NCT06280300

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Nov 2023Jul 2027

Study Start

First participant enrolled

November 16, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 29, 2026

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

February 19, 2024

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient reported outcomes

    Symptom burden based on patient reporting on Brain Mets Symptom Inventory

    6-12 months

Secondary Outcomes (3)

  • Feasibility

    6-12 months

  • Patient understanding of prognosis

    6-12 months

  • survival

    6-12 months

Other Outcomes (1)

  • Exploratory survival outcome

    6-12 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR
Other: health services intervention

Multidisciplinary Care

EXPERIMENTAL
Other: health services intervention

Interventions

Health services intervention

Multidisciplinary CareStandard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Alissa A Thomas, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurological Sciences

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 28, 2024

Study Start

November 16, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

January 29, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations