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Trial record 10 of 22 for:    aospine

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 : Completed
First Posted : April 5, 2013
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Orthopaedic Research Foundation
Information provided by (Responsible Party):
AOSpine International

Tracking Information
First Submitted Date March 28, 2013
First Posted Date April 5, 2013
Last Update Posted Date February 13, 2020
Study Start Date August 2013
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 2, 2013)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)
Official Title The Epidemiology, Process and Outcomes of Spine Oncology
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with metastatic spine disease
Condition Secondary Malignant Neoplasm of Vertebral Column
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 12, 2020)
454
Original Estimated Enrollment
 (submitted: April 2, 2013)
200
Actual Study Completion Date December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Hungary,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01825161
Other Study ID Numbers SPN-12-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AOSpine International
Study Sponsor AOSpine International
Collaborators Orthopaedic Research Foundation
Investigators
Principal Investigator: Charles G Fisher, MD Vancouver General Hospital and the University of British Columbia
PRS Account AOSpine International
Verification Date July 2019