Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054223
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2003-02-05
Brief Title:
Study of Decision Making in Patients Participating in Phase I Clinical Trials
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 riskbenefit 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
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 riskbenefit 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000269911 | None | None | None |
| 03-CC-0063 | None | None | None |