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

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ClinicalTrials.gov Identifier: NCT01825161
Recruitment Status : Active, not recruiting
First Posted : April 5, 2013
Last Update Posted : June 21, 2018
Sponsor:
Collaborator:
Orthopaedic Research Foundation
Information provided by (Responsible Party):
AOSpine International

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.

Condition or disease
Secondary Malignant Neoplasm of Vertebral Column

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic spine disease
Criteria

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)

Information from the National Library of Medicine

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


Locations
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
Mayo Clinic
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
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
University of Toronto Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Hungary
National Center for Spinal Disorders
Budapest, Hungary, 1126
Sponsors and Collaborators
AOSpine International
Orthopaedic Research Foundation
Investigators
Principal Investigator: Charles G Fisher, MD Vancouver General Hospital and the University of British Columbia

Additional Information:
Responsible Party: AOSpine International
ClinicalTrials.gov Identifier: NCT01825161     History of Changes
Other Study ID Numbers: SPN-12-002
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Second Primary
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases