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

Completed

• Conditions: Secondary Malignant Neoplasm of Vertebral Column

• Registration Number: NCT01825161
• Lead Sponsor: AO Foundation, AO Spine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Study Start: 2013-08
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Spine Cancer Outcomes Questionnaire (SCOQ)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Pain Numeric Rating Scale (NRS)	0, 6, 12, 26, 52 and 104 weeks	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.
Change in Short Form 36 version 2 (SF-36 v2)	0, 6, 12, 26, 52 and 104 weeks	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).
Change in EuroQoL 5D (EQ-5D)	0, 6, 12, 26, 52 and 104 weeks	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.
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)	0, 6, 12, 26, 52 and 104 weeks	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.

Trial Locations

Locations (10)

National Center for Spinal Disorders; 🇭🇺 Budapest, Hungary

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Sunnybrook Health Sciences Center; 🇨🇦 Toronto, Ontario, Canada

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Toronto Hospital; 🇨🇦 Toronto, Ontario, Canada