Interactive Voice Response System (IVRS) for Managing Symptoms of Patients Following Thoracic Surgery
NCT ID: NCT00505024
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2006-07-31
2010-06-30
Brief Summary
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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
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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 them.This 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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IVRS Only
Interactive Voice Response System
Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to 10.
IVRS + Symptoms Report
Interactive Voice Response System
Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to 10.
Symptoms Report
A report of severe symptoms will be sent to your doctor or nurse.
Interventions
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Interactive Voice Response System
Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to 10.
Symptoms Report
A report of severe symptoms will be sent to your doctor or nurse.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients 18 years of age or older
3. Men and women of all ethnic groups who are English-speaking, and
4. Patients residing in the United States. (The IVR system is not yet available in other languages. The United States residency requirement (MDACC is an international referral center) will allow us to follow patients for the duration of the study.)
Exclusion Criteria
2. Patients who have difficulty understanding the intent of the study
3. Patients who cannot complete the assessment tools independently
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Xin Shelley Wang, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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The University of Texas M.D.Anderson Cancer Center
Other Identifiers
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2006-0299
Identifier Type: -
Identifier Source: org_study_id