Development of the MDASI-Spine Tumor Module

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430872
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Spinal Cord Tumor Behavioral: Survey

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 : Observational
Actual Enrollment : 128 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module
Study Start Date : January 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Group/Cohort Intervention/treatment
MDASI-Spine Tumor Module Survey
M. D. Anderson Symptom Inventory-Spine (survey) of patients with a tumor on the spine or spinal cord.
Behavioral: Survey
Survey about the severity of certain symptoms lasting 10-15 minutes.
Other Name: MDASI-Spine

Primary Outcome Measures :
  1. Overall MDASI Score [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale [ Time Frame: 18 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a tumor on the spine or spinal cord.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430872

United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Terri S. Armstrong, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00430872     History of Changes
Other Study ID Numbers: 2006-0809
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Spinal Cord Tumor
Intramedullary Spinal Cord Tumor
Extramedullary Spinal Cord Tumor

Additional relevant MeSH terms:
Spinal Cord Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases