Validation of the M.D. Anderson Symptom Inventory-Spine Tumor Module
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Overall MDASI Score
研究概览
简要总结
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:
- To evaluate the psychometric properties of the MDASI-Spine in patients with tumors involving the spine or spinal cord.
Secondary Objective:
- To describe the severity of commonly occurring symptoms experienced by persons with spine tumors.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Overall MDASI Score
时间窗: 18 Months
次要结局
- Proportion of Patients Reporting Symptom Severity >4 on 0-10 Scale(18 Months)