Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006253
Status:
COMPLETED
Last Update Posted:
2011-12-07
First Post:
2000-09-11
Brief Title:
Pain and Fatigue Study
Sponsor:
Michigan State University
Organization:
Michigan State University
Study Overview
Official Title:
Family Home Care for Cancer - A Community-Based Model
Status:
COMPLETED
Status Verified Date:
2011-12
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:
Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week 6-contact self management attention control SMAC intervention or to a 8-week 6-contact experimental patient intervention for management of symptoms and support PIMSS targeted toward symptom management reducing impact on physical role and social functioning and emotional distress Both groups will continue to receive conventional cancer care
When compared with the self-management attention control intervention patients exposed to the experimental intervention will report statistically significant positive effects on the following
1 The primary outcome--total number of symptoms reported
2 The secondary patient outcomes--reduced deterioration in physical role impact and social functioning emotional distress levels of communication with caregiver about care and communication and satisfaction with provider care and
3 Caregiver outcomes--greater involvement in symptom management increased mastery of the caregiving process reduced levels of depression and burden
When compared with the self-management attention control intervention patients exposed to the experimental intervention will report statistically significant positive effects on the following
1 The primary outcome--total number of symptoms reported
2 The secondary patient outcomes--reduced deterioration in physical role impact and social functioning emotional distress levels of communication with caregiver about care and communication and satisfaction with provider care and
3 Caregiver outcomes--greater involvement in symptom management increased mastery of the caregiving process reduced levels of depression and burden
Detailed Description:
GOAL The primary goal of this research is to test a symptom management intervention delivered by nurses with special training using a stepped-care approach targeted toward pain and fatigue followed by fifteen other prevalent cancer symptoms Second goals are to improve physical and social functioning lower emotional distress and improve communication with family caregiver in symptom management and assist them to reduce their levels of depression and burden This research is funded through a grant from the National Cancer Institutes and builds upon the Family Care Research Teams program of supportive cancer-care research
OUTCOMES This study tests a stepped-approach intervention to determine if it improves symptom outcomes especially pain and fatigue Secondary outcomes addressed by the intervention are physical role impact social functioning and emotional distress These outcomes can have significant impact on patients and family caregivers well-being as patients undergo chemotherapy The shorter more intense intervention corresponds to changes int he clinical management of cancer patient with more intense shorter chemotherapy treatments therefore this intervention will be more easily translatable to the clinical setting
OUTCOMES This study tests a stepped-approach intervention to determine if it improves symptom outcomes especially pain and fatigue Secondary outcomes addressed by the intervention are physical role impact social functioning and emotional distress These outcomes can have significant impact on patients and family caregivers well-being as patients undergo chemotherapy The shorter more intense intervention corresponds to changes int he clinical management of cancer patient with more intense shorter chemotherapy treatments therefore this intervention will be more easily translatable to the clinical setting
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