Validation of Novel Predictive Score for Patients With Spinal Metastases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Metastases
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 219
- Locations
- 1
- Primary Endpoint
- EuroQuol 5-Dimension (EQ5D) profile
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.
Detailed Description
Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.
Investigators
Andrew Schoenfeld
Associate Professor
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •≥ 18 years of age
- •Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum
- •Able to consent for themselves at the time of the intake evaluation
- •Speaks English
Exclusion Criteria
- •Primary bone tumors or leukemia
- •Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum
- •History of prior spine surgery for metastatic disease
Outcomes
Primary Outcomes
EuroQuol 5-Dimension (EQ5D) profile
Time Frame: Up to 3 years
Assessment of state of health and physical/mental function
Survival
Time Frame: Up to 3 years
Mortality is documented using date of death in medical record
Short-Form (SF)-12
Time Frame: Up to 3 years
Assessment of state of health and physical/mental function
Visual Analog Scale (VAS) for pain
Time Frame: Up to 3 years
Assessment of current level of pain
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time Frame: Up to 3 years
Assessment of global health
Secondary Outcomes
- Post-treatment morbidity and readmissions(Up to 3 years)