHAIR
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