Study of Decision Making in Patients Participating in Phase I Clinical Trials
NCT ID: NCT00054223
Last Updated: 2012-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2003-01-31
2005-11-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NONE
Interventions
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psychosocial assessment and care
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health Clinical Center (CC)
NIH
Principal Investigators
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Manish Agrawal, MD
Role: STUDY_CHAIR
National Cancer Institute (NCI)
Locations
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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
Countries
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Other Identifiers
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03-CC-0063
Identifier Type: -
Identifier Source: secondary_id
CDR0000269911
Identifier Type: -
Identifier Source: secondary_id
030063
Identifier Type: -
Identifier Source: org_study_id
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