Development of the MDASI-Spine Tumor Module

Completed

• Conditions: Spinal Cord Tumor
• Interventions: Behavioral: Survey

• Registration Number: NCT00430872
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

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

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Exclusion Criteria

1. Patients < 18 years of age
2. 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDASI-Spine Tumor Module Survey	Survey	M. D. Anderson Symptom Inventory-Spine (survey) of patients with a tumor on the spine or spinal cord.

Primary Outcome Measures

Name	Time	Method
Overall MDASI Score	18 Months

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale	18 Months

Trial Locations

Locations (1)

U.T. M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States