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Clinical Trials/NCT00430872
NCT00430872
Completed
Not Applicable

Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module

M.D. Anderson Cancer Center1 site in 1 country128 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Tumor
Sponsor
M.D. Anderson Cancer Center
Enrollment
128
Locations
1
Primary Endpoint
Overall MDASI Score
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Primary Objective:

  1. To evaluate the psychometric properties of the MDASI-Spine in patients with tumors involving the spine or spinal cord.

Secondary Objective:

  1. To describe the severity of commonly occurring symptoms experienced by persons with spine tumors.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
July 2008
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of a tumor involving the spinal cord (intramedullary or extramedullary)
  • Age \> or = to 18 years of age
  • Ability to speak and read English. Non-English speaking subjects will be included in future studies, once the final instrument has been developed.

Exclusion Criteria

  • Patients \< 18 years of age
  • Evidence of gross cognitive dysfunction limiting memory or ability to complete a self-report questionnaire as determined by evaluation of physician or mid-level provider.

Outcomes

Primary Outcomes

Overall MDASI Score

Time Frame: 18 Months

Secondary Outcomes

  • Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale(18 Months)

Study Sites (1)

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