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Clinical Trials/NCT06280300
NCT06280300
Recruiting
N/A

Intensive Multi-Disciplinary Care Initiative for Patients With Newly Diagnosed Brain Metastases

University of Vermont Medical Center1 site in 1 country40 target enrollmentNovember 16, 2023

Overview

Phase
N/A
Intervention
health services intervention
Conditions
Brain Metastases, Adult
Sponsor
University of Vermont Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Patient reported outcomes
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases.

Detailed Description

This is a cohort study of patient with newly diagnosed brain metastases assigned to standard of care (SOC) or intensive multi-disciplinary care (IMDC). Care for all patients with brain metastases involves complex medical decision making and requires input for multiple stakeholders, including medical oncology, neurosurgery, radiation oncology, and neuro-oncology. Palliative care should be an essential component of the care team for all patients with brain metastases by the very nature of this advanced malignancy. At the University of Vermont, our current process for diagnosis and management of patients with brain metastases relies heavily on the physician and team who make the initial diagnosis to consult others as they see appropriate. This process may look different for different patients. We rationalize that a systematic approach with intensive multidisciplinary care (IMDC) will benefit patients with brain metastases by providing consistent access to multi-disciplinary discussion.

Registry
clinicaltrials.gov
Start Date
November 16, 2023
End Date
July 1, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alissa Thomas

Associate Professor of Neurological Sciences

University of Vermont Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients of all genders must be at least 18 years of age.
  • Patients must have histologically confirmed, newly diagnosed brain metastases from known or suspected solid tumor primary neoplasms.
  • Patients must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).
  • Patients must be able to complete questionnaires in English.
  • Patients must have the ability to provide informed consent.

Exclusion Criteria

  • Patients who are \< 18 years of age are not eligible.
  • Patients who are Pregnant are not eligible.

Arms & Interventions

Standard of Care

Intervention: health services intervention

Multidisciplinary Care

Intervention: health services intervention

Outcomes

Primary Outcomes

Patient reported outcomes

Time Frame: 6-12 months

Symptom burden based on patient reporting on Brain Mets Symptom Inventory

Secondary Outcomes

  • survival(6-12 months)
  • Patient understanding of prognosis(6-12 months)
  • Feasibility(6-12 months)

Study Sites (1)

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