Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423436
Status:
COMPLETED
Last Update Posted:
2011-12-16
First Post:
2007-01-16
Brief Title:
Interactive Voice Response IVR Symptom Assessment in Non-Small Cell Lung Cancer NSCLC Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Using an Interactive Voice Response Telephone System in the Assessment and Management of Symptoms in Advanced Lung Cancer Patients Receiving Chemotherapy
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 compare the effectiveness of an interactive voice response IVR telephone triagefeedback system versus an interactive voice response telephone system with assessment only in monitoring and managing symptoms in patients with advanced non small cell lung cancer NSCLC
To compare differences in mood and quality of life variables of patients using the IVR triagefeedback system versus IVR assessment only
To compare the healthcare utilization emergency visits admissions length of stay for hospitalizations for uncontrolled symptoms of patients using the IVR triagefeedback system versus IVR assessment only
To compare the effectiveness of an interactive voice response IVR telephone triagefeedback system versus an interactive voice response telephone system with assessment only in monitoring and managing symptoms in patients with advanced non small cell lung cancer NSCLC
To compare differences in mood and quality of life variables of patients using the IVR triagefeedback system versus IVR assessment only
To compare the healthcare utilization emergency visits admissions length of stay for hospitalizations for uncontrolled symptoms of patients using the IVR triagefeedback system versus IVR assessment only
Detailed Description:
You will be asked to complete several questionnaires during a visit to the Thoracic Clinic These questionnaires measure physical and emotional symptoms and quality of life Completing the questionnaires takes about 30-45 minutes The research nurse will also teach you how to use the telephone system for reporting symptoms You will tell the research nurse when the most convenient times for the telephone calls and the telephone system will be set up to call at those times
It is not clear at this time whether the telephone symptom evaluation is better than the usual plan that doctors and nurses follow for asking about symptoms For this reason you will be randomly picked as in the toss of a coin to be in one of two groups The chance of being in either one of the two programs is about equal
Half of the patients will be assigned to the telephone assessment system plus triage group If you are assigned to this group you will report symptoms to the telephone system and the doctor or nurse at MD Anderson will be notified when a symptom is severe You will also be encouraged to report all symptoms to their doctor and nurse at MD Anderson
Half of the patients will be assigned to the telephone assessment only group If you are assigned to this group your symptom information will only be given through the telephone system You will also be encouraged to report all symptoms directly to your doctor and nurse at MD Anderson Your physician may request information from the telephone system
If you are assigned to this telephone assessment only group the telephone system will call you twice a week during 2 cycles of chemotherapy It is programmed to ask you to rate your symptoms and how much the symptoms interfere in your life Rating symptoms using the telephone system takes less than five minutes for each call
After each chemotherapy cycle you and patients in both groups will be asked to fill out questionnaires during a clinic visit The questionnaires are used to measure emotional symptoms and quality of life Completing the questionnaires takes about 15-30 minutes Your medical charts will also be reviewed and information collected about medical history
If you have agreed to participate in the companion caregiver study the study staff will use your demographic and clinical data to study the influence of your symptoms on your caregivers physical and mental health
This is an investigational study About 100 will be enrolled at MD Anderson Cancer Center A total of 136 patients will take part in this multicenter study
It is not clear at this time whether the telephone symptom evaluation is better than the usual plan that doctors and nurses follow for asking about symptoms For this reason you will be randomly picked as in the toss of a coin to be in one of two groups The chance of being in either one of the two programs is about equal
Half of the patients will be assigned to the telephone assessment system plus triage group If you are assigned to this group you will report symptoms to the telephone system and the doctor or nurse at MD Anderson will be notified when a symptom is severe You will also be encouraged to report all symptoms to their doctor and nurse at MD Anderson
Half of the patients will be assigned to the telephone assessment only group If you are assigned to this group your symptom information will only be given through the telephone system You will also be encouraged to report all symptoms directly to your doctor and nurse at MD Anderson Your physician may request information from the telephone system
If you are assigned to this telephone assessment only group the telephone system will call you twice a week during 2 cycles of chemotherapy It is programmed to ask you to rate your symptoms and how much the symptoms interfere in your life Rating symptoms using the telephone system takes less than five minutes for each call
After each chemotherapy cycle you and patients in both groups will be asked to fill out questionnaires during a clinic visit The questionnaires are used to measure emotional symptoms and quality of life Completing the questionnaires takes about 15-30 minutes Your medical charts will also be reviewed and information collected about medical history
If you have agreed to participate in the companion caregiver study the study staff will use your demographic and clinical data to study the influence of your symptoms on your caregivers physical and mental health
This is an investigational study About 100 will be enrolled at MD Anderson Cancer Center A total of 136 patients will take part in this multicenter study
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