Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012896
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Improving Cancer Pain Management Using AHCPR Cancer Pain Guidelines
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Cancer Pain Management Using AHCPR Cancer Pain Guidelines
Status:
COMPLETED
Status Verified Date:
2007-02
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:
Cancer pain is a pervasive problem for the person with cancer Despite advances in knowledge effective cancer management is infrequently achieved While this problem is multi-factorial the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions
Detailed Description:
Background
Cancer pain is a pervasive problem for the person with cancer Despite advances in knowledge effective cancer management is infrequently achieved While this problem is multi-factorial the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions
Objectives
The primary objective of this study is to determine the effects of two nursing interventions on the improvement of pain management PM functional status FS and quality of life QOL in veterans receiving cancer care in VA ambulatory care clinics The two interventions will utilize selected cancer pain management strategies developed as Clinical Practice Guidelines by the Agency for Health Care Policy and Research AHCPR This study will test the hypothesis that those veterans in the intervention arms will have lower pain intensity scores greater pain relief and satisfaction with PM and will have higher QOL and FS scores specifically in the areas of physical and social functioning A secondary aim is to measure the extent that cancer PM is affected by the intervening variables of age affect attitudinal barriers veteran culture typestage of disease and type of cancer treatment
Methods
The design of this randomized trial has one between-subjects factor GROUP with three levels usual care structured education individualized coaching and one within-subjects factor TIME with two measures pre-test and post-test Patients with cancer pain n320 are randomly assigned to one of three groups after stratifications to control for the confounding variables of pain intensity and effects of cancer treatment Those in the structured education arm view a video on cancer pain management and receive the AHCPR patient pamphlet on cancer pain management Those subjects in the individualized coaching arm receive the same structured education as above but also partake in four telephone coaching sessions focusing on the individuals specific pain management problems The primary outcome variables measured after 12 weeks are satisfaction with pain management quality of life and functional status
Status
The project is in the final phase of data analysis and writing the final report A total of 322 subjects were recruited 289 eligible patients completed the Pre-test and 227 completed the Post-Test Two papers are approximately 75 written The main study paper is in the planning stage to be completed after the final report is submitted
Cancer pain is a pervasive problem for the person with cancer Despite advances in knowledge effective cancer management is infrequently achieved While this problem is multi-factorial the patient may have attitudinal barriers to effective pain management that can be ameliorated with novel interventions
Objectives
The primary objective of this study is to determine the effects of two nursing interventions on the improvement of pain management PM functional status FS and quality of life QOL in veterans receiving cancer care in VA ambulatory care clinics The two interventions will utilize selected cancer pain management strategies developed as Clinical Practice Guidelines by the Agency for Health Care Policy and Research AHCPR This study will test the hypothesis that those veterans in the intervention arms will have lower pain intensity scores greater pain relief and satisfaction with PM and will have higher QOL and FS scores specifically in the areas of physical and social functioning A secondary aim is to measure the extent that cancer PM is affected by the intervening variables of age affect attitudinal barriers veteran culture typestage of disease and type of cancer treatment
Methods
The design of this randomized trial has one between-subjects factor GROUP with three levels usual care structured education individualized coaching and one within-subjects factor TIME with two measures pre-test and post-test Patients with cancer pain n320 are randomly assigned to one of three groups after stratifications to control for the confounding variables of pain intensity and effects of cancer treatment Those in the structured education arm view a video on cancer pain management and receive the AHCPR patient pamphlet on cancer pain management Those subjects in the individualized coaching arm receive the same structured education as above but also partake in four telephone coaching sessions focusing on the individuals specific pain management problems The primary outcome variables measured after 12 weeks are satisfaction with pain management quality of life and functional status
Status
The project is in the final phase of data analysis and writing the final report A total of 322 subjects were recruited 289 eligible patients completed the Pre-test and 227 completed the Post-Test Two papers are approximately 75 written The main study paper is in the planning stage to be completed after the final report is submitted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None