Solid Tumors Clinical Trial
Official title:
Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
The scientific aim of this study is to evaluate patient comprehension of the 77 newly
developed items as well as the extent to which the items correspond to the concepts of
interest for each patient reported outcome (PRO).
A secondary aim of this study is to evaluate the usability of the technology interface for
collecting the PRO data of the PRO-CTCAE system once it has been built to accommodate the
learning garnered during the cognitive interviews.
Screening:
The study staff will talk to your doctor or nurse, and/or look at your medical record, to
see if you are currently receiving treatment. The study staff will also look at your medical
record to see if you have any future clinic visits at M. D. Anderson. This is the first step
of "screening" to help the researchers decide if you are eligible to take part in this
study.
If you are found to be possibly eligible to take part in this study based on the first step
of screening, the second step of screening will occur:
At your clinic visit, the study staff will talk to you about this study. You will be asked
questions about school, which should take about 2 minutes.
Study Visit If you are found to be eligible and you agree to take part in this study, you
will look at a list of 34 cancer symptoms if you are a male or a list of 36 cancer symptoms
if you are a female. You will fill out a questionnaire that asks you to mark each symptom
that you may be experiencing at this time, and other information about the symptoms such as
how often they occur.
After you complete the questionnaire, you will be interviewed by the study staff about how
you answered some of the questions. For example, you will be asked if the words describing
the symptoms were easy to understand or if other words may be more clear.
There are no right or wrong answers to any part of this study. Researchers are interested in
your thoughts about the words.
Filling out the questionnaire will take about 10-15 minutes. The interview will take about
20-30 minutes.
Study Data:
The interview will be audio-recorded. Only the study staff will hear the recording. The
recording will be saved on a password-protected computer that can only be accessed by the
study staff.
Your responses will be coded without using your name or other personal identifying
information. Only the study staff will have access to the code numbers and be able to
identify you.
Your responses will not be shared with your doctor without your consent.
In some of the questions, you will be asked about your feelings (for example, whether you
feel unhappy or anxious). If your responses show that you may be having emotional
difficulties, you will be given a list of community agencies that provide services for
emotional issues. You may also speak to your doctor about your feelings.
Length of Study:
After the study visit, your active participation will be over. In some cases, the study
staff may call you to ask that you clarify some of your answers. Your medical record may
also be checked to confirm the cancer diagnosis and your treatments.
This is an investigational study. Up to 100 patients will take part in this study. Up to 20
will be enrolled at M. D. Anderson.
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Observational Model: Case-Only, Time Perspective: Prospective
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