Symptom Inventory for Gastrointestinal Stromal Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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:
- 18 years of age or older (Patient and family caregiver only)
- Ability to speak and read English (All participants)
- Residing where IVR service is available (Part 3, Patient only)
- Diagnosis of GIST confirmed by pathological analysis (Patient only)
- Starting new treatment (either surgical or medical) and planning to be followed at M.D. Anderson Cancer Center (Part 3, Patient only)
- Written consent to participate (All participants)
- At least 3 months from start of initial treatment (surgical or medical) for GIST (Part 2, Patient only)
- Family caregiver also willing to receive packet for expert panel participation (Part 2, Patient only)
- Physician or nurse with at least 5 years experience caring for patients with GIST (Professional expert only)
- At least one publication in the last 5 years dealing with GIST (Physician professional expert only)
- Identification as a family caregiver by a patient with GIST (Family caregiver only)
- Patient also willing to receive packet for expert panel participation (Family caregiver only)
Exclusion Criteria:
- Medical condition or impaired performance status that would preclude participation in the study (Patient only)
- Diagnosis of active psychosis or severe cognitive impairment as determined by primary physician (Patient only)
- 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