Trial Information

Symptom Assessment in Advanced Cancer Patients Using an Interactive Voice Response (IVR) System

If you and your caregiver agree to take part in this study, you will be randomly assigned
(as in the toss of the coin) to be in 1 of 2 groups. Group A will receive standard of care
provided at the palliative center at M. D. Anderson, but will not receive any phone calls
from the Interactive Voice Response (IVR) system. Group B will receive phone calls by the
Interactive Voice Response (IVR) system on Monday, Wednesday, and Friday for 15 days.

Once you sign this consent form, you will answer questions about your diagnosis, the
medication that you take, and the symptoms that you are having (for example, pain, fatigue,
anxiety, depression, and overall feeling of well-being). You will either be asked these
questions verbally or you will complete a written questionnaire. This should take about 30
minutes to complete.

If you and your caregiver are assigned to Group A, you will continue with the standard of
care provided at the palliative center at M. D. Anderson. On Day 15, both you and your
caregiver will be seen in the outpatient clinic by the research nurse, and complete the same
questionnaire you had at the beginning of the study, either verbally or written. This
should take about 30 minutes to complete.

If you and your caregiver are assigned to Group B, a research nurse will train you and your
caregiver to operate the IVR system. The IVR call will be made to the preferred telephone
number(s) provided by you and your caregiver. The telephone calls will be made 1 time a day
at times chosen by you and your caregiver. You will both be given a 3-digit code number to
enter as a way of confirming who you are.

Once you have entered the requested numbers, the IVR system will ask you to answer
questions about pain, fatigue, anxiety, depression, and your overall feeling of well-being.
These phone calls should take about 3-5 minutes to complete. You should complete the phone
calls separately and should not attempt to influence each others answers.

A research nurse will review the answer in the IVR system. If you haven't responded to the
IVR questions in 3 days, if you answer that you would like to be contacted by a nurse, or if
a symptom has reached a concerning level, you and your caregiver will receive a phone call
from the nurse. The nurse may ask about symptoms, medications being taken, concerns or
doubts about the medication, and if you have any concerns about your physical or emotional
well being. You will be reminded of the different telephone numbers you can use to receive
assistance 24 hours a day. During the phone call, you will also be asked if you would like
the nurse to contact your caregiver for information and support. If you agree, the nurse
will contact your caregiver.

On Day 8, both you and your caregiver will be contacted either in person or by phone by the
research nurse and will complete the same questionnaire you had at the beginning of the
study. On Day 15, both you and your caregiver will be seen in the outpatient clinic by the
research nurse and will complete this same questionnaire again, either verbally or written.
This should take about 30 minutes to complete each time.

Your participation on this study will end on Day 15.

This is an investigational study. Up to 68 patient-caregiver groups (or a total of 136
participants) will take part in this study. All the participants will be enrolled at M. D.
Anderson.