The Epidemiology, Process and Outcomes of Spine Oncology
18 Years
75 Years
Both
Secondary Malignant Neoplasm of Vertebral Column
Trial Information
The Epidemiology, Process and Outcomes of Spine Oncology
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
- Participation in a clinical trial of another investigational drug or device within
the past 30 days
- A disease or condition that would, in opinion of the investigator, preclude accurate
evaluation (e.g. significant psychiatric disease)
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Change in Spine Cancer Outcomes Questionnaire (SCOQ)
Outcome Description:
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.
Outcome Time Frame:
0, 6, 12, 26, 52 and 104 weeks
Safety Issue:
No
Principal Investigator
Charles G Fisher, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vancouver General Hospital and the University of British Columbia
Authority:
United States: Institutional Review Board
Study ID:
SPN-12-002
NCT ID:
NCT01825161
Start Date:
May 2015
Completion Date:
May 2018
Related Keywords:
- Secondary Malignant Neoplasm of Vertebral Column
- Neoplasms
- Neoplasms, Second Primary
- Bone Neoplasms
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| Kansas University Medical Center | Kansas City,, Kansas 66160-7390 |
| John Hopkins University | Baltimore, Maryland 21231 |
| The CORE Institute | Sun City West, Arizona 85375 |
| Thomas Jefferson University and Rothman Institute Orthopaedics | Philadelphia, Pennsylvania 19107 |
