Clinical trial NCT00430872: Development of the MDASI-Spine Tumor Module
Official title: Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Tumor
Keywords: Spinal Cord Tumor
Intramedullary Spinal Cord Tumor
Extramedullary Spinal Cord Tumor
Symptoms
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-02-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a tumor on the spine or spinal cord.

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.

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 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.

Primary outcomes:
measure: Overall MDASI Score
timeFrame: 18 Months
Secondary outcomes:
measure: Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale
timeFrame: 18 Months
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T. M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Terri S. Armstrong, PhD
role: PRINCIPAL_INVESTIGATOR
References: