The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO) (EPOSO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01825161|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2013
Last Update Posted : June 21, 2018
|Condition or disease|
|Secondary Malignant Neoplasm of Vertebral Column|
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||The Epidemiology, Process and Outcomes of Spine Oncology|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Change in Spine Cancer Outcomes Questionnaire (SCOQ) [ Time Frame: 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.
- Change in Pain Numeric Rating Scale (NRS) [ Time Frame: 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 EuroQoL 5D (EQ-5D) [ Time Frame: 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 Short Form 36 version 2 (SF-36 v2) [ Time Frame: 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 International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825161
|United States, Kansas|
|Kansas University Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21218|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Sunnybrook Health Sciences Center|
|Toronto, Ontario, Canada, M4N 3M5|
|University of Toronto Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|National Center for Spinal Disorders|
|Budapest, Hungary, 1126|
|Principal Investigator:||Charles G Fisher, MD||Vancouver General Hospital and the University of British Columbia|