M.D. Anderson Symptom Inventory (MDASI-GI) Validation and Clinical Utility in Patients With Gastrointestinal Cancers Being Treated or Followed by GI Medical Oncology
If you agree to take part in this study, you will be asked to complete the MDASI-GI
questionnaire on Day 1. It asks about any symptoms you may be experiencing, and how those
symptoms may be interfering with your daily life. You will also complete two
questionnaires that ask about the overall quality of your life. In total, these
questionnaires should take about 20 minutes to complete.
You will then complete a questionnaire that asks for demographic information such as your
age and marital status. It should take about 5 minutes.
You will receive another copy of the MDAS-GI questionnaire and the quality-of-life
questionnaire to take home and complete 1 week later. The research staff will call you to
remind you when it is time to complete this questionnaires. You should mail it back to the
study staff in a stamped, pre-addressed envelope that will be provided to you.
Evaluation of Questionnaires:
Also on Day 1, a small group of participants (25 out of the 185 total participants) will
complete an additional questionnaire called a "cognitive debriefing" questionnaire. These
25 participants will be the first 5 participants to join this study who have 1 of the 5
types of cancer being studied.
The questionnaire asks questions related to how easy it was for you to answer the questions
on the MDASI-GI questionnaire, whether the questions relate to the symptoms you may be
experiencing, and whether any other questions should be added. This questionnaire should
take about 10 minutes to complete.
Another small group of participants (a different 25 out of the 185 total) will have a
one-on-one interview with a member of the study staff. During the interview, you will be
asked to further describe the symptoms you may have experienced. This interview will be
scheduled for a day when you are going to be at M. D. Anderson for a routine clinic visit.
It should take about 30 minutes to complete.
You and the interviewer will be the only ones in the room during the interview, and the
information collected will be kept confidential. The interview will be tape-recorded.
Questionnaire and Interview Content:
Your responses will not be shared with your doctor. If you feel you need a doctor's opinion
about anything that is asked about, please contact your doctor.
As part of this research study, the research staff will collect information from your
medical record one time. This will include data about the cancer, cancer treatment, and
routine test results.
Length of Study Participation:
After you mail back the questionnaire at Week 1 (or complete it by phone interview with
research staff), or after the interview if you have one, your active participation in this
study will be over.
This is an investigational study. Up to 185 patients will take part in this study. All
will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response)
Xin Shelley Wang, MD, MPH
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|