An observational study in Gastrointestinal Stromal Tumors, sponsored by M.D. Anderson Cancer Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by M.D. Anderson Cancer Center · Observational
The goal of this research study is to better understand the symptoms experienced by patients with GIST.
There are 3 parts to this study. In Part 1, participants will complete 1 set of interviews and questionnaires about GIST symptoms. In Part 2, the importance of some symptoms to patients with GIST will be rated by doctors, nurses, patients, and family caregivers. In Part 3, participants will complete questionnaires about GIST symptoms over 1 year.
You are being asked to take part in Part 3 of the study.
Symptom Questionnaires:
If you agree to take part in this study, you will complete questionnaires about symptoms you are having. You will be asked to fill these out 1 time a week during the first 2 months after surgery, 1 time a week during the first 3 months of a new therapy, and every 2 weeks at other times. The questionnaire will ask you to rate how severe your symptoms are and how the symptoms effect the activities of your daily life. The symptom questionnaire should take about 5 minutes to complete. You will complete the questionnaire during the first study visit and at your regular clinic visits.
Between clinic visits, you will be called every 1-2 weeks to complete the questionnaire using an automated telephone system. You can decide what time is most convenient for the automated phone system to call you. If you are not available when the automated system calls, it will call you again at a later time. If you are not reached by the automated phone system after several tries, the study staff will call you. You will be given a secure user name and identification number to use with the automated phone system. The study staff will teach you how to use the automated phone system.
At the clinic visit closest to 3 months after you start the study, you may be seen by a research staff member a second time 1 to 3 days after you completed the symptom questionnaire and asked to fill out the symptom questionnaire again. The research staff member may contact you by phone prior to this clinic visit to arrange times to meet you for the 2 assessments.
Quality-of-Life/Demographic Questionnaires:
At the first visit and the regular clinic visits, you will also rate your overall quality-of-life. This should take about 1 minute to complete.
At the first visit, you will also be asked some demographic questions (such as your age and marital status). Answering these questions should take about 1 minute.
Opinion Questionnaire:
If you are 1 of the first 40 patients enrolled in the study, you will be asked questions about your opinion of the symptom questionnaire at the clinic visit closest to 3 months after you start the study. For example, you will be asked if the symptom questionnaire was easy to understand and complete, and if there were any other questions that should be included. The study staff will use your opinion to decide if changes should be made to the questionnaire or if important symptom questions are missing from the questionnaire. This questionnaire should take about 5 minutes to complete.
Length of Study:
You will be on study for 1 year. You will be off study after you complete the last symptom questionnaire.
This is an investigational study.
Up to 188 participants will take part in this study. Up to 150 participants will be enrolled in Part 3 of this study. All will be enrolled at MD Anderson.
333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.
This study's enrollment of 187 is above the median of 116 across 68 observational studies indexed under Gastrointestinal Stromal Tumors.
Browse Gastrointestinal Stromal Tumors 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.
UT MD Anderson Cancer Center Sarcoma and Surgical Oncology Clinics GIST Patients, their caregivers, doctors and nurses who are 18 years or older.
Exclusion Criteria:
Patient interview and developmental questionnaires
Behavioral: Questionnaires · Behavioral: Interview
Content Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development
Behavioral: Questionnaires
Patient MDASI-GIST Questionnaire
Behavioral: MDASI-GIST Questionnaire
10 minutes to complete 3 questionnaires for development of MDASI-GIST
Also known as: survey
Each interview will take approximately 30 minutes.
Every 4 weeks for one year
Also known as: survey
Questionnaire Responses to Symptom Inventory for Gastrointestinal Stromal Tumors
Descriptive statistics used to assess the distributional characteristics and demographics of the study population and to report how patients rate symptom severity and interference with function.
Time frame: Patients will be followed on study for 1 year regardless of changes in disease stage or treatments.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Gastrointestinal Stromal Tumors→
M.D. Anderson Cancer Center