Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043030
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2002-08-05
Brief Title:
Evaluating Patient Participation 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:
Survey Of Patients Motivations Perceptions And Expectations In Phase I Clinical Trials
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 Understanding why patients participate in a phase I clinical trial may help doctors plan better treatment for cancer
PURPOSE This clinical trial is studying to determine the reasons for participation perceptions and expectations of patients receiving treatment for cancer in phase I clinical trials
PURPOSE This clinical trial is studying to determine the reasons for participation perceptions and expectations of patients receiving treatment for cancer in phase I clinical trials
Detailed Description:
OBJECTIVES
Describe the motivations perceptions and expectations of patients enrolled in a phase I clinical trial
Assess the influence of age education and gender upon the perception of these patients
Compare the difference in perceptions motivations and expectations of patients who have previously participated in a phase I clinical trial vs those who have not
Determine whether patients perceptions motivations and expectations change while enrolled in a phase I clinical trial
Validate an interviewer-administered tool measuring the perceptions motivations and expectations of these patients
Assess patients perception of the information they were given while enrolled in a phase I clinical trial
OUTLINE Patients are interviewed over the phone to evaluate their perceptions motivations and expectations of phase I clinical trials Patients complete a questionnaire comprising 24 questions over 30-45 minutes Interviews are conducted within 1 week after enrolling in a phase I clinical trial prior to the first dose of study agent and then again 2 months later or at the time the patient stops treatment The first 10 patients enrolled complete an additional 6 questions over 15 minutes during the first interview to validate the questionnaire but do not complete a second interview
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study within 1 year
Describe the motivations perceptions and expectations of patients enrolled in a phase I clinical trial
Assess the influence of age education and gender upon the perception of these patients
Compare the difference in perceptions motivations and expectations of patients who have previously participated in a phase I clinical trial vs those who have not
Determine whether patients perceptions motivations and expectations change while enrolled in a phase I clinical trial
Validate an interviewer-administered tool measuring the perceptions motivations and expectations of these patients
Assess patients perception of the information they were given while enrolled in a phase I clinical trial
OUTLINE Patients are interviewed over the phone to evaluate their perceptions motivations and expectations of phase I clinical trials Patients complete a questionnaire comprising 24 questions over 30-45 minutes Interviews are conducted within 1 week after enrolling in a phase I clinical trial prior to the first dose of study agent and then again 2 months later or at the time the patient stops treatment The first 10 patients enrolled complete an additional 6 questions over 15 minutes during the first interview to validate the questionnaire but do not complete a second interview
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000069497 | None | None | None |
| 02-C-0204 | None | None | None |