Study of Decision Making in Patients Participating in Phase I Clinical Trials
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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||Phase|
|Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific||Procedure: psychosocial assessment and care||Not Applicable|
- 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|
|Actual Study Completion Date :||November 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|