A Randomized Clinical Trial of the Efficacy of an Interactive Voice Response System (IVRS) for Managing Symptoms of Patients Following Thoracic Surgery
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 patient's doctor by e-mail,
fax, or pager. All patients are encouraged to report and discuss any severe symptoms to your
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
To study the effectiveness of the interactive voice response system (IVRS), which is designed to send a report to a patient's doctor about severe symptoms they are experiencing.
Xin Shelley Wang, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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