Symptom Inventory for Gastrointestinal Stromal Tumors

• ClinicalTrials.gov Identifier: NCT01178307
• Recruitment Status: Unknown
• First Posted: August 10, 2010
• Last Update Posted: January 13, 2020
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: Novartis
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: August 6, 2010
• First Posted Date: August 10, 2010
• Last Update Posted Date: January 13, 2020
• Actual Study Start Date: July 29, 2010
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2010)

Questionnaire Responses to Symptom Inventory for Gastrointestinal Stromal Tumors [ Time Frame: Patients will be followed on study for 1 year regardless of changes in disease stage or treatments. ]

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Symptom Inventory for Gastrointestinal Stromal Tumors
• Official Title: Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)

Brief Summary

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.

Detailed Description

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: UT MD Anderson Cancer Center Sarcoma and Surgical Oncology Clinics GIST Patients, their caregivers, doctors and nurses who are 18 years or older.
• Condition: Gastrointestinal Stromal Tumors

Intervention

• Behavioral: Questionnaires
  10 minutes to complete 3 questionnaires for development of MDASI-GIST
  Other Name: survey
• Behavioral: Interview
  Each interview will take approximately 30 minutes.
• Behavioral: MDASI-GIST Questionnaire
  Every 4 weeks for one year
  Other Name: survey

Study Groups/Cohorts

• Part 1
  Patient interview and developmental questionnaires
  Interventions:

  • Behavioral: Questionnaires
  • Behavioral: Interview
• Part 2
  Content Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development
  Intervention: Behavioral: Questionnaires
• Part 3
  Patient MDASI-GIST Questionnaire
  Intervention: Behavioral: MDASI-GIST Questionnaire

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: January 9, 2020): 187
• Original Estimated Enrollment (submitted: August 9, 2010): 188
• Estimated Study Completion Date: July 31, 2020
• Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01178307
• Other Study ID Numbers: 2010-0267
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Loretta A. Williams, PhD, MSN / Assistant Professor, UT MD Anderson Cancer Center
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: Novartis

Investigators

• Principal Investigator: Loretta A. Williams, PhD, MSN; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: January 2020