Development of the MDASI-Spine Tumor Module

NCT00430872 | Completed

• 1 other identifier: 2006-0809
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Tumor

Keywords

Spinal Cord Tumor; Intramedullary Spinal Cord Tumor; Extramedullary Spinal Cord Tumor; Symptoms; Survey

Outcome Measures

Primary Outcomes (1)

• Overall MDASI Score

  18 Months

Secondary Outcomes (1)

• Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale

  18 Months

Study Arms (1)

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

Interventions

Survey BEHAVIORAL

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

Also known as: MDASI-Spine

MDASI-Spine Tumor Module Survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a tumor on the spine or spinal cord.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Terri S. Armstrong, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2007
• First Posted: February 2, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)