Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505024
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2007-07-18
Brief Title:
Interactive Voice Response System IVRS for Managing Symptoms of Patients Following Thoracic Surgery
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Clinical Trial of the Efficacy of an Interactive Voice Response System IVRS for Managing Symptoms of Patients Following Thoracic Surgery
Status:
COMPLETED
Status Verified Date:
2012-07
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:
To test the effectiveness of the interactive voice response telephone system with a triagefeedback component that incorporates timely symptom assessment feedback to physicians critical treatment guidelines for managing selected symptoms distress sleep disturbance shortness of breath constipation and pain in a cohort of cancer patients during the first month post-thoracic surgery
This interactive voice response system IVR will be evaluated in a randomized clinical trial with an intervention group IVR symptom assessment with triage and a control group IVR symptom assessment only
We hypotheses that
1 Patients in the MDASI-IVR plus triage group will have less symptom burden less symptom severity less symptom related interference and better satisfaction of symptom control better physical and emotional well-being over the month of the trial compared to the control group
2 Patients in the MDASI-IVR plus triage group will have more frequent documentation of symptom management in line with treatment guidelines compared to the control group
This interactive voice response system IVR will be evaluated in a randomized clinical trial with an intervention group IVR symptom assessment with triage and a control group IVR symptom assessment only
We hypotheses that
1 Patients in the MDASI-IVR plus triage group will have less symptom burden less symptom severity less symptom related interference and better satisfaction of symptom control better physical and emotional well-being over the month of the trial compared to the control group
2 Patients in the MDASI-IVR plus triage group will have more frequent documentation of symptom management in line with treatment guidelines compared to the control group
Detailed Description:
The IVRS is a special telephone system that calls patients and asks questions about symptoms The system can record and report severe symptoms to a patients doctor by e-mail fax or pager All patients are encouraged to report and discuss any severe symptoms to your treating clinicians
If you agree to take part in this study you will be randomly assigned as in the toss of a coin to 1 of 2 groups Participants in one group will complete symptom surveys on the IVRS Participants in the other group will complete symptom surveys on the IVRS and in addition a report of severe symptoms will be sent to their doctor or nurse
All participants will initially be asked to complete 2 surveys before surgery that will ask about any symptoms you may be having and your general quality of life It will take about 10 minutes to complete both surveys You will also be asked to provide some demographic information such as your age gender employment status and ethnicity
Before you are discharged from the hospital after your surgery a member of the study staff will visit you and teach you how to use the IVRS system and you will then continue participation according to your assigned group
After you are discharged from the hospital the system will be set up to call you all participants twice a week until 1 month after your surgery It will be automated to ask you to rate 14 types of symptoms such as pain fatigue nausea sleep disturbance and 6 other items such as how your symptoms interfere with your day-to-day activity mood and enjoyment of life on a scale from 0 to 10 Zero 0 means that the symptom is not present and 10 means that you are experiencing the symptom at its worst The call should last from 3-5 minutes For participants in the other group a symptom report will also be sent to your doctor or nurse
One month after surgery you will have a phone call from a member of the research staff During this phone call you will be asked to provide additional information about the symptoms you experienced and how you managed themThis phone call will last about 20 minutes If you are not able to be reached by research staff the first time you are called you will be called again at another time between the 5th and 6th week after your surgery
THIS IS AN INVESTIGATIONAL STUDY Up to 130 patients 65 in each group will take part in this study All will be enrolled at M D Anderson
If you agree to take part in this study you will be randomly assigned as in the toss of a coin to 1 of 2 groups Participants in one group will complete symptom surveys on the IVRS Participants in the other group will complete symptom surveys on the IVRS and in addition a report of severe symptoms will be sent to their doctor or nurse
All participants will initially be asked to complete 2 surveys before surgery that will ask about any symptoms you may be having and your general quality of life It will take about 10 minutes to complete both surveys You will also be asked to provide some demographic information such as your age gender employment status and ethnicity
Before you are discharged from the hospital after your surgery a member of the study staff will visit you and teach you how to use the IVRS system and you will then continue participation according to your assigned group
After you are discharged from the hospital the system will be set up to call you all participants twice a week until 1 month after your surgery It will be automated to ask you to rate 14 types of symptoms such as pain fatigue nausea sleep disturbance and 6 other items such as how your symptoms interfere with your day-to-day activity mood and enjoyment of life on a scale from 0 to 10 Zero 0 means that the symptom is not present and 10 means that you are experiencing the symptom at its worst The call should last from 3-5 minutes For participants in the other group a symptom report will also be sent to your doctor or nurse
One month after surgery you will have a phone call from a member of the research staff During this phone call you will be asked to provide additional information about the symptoms you experienced and how you managed themThis phone call will last about 20 minutes If you are not able to be reached by research staff the first time you are called you will be called again at another time between the 5th and 6th week after your surgery
THIS IS AN INVESTIGATIONAL STUDY Up to 130 patients 65 in each group will take part 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