Development of the MDASI-Spine Tumor Module
The goal of this research study is to learn the severity of certain symptoms in patients with tumors of the spine or spinal cord. Researchers also want to learn if the M. D. Anderson Symptom Inventory-Spine is a good way to rate these symptoms.
1. To evaluate the psychometric properties of the MDASI-Spine in patients with tumors involving the spine or spinal cord.
1. To describe the severity of commonly occurring symptoms experienced by persons with spine tumors.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module|
- Overall MDASI Score [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
- Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
MDASI-Spine Tumor Module Survey
M. D. Anderson Symptom Inventory-Spine (survey) of patients with a tumor on the spine or spinal cord.
Survey about the severity of certain symptoms lasting 10-15 minutes.
Other Name: MDASI-Spine
If you agree to take part in this study, you will complete the M. D. Anderson Symptom Inventory-Spine Tumor Module survey. This survey will ask you to rate the severity of certain symptoms you may have had in the last 24 hours on a scale of 0 (not present) to 10 (the most severe you can imagine). You will also be asked to rate how your symptoms get in the way of your daily activities using the same 0 to 10 scale. This survey should take about 10-15 minutes to complete.
Information regarding your clinical history (tumor type, location, treatment, and other medications) and demographic information (age, gender, ethnicity, religion, educational level, and marital status) will also be collected. This information will be used to evaluation whether there is an association between symptom severity and these factors.
Once you have completed the survey, your participation on this study will be over.
This is an investigational study. Up to 128 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430872
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Terri S. Armstrong, PhD||M.D. Anderson Cancer Center|