Validation of Novel Predictive Score for Patients With Spinal Metastases

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.

Study Overview

• Status: Completed
• Conditions: Spinal Metastases

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.

• Study Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal metastases

Description

Inclusion Criteria:

1. ≥ 18 years of age
2. Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum
3. Able to consent for themselves at the time of the intake evaluation

4. Speaks English

   Exclusion Criteria:

5. Primary bone tumors or leukemia
6. Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum
7. History of prior spine surgery for metastatic disease

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Surgical; Patients treated surgically for spinal metastases
Non-operative; Patients treated non-operatively for spinal metastases
Expectant; Patients receiving no treatment for spinal metastases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Mortality is documented using date of death in medical record	Up to 3 years
EuroQuol 5-Dimension (EQ5D) profile	Assessment of state of health and physical/mental function	Up to 3 years
Short-Form (SF)-12	Assessment of state of health and physical/mental function	Up to 3 years
Visual Analog Scale (VAS) for pain	Assessment of current level of pain	Up to 3 years
Patient-Reported Outcomes Measurement Information System (PROMIS)	Assessment of global health	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-treatment morbidity and readmissions	Post treatment complications and readmissions documented in medical record	Up to 3 years

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Andrew Schoenfeld, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 13, 2020
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2017P000203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No