Symptom Inventory for Gastrointestinal Stromal Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01178307
First received: August 6, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Gastrointestinal Stromal Tumors
Behavioral: Questionnaires
Behavioral: Interview
Behavioral: MDASI-GIST Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptom Burden in Patients With Gastrointestinal Stromal Tumors (GISTs)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 188
Study Start Date: July 2010
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Part 1
Patient interview and developmental questionnaires
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.
Part 2
Content Expert Panel (doctors, nurses) + Patients and Caregivers Questionnaire Development
Behavioral: Questionnaires
10 minutes to complete 3 questionnaires for development of MDASI-GIST
Other Name: survey
Part 3
Patient MDASI-GIST Questionnaire
Behavioral: MDASI-GIST Questionnaire
Every 4 weeks for one year
Other Name: survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178307

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis
Investigators
Principal Investigator: Loretta A. Williams, PhD, MSN UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01178307     History of Changes
Other Study ID Numbers: 2010-0267
Study First Received: August 6, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
GI cancers
GIST
Symptom Severity
Quality of Life
Questionnaire
M.D. Anderson Symptom Inventory
MDASI-GIST
patient-reported outcomes

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 21, 2013