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Development of the MDASI-Spine Tumor Module

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00430872
Enrollment
128
Registered
2007-02-02
Start date
2007-01-31
Completion date
2008-07-31
Last updated
2012-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Tumor

Keywords

Spinal Cord Tumor, Intramedullary Spinal Cord Tumor, Extramedullary Spinal Cord Tumor, Symptoms, Survey

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.

Interventions

BEHAVIORALSurvey

Survey about the severity of certain symptoms lasting 10-15 minutes.

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Design outcomes

Primary

MeasureTime frame
Overall MDASI Score18 Months

Secondary

MeasureTime frame
Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale18 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026