Symptom Inventory for Gastrointestinal Stromal Tumors



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/24/2018
Start Date:July 2010
End Date:July 2020

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Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)

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.

Inclusion Criteria:

1. 18 years of age or older (Patient and family caregiver only)

2. Ability to speak and read English (All participants)

3. Residing where IVR service is available (Part 3, Patient only)

4. Diagnosis of GIST confirmed by pathological analysis (Patient only)

5. Starting new treatment (either surgical or medical) and planning to be followed at
M.D. Anderson Cancer Center (Part 3, Patient only)

6. Written consent to participate (All participants)

7. At least 3 months from start of initial treatment (surgical or medical) for GIST (Part
2, Patient only)

8. Family caregiver also willing to receive packet for expert panel participation (Part
2, Patient only)

9. Physician or nurse with at least 5 years experience caring for patients with GIST
(Professional expert only)

10. At least one publication in the last 5 years dealing with GIST (Physician professional
expert only)

11. Identification as a family caregiver by a patient with GIST (Family caregiver only)

12. Patient also willing to receive packet for expert panel participation (Family
caregiver only)

Exclusion Criteria:

1. Medical condition or impaired performance status that would preclude participation in
the study (Patient only)

2. Diagnosis of active psychosis or severe cognitive impairment as determined by primary
physician (Patient only)

3. Active treatment (systemic drug therapy or radiation therapy) for a second malignancy
(Patient only)
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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