Development of the MDASI-Spine Tumor Module

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Tumor

Intervention / Treatment
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* Behavioral: Survey


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MDASI-Spine Tumor Module Survey<br>M. D. Anderson Symptom Inventory-Spine (survey) of patients with a tumor on the spine or spinal cord. | Behavioral: Survey<br>* Survey about the severity of certain symptoms lasting 10-15 minutes.<br>* Other names: MDASI-Spine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall MDASI Score |  | 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale |  | 18 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Tumor, Intramedullary Spinal Cord Tumor, Extramedullary Spinal Cord Tumor, Symptoms, Survey