The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO) (EPOSO)

The Epidemiology, Process and Outcomes of Spine Oncology

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.

Study Overview

• Status: Completed
• Conditions: Secondary Malignant Neoplasm of Vertebral Column

• Study Type: Observational
• Enrollment (Actual): 454

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Center
    • Toronto, Ontario, Canada, M5T 2S8
      • University of Toronto Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital
• Hungary
  • Budapest, Hungary, 1126
    • National Center for Spinal Disorders
• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic spine disease

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spine Cancer Outcomes Questionnaire (SCOQ)	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.	0, 6, 12, 26, 52 and 104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Numeric Rating Scale (NRS)	The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.	0, 6, 12, 26, 52 and 104 weeks
Change in EuroQoL 5D (EQ-5D)	The EuroQOL group developed a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it contains 5 questions and provides a simple descriptive profile and a single index value for health status. EQ-5D is designed for self-completion by respondents and is ideally suited for use in mailed surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.	0, 6, 12, 26, 52 and 104 weeks
Change in Short Form 36 version 2 (SF-36 v2)	The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, short-form health survey with 36 questions available in several languages. It yields an eight-scale profile of scores: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. In addition, two composite scores are constructed using factorial modeling, one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS).	0, 6, 12, 26, 52 and 104 weeks
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)	ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit. The modified ISNCSCI used in this study will assess the Motor Score and the ASIA Impairment Scale V 1.3 only.	0, 6, 12, 26, 52 and 104 weeks

Collaborators and Investigators

• Sponsor: AO Foundation, AO Spine
• Collaborators: Orthopaedic Research Foundation
• Investigators: Principal Investigator: Charles G Fisher, MD, Vancouver General Hospital and the University of British Columbia

Publications and helpful links

Helpful Links

• AOSpine
• Orthopedic Research Foundation

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SPN-12-002