Trials / Completed
CompletedNCT00054223
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- National Institutes of Health Clinical Center (CC) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | psychosocial assessment and care |
Timeline
- Start date
- 2003-01-01
- Completion
- 2005-11-01
- First posted
- 2003-02-06
- Last updated
- 2012-03-16
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00054223. Inclusion in this directory is not an endorsement.