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
  Purpose

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 Intervention
Spinal Cord Tumor
Behavioral: Survey

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall MDASI Score [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

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

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
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

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:

  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.
  Contacts and Locations
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, see Learn About Clinical Studies.

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 M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00430872     History of Changes
Other Study ID Numbers: 2006-0809
Study First Received: February 1, 2007
Last Updated: July 31, 2012
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

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

ClinicalTrials.gov processed this record on September 22, 2014