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

February 1, 2007
July 31, 2012
January 2007
July 2008   (final data collection date for primary outcome measure)
Overall MDASI Score [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00430872 on ClinicalTrials.gov Archive Site
Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Development of the MDASI-Spine Tumor Module
Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with a tumor on the spine or spinal cord.

Spinal Cord Tumor
Behavioral: Survey
Survey about the severity of certain symptoms lasting 10-15 minutes.
Other Name: MDASI-Spine
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00430872
2006-0809
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Terri S. Armstrong, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

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