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Development of the MDASI-Spine Tumor Module

NCT ID: NCT00430872

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-07-31

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.

Conditions

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Spinal Cord Tumor

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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MDASI-Spine Tumor Module Survey

M. D. Anderson Symptom Inventory-Spine (survey) of patients with a tumor on the spine or spinal cord.

Survey

Intervention Type BEHAVIORAL

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

Interventions

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Survey

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

Intervention Type BEHAVIORAL

Other Intervention Names

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MDASI-Spine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terri S. Armstrong, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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U.T. M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center

Other Identifiers

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2006-0809

Identifier Type: -

Identifier Source: org_study_id