An interventional study of Questionnaire and Interview in Gastrointestinal Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-30.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Screening
The goal of this study is to learn more about the symptoms that may occur in patients with GI cancer. The types of GI cancer being studied are cancers of the stomach, liver, pancreas, colon, and rectum. Researchers want to test a newly-designed questionnaire called the M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) questionnaire.
Questionnaires:
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.
Interview:
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.
Information Collection:
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 184 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Questionnaire
Behavioral: Questionnaire · Other: Interview
Day 1 MDASI-GI Questionnaire
Open-ended, audiotaped interviews
Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response)
Time frame: 2 Years
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center