Development of the MDASI-Spine Tumor Module

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT00430872

First received: February 1, 2007

Last updated: July 31, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2007

Last Updated Date

July 31, 2012

Start Date ^ICMJE

January 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall MDASI Score [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00430872 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Development of the MDASI-Spine Tumor Module

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with a tumor on the spine or spinal cord.

Condition ^ICMJE

Spinal Cord Tumor

Intervention ^ICMJE

Behavioral: Survey

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

Other Name: MDASI-Spine

Study Group/Cohort (s)

MDASI-Spine Tumor Module Survey

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

Intervention: Behavioral: Survey

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

128

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00430872

Other Study ID Numbers ^ICMJE

2006-0809

Has Data Monitoring Committee

Responsible Party

M.D. Anderson Cancer Center

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Terri S. Armstrong, PhD

M.D. Anderson Cancer Center

Information Provided By

M.D. Anderson Cancer Center

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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