Multi-disciplinary Care for Brain Metastases

Brain Metastases, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280300
• Other study ID #: UVMMC2203
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: February 2024
• Source: University of Vermont Medical Center
• Contact: Alissa A Thomas, MD
• Phone: 802-847-8400
• Email: athoma21[@]med.uvm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases, Adult
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Other:
• health services intervention
Health services intervention

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory survival outcome	90 day and 1 year survival	6-12 months
Primary	Patient reported outcomes	Symptom burden based on patient reporting	6-12 months
Secondary	Feasibility	Number of patients presented at tumor board and attendance at appointments	6-12 months
Secondary	Patient understanding of prognosis	Concordance with physician predication of prognosis	6-12 months
Secondary	survival	Survival outcomes for patients receiving best supportive care	6-12 months