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Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)

18 Years
Open (Enrolling)
Gastrointestinal Stromal Tumors

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Trial Information

Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)

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

Additional Information:

The questionnaires will only use your study number and will not have your name linked to
them. All questionnaires and study data will be kept in a locked cabinet at all times. All
study materials will be destroyed after data analysis is completed and study results

Information about your symptoms collected in this study is collected for research purposes
only. If you are experiencing severe or troublesome symptoms, you should report them to your
doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data
collector notices that you have rated a symptom as severe, the data collector will ask you
if your doctor or nurse is aware of the symptom or if you intend to report the symptom to
your doctor or nurse. If you have not or do not intend to report the symptom, the data
collector will let you know that he or she will report the symptom to your doctor or nurse.

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)

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Questionnaire Responses to Symptom Inventory for Gastrointestinal Stromal Tumors

Outcome Description:

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.

Outcome Time Frame:

Patients will be followed on study for 1 year regardless of changes in disease stage or treatments.

Safety Issue:


Principal Investigator

Loretta A. Williams, PhD, MSN

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • GI cancers
  • GIST
  • Symptom Severity
  • Quality of Life
  • Questionnaire
  • M.D. Anderson Symptom Inventory
  • patient-reported outcomes
  • Gastrointestinal Stromal Tumors



UT MD Anderson Cancer CenterHouston, Texas  77030