Development of the MDASI-Spine Tumor Module - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00430872

Purpose

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.

Condition	Intervention
Spinal Cord Tumor	Behavioral: Survey

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

The goal of this research study is to learn the severity of certain symptoms in patients with tumors of the spine or spinal cord. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Researchers also want to learn if the M. D. Anderson Symptom Inventory-Spine is a good way to rate these symptoms. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	128
Study Start Date:	January 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with a tumor on the spine or spinal cord.	Behavioral: Survey Survey about the severity of certain symptoms lasting 10-15 minutes.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with a tumor on the spine or spinal cord.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430872

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Terri S. Armstrong, PhD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Terri S. Armstrong, PhD/Associate Professor )
Study ID Numbers:	2006-0809
Study First Received:	February 1, 2007
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00430872 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

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

Study placed in the following topic categories:

Spinal Cord Diseases
Spinal Cord Neoplasm
Central Nervous System Diseases

Spinal Cord Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Nervous System Diseases

Central Nervous System Diseases
Spinal Cord Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009