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The Epidemiology, Process and Outcomes of Spine Oncology


N/A
18 Years
75 Years
Not Enrolling
Both
Secondary Malignant Neoplasm of Vertebral Column

Thank you

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 CenterHouston, Texas  77030-4096
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Kansas University Medical CenterKansas City,, Kansas  66160-7390
John Hopkins UniversityBaltimore, Maryland  21231
The CORE InstituteSun City West, Arizona  85375
Thomas Jefferson University and Rothman Institute OrthopaedicsPhiladelphia, Pennsylvania  19107