Study of Decision Making in Patients Participating in Phase I Clinical Trials
|ClinicalTrials.gov Identifier: NCT00054223|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : March 16, 2012
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.
|Condition or disease||Intervention/treatment|
|Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific||Procedure: psychosocial assessment and care|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Masking:||None (Open Label)|
|Official Title:||Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients|
|Study Start Date :||January 2003|
|Study Completion Date :||November 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054223
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892|
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Cancer Therapy and Research Center|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Manish Agrawal, MD||National Cancer Institute (NCI)|