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Completed

NCT Number: NCT00430872

Development of the MDASI-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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

survey

Behavioral

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

Other names: MDASI-Spine

Primary outcomes

  1. Overall MDASI Score

    Time frame: 18 Months

Secondary outcomes

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

    Time frame: 18 Months

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 2, 2007
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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