Brain Metastases, AdultNCT06280300
Multi-disciplinary Care for Brain Metastases
A study testing health services intervention in people with Brain Metastases, Adult, run by University of Vermont Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult
- What is being tested?
- health services intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are < 18 years of age are not eligible.
- Patients who are Pregnant are not eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Intensive Multi-Disciplinary Care Initiative for Patients With Newly Diagnosed Brain Metastases
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.
Read the 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.
- Conditions
- Brain Metastases, Adult
- Being tested
- health services intervention
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health services interventionOther
Health services intervention
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Other: health services intervention |
| Multidisciplinary Care | Experimental | Not described Receives: Other: health services intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcomes
Symptom burden based on patient reporting on Brain Mets Symptom Inventory
Measured: 6-12 months
Secondary outcomes (3)
Feasibility
Number of % of patients able to complete protocol-specified activities
Measured: 6-12 months
Patient understanding of prognosis
Concordance with physician predication of prognosis
Measured: 6-12 months
survival
Survival outcomes for patients receiving best supportive care
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start16 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cohort study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alissa Thomas, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280300
- Sponsor's protocol ID
- UVMMC2203
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Multi-Disciplinary Care Initiative for Patients With Newly Diagnosed Brain Metastases
- ClinicalTrials.gov ID
- NCT06280300
- Acronym / sponsor ID
- UVMMC2203
- Conditions
- Brain Metastases, Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cohort study
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: health services intervention |
| Multidisciplinary Care | Experimental | Other: health services intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are < 18 years of age are not eligible.
- Patients who are Pregnant are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health services interventionHealth services intervention | Other | Multidisciplinary Care, Standard of Care |
Primary outcome
Patient reported outcomes
Time frame: 6-12 months
Symptom burden based on patient reporting on Brain Mets Symptom Inventory
3 secondary outcomes
Feasibility
Time frame: 6-12 months
Patient understanding of prognosis
Time frame: 6-12 months
survival
Time frame: 6-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Brain Metastases, Adult
Not yet recruitingObservational study
Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
Brain Tumor Adult, Brain Metastases From Solid Tumors
RecruitingPhase 2
Tarlatamab for SCLC Brain Metastases
Small Cell Lung Cancer, Brain Metastases, Adult
RecruitingPhase 3
Testing a New Treatment Strategy to Improve Secondary Stroke Prevention for Older Adults: The STROKE75+ Trial
Stroke, Ischemic
Not yet recruitingPhase 2
Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)
High Grade Glioma (HGG) of the Brain With BRAF Aberration, High Grade Glioma (III or IV)
RecruitingObservational study
Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
Brain Tumor, Primary, Brain Metastases, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health services intervention in people with Brain Metastases, Adult, run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alissa A Thomas, MD (802-847-8400, athoma21@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported outcomes (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.