- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00054223
Study of Decision Making in Patients Participating in Phase I Clinical Trials
Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center - Philadelphia
-
-
Texas
-
Houston, Texas, United States, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
-
San Antonio, Texas, United States, 78229
- Cancer Therapy and Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Consented to enrollment in a phase I cancer clinical trial
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
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
Study Plan
How is the study designed?
Design Details
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Manish Agrawal, MD, National Cancer Institute (NCI)
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 030063
- 03-CC-0063
- CDR0000269911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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