Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036829
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2002-05-13
Brief Title:
Improving Pain Management in Patients With Nonhematologic Cancer
Sponsor:
Inflexxion Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Improving Pain Management in Cancer Care
Status:
COMPLETED
Status Verified Date:
2003-03
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 A pain assessment and management system for people with cancer may help doctors accurately assess and plan more effective pain treatment for patients who have cancer
PURPOSE Clinical trial to determine the effectiveness of a pain assessment and management system in improving pain management in patients who have nonhematologic cancer
PURPOSE Clinical trial to determine the effectiveness of a pain assessment and management system in improving pain management in patients who have nonhematologic cancer
Detailed Description:
OBJECTIVES
Develop and test a pain assessment and management system for people with cancer PAMS-PC
Obtain feedback from patients with non-hematologic malignancies on the proposed features of the system and its usability and effectiveness
OUTLINE This is a multicenter study The study contains 3 parts Patients in part II are assigned to 1 of 2 assessment groups
Part I Patients participate in a focus interview by telephone over approximately 45 minutes The interview includes discussion of beliefs and concerns regarding pain and its management strategies used by the patient for managing pain the features of the proposed pain assessment and management system for people with cancer PAMS-PC and reactions of the patients to each proposed component of the system
Part II
Group A Patients participate in an assessment session over approximately 90 minutes comprising completion of a questionnaire followed by use of a test version of the PAMS-PC
Group B Patients use the PAMS-PC first followed by completion of the questionnaire
Thirty patients are then randomly selected from the 2 groups to repeat use of the PAMS-PC 3 hours after the initial assessment
Part III Patients participate in a patient acceptance test over 30-60 minutes in which patients test the demo version of the system complete an evaluation questionnaire and provide feedback by telephone
PROJECTED ACCRUAL A total of 180 patients 10 for part I 150 75 per group for part II and 20 for part III will be accrued for this study
Develop and test a pain assessment and management system for people with cancer PAMS-PC
Obtain feedback from patients with non-hematologic malignancies on the proposed features of the system and its usability and effectiveness
OUTLINE This is a multicenter study The study contains 3 parts Patients in part II are assigned to 1 of 2 assessment groups
Part I Patients participate in a focus interview by telephone over approximately 45 minutes The interview includes discussion of beliefs and concerns regarding pain and its management strategies used by the patient for managing pain the features of the proposed pain assessment and management system for people with cancer PAMS-PC and reactions of the patients to each proposed component of the system
Part II
Group A Patients participate in an assessment session over approximately 90 minutes comprising completion of a questionnaire followed by use of a test version of the PAMS-PC
Group B Patients use the PAMS-PC first followed by completion of the questionnaire
Thirty patients are then randomly selected from the 2 groups to repeat use of the PAMS-PC 3 hours after the initial assessment
Part III Patients participate in a patient acceptance test over 30-60 minutes in which patients test the demo version of the system complete an evaluation questionnaire and provide feedback by telephone
PROJECTED ACCRUAL A total of 180 patients 10 for part I 150 75 per group for part II and 20 for part III will be accrued for this study
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 |
|---|---|---|---|
| NCI-V02-1698 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069327 | REGISTRY | None | None |