Trial Information

Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System

You will be asked to complete a form with some personal information. You will also be asked
to complete surveys that measure your mood and quality of life. You will be asked to
complete the symptom survey (the MD Anderson Symptom Inventory) that will ask you to rate
your symptoms and how much the symptoms interfere in your daily activities. Completing
these surveys takes about 20 minutes.

In order to understand symptoms that are specific to a particular cancer, cancer stage, or
treatment, the research staff may ask you questions about symptoms you have had since you
were diagnosed. The interviewer may ask follow-up questions to get more complete information
about your symptoms. Interviews are digitally recorded and then transcribed (written out in
text) later. Completing the interview along with other surveys takes about 45 minutes
total.

During your treatment, you may be asked to complete the symptom survey using the paper and
pencil method, or an electronic tablet, or you may be asked to complete it over the
telephone. If you are asked to use the phone method, we will use an interactive voice
response (IVR) telephone system to contact you to find out about symptoms you may be
experiencing. The research nurse will ask you for a convenient time for the system to call.

How often the system will call you during your treatment depends on the type of treatment
you are receiving. The research nurse will give you more information about the schedule of
calls to expect for the study and the times you will be asked to complete the mood and
quality of life surveys over the course of your treatment.

Information about your symptoms collected in this study is collected for research purposes
only. If you are experiencing severe or troublesome symptoms, you should report them to your
doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data
collector notices that you have rated a symptom as severe, the data collector will ask you
if your doctor or nurse is aware of the symptom or if you intend to report the symptom to
your doctor or nurse. If you have not or do not intend to report the symptom, the data
collector will let you know that he or she will report the symptom to your doctor or nurse.

This is an investigational study. Up to 2,450 participants will participate in this study.
Up to 2,100 will be enrolled at MD Anderson.