Development of the MDASI-Spine Tumor Module

Spinal Cord Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430872
• Other study ID #: 2006-0809
• Status: Completed
• Phase: N/A
• First received: February 1, 2007
• Last updated: July 31, 2012
• Start date: January 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Neoplasms
• Spinal Cord Tumor

Intervention

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

Locations

Country	Name	City	State
United States	U.T. M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall MDASI Score		18 Months	No
Secondary	Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale		18 Months	No

External Links

•   UT MD Anderson Cancer Center