The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO) (EPOSO)
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| ClinicalTrials.gov Identifier: NCT01825161 |
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Recruitment Status :
Completed
First Posted : April 5, 2013
Last Update Posted : February 13, 2020
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Sponsor:
AO Foundation, AO Spine
Collaborator:
Orthopaedic Research Foundation
Information provided by (Responsible Party):
AO Foundation, AO Spine
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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 |
| Actual Enrollment : | 454 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Epidemiology, Process and Outcomes of Spine Oncology |
| Study Start Date : | August 2013 |
| Actual Primary Completion Date : | December 2019 |
| Actual Study Completion Date : | December 2019 |
Primary Outcome Measures :
- 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 :
- 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.
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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
AO Foundation, AO Spine
Orthopaedic Research Foundation
Investigators
| Principal Investigator: | Charles G Fisher, MD | Vancouver General Hospital and the University of British Columbia |
Additional Information:
| Responsible Party: | AO Foundation, AO Spine |
| ClinicalTrials.gov Identifier: | NCT01825161 |
| Other Study ID Numbers: |
SPN-12-002 |
| First Posted: | April 5, 2013 Key Record Dates |
| Last Update Posted: | February 13, 2020 |
| Last Verified: | July 2019 |
Additional relevant MeSH terms:
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Neoplasms |