The Epidemiology, Process and Outcomes of Spine Oncology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 454
- 试验地点
- 10
- 主要终点
- Change in Spine Cancer Outcomes Questionnaire (SCOQ)
研究概览
简要总结
The main purpose of this study is to utilize a comprehensive, prospective clinical database to collect patient, diagnostic and treatment variables along with disease specific and generic health related quality of life (HRQOL) data on consecutively treated patients with metastatic spine tumors. The objectives are to determine the validity and reliability of the Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes, to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool for predicting the stability of spine in metastatic spine disease, and to determine the efficacy of surgery versus radiotherapy for the treatment of impending instability secondary to metastatic disease of the spine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age between 18 and 75 years
- •Able to read and write English at an elementary level
- •Diagnosis of metastatic tumor of the spine
排除标准
- •The primary cancer site is central nervous system or spine
- •History of substance abuse (recreational drugs, alcohol) within 12 months prior to screening
- •Is a prisoner
- •A disease or condition that would, in opinion of the investigator, preclude accurate evaluation (e.g. significant psychiatric disease)
结局指标
主要结局
Change in Spine Cancer Outcomes Questionnaire (SCOQ)
时间窗: 0, 6, 12, 26, 52 and 104 weeks
This is a new questionnaire, also referred to as the Spine Oncology Self-Assessment, developed by members of the SOSG. It is made up of 5 domains: physical function, neural function, pain, mental health and social function. It was developed as a comparison to the SF-36 for patients with spine tumors. The reliability and validity of this questionnaire will be compared with the SF-36v2.
次要结局
- Change in Pain Numeric Rating Scale (NRS)(0, 6, 12, 26, 52 and 104 weeks)
- Change in Short Form 36 version 2 (SF-36 v2)(0, 6, 12, 26, 52 and 104 weeks)
- Change in EuroQoL 5D (EQ-5D)(0, 6, 12, 26, 52 and 104 weeks)
- Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)(0, 6, 12, 26, 52 and 104 weeks)