Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501319
Status:
COMPLETED
Last Update Posted:
2011-11-08
First Post:
2007-07-12
Brief Title:
Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer NSCLC Patients Following Thoracic Surgery
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Longitudinal Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer NSCLC Patients Following Thoracic Surgery
Status:
COMPLETED
Status Verified Date:
2011-11
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:
Primary Objectives
To longitudinally assess the natural history of symptoms prevalence severity patterns of symptoms and the relationship of physical and psychological distress among post-thoracic surgery for non-small cell lung cancer patients with early stage stage I-IIIA disease
To determine crisis events when symptoms are most severe their relationship with cancer therapy surgical techniques and disease and their relationship with function and quality of life and to determine current practice patterns of symptom control throughout the six months of the post-surgical phase
To determine the utility of a weekly telephone-administered interactive voice response symptom assessment IVR-MDASI for identifying emergent clinically significant symptoms in this population
To develop symptom severity critical values and critical treatment algorithms for post-operative symptom control for NSCLC patients
To longitudinally assess the natural history of symptoms prevalence severity patterns of symptoms and the relationship of physical and psychological distress among post-thoracic surgery for non-small cell lung cancer patients with early stage stage I-IIIA disease
To determine crisis events when symptoms are most severe their relationship with cancer therapy surgical techniques and disease and their relationship with function and quality of life and to determine current practice patterns of symptom control throughout the six months of the post-surgical phase
To determine the utility of a weekly telephone-administered interactive voice response symptom assessment IVR-MDASI for identifying emergent clinically significant symptoms in this population
To develop symptom severity critical values and critical treatment algorithms for post-operative symptom control for NSCLC patients
Detailed Description:
Before surgery you will be asked to complete four surveys about your mood symptoms quality of life and smoking history Completing the questionnaires will take about 20 minutes You will be asked for some information about age sex race education marital status and employment status full-time part-time unemployed Before surgery the research nurse will teach you how to use the special telephone system called an Interactive Voice Response IVR telephone system This system is used for tracking symptoms at home An instruction pamphlet will also be given to you
Three days after surgery while you are in the hospital you will be asked by the research nurse to again complete one questionnaires that measures your symptoms
Once you are home from the hospital the automatic telephone IVR system will call at a prescheduled time that is convenient for you The phone call will take about four minutes to complete The IVR will call once a week for the first 3 months after surgery and then every two weeks for an additional 3 months
The research nurse will call you one week after surgery and then one month three months and six months to complete four questionnaires about symptoms mood quality of life and smoking history It will take about 20 minutes to complete the questionnaires
The information collected by the IVR is for research purposes only and you must report any symptoms that you are concerned about to your physicians or nurses
Should severe symptoms develop research staff will notify the your treatment team
This is an investigational study About 112 patients will participate in this study All will be enrolled at M D Anderson
Three days after surgery while you are in the hospital you will be asked by the research nurse to again complete one questionnaires that measures your symptoms
Once you are home from the hospital the automatic telephone IVR system will call at a prescheduled time that is convenient for you The phone call will take about four minutes to complete The IVR will call once a week for the first 3 months after surgery and then every two weeks for an additional 3 months
The research nurse will call you one week after surgery and then one month three months and six months to complete four questionnaires about symptoms mood quality of life and smoking history It will take about 20 minutes to complete the questionnaires
The information collected by the IVR is for research purposes only and you must report any symptoms that you are concerned about to your physicians or nurses
Should severe symptoms develop research staff will notify the your treatment team
This is an investigational study About 112 patients will participate in this study All will be enrolled at M D Anderson
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