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Trial Title:
Multi-disciplinary Care for Brain Metastases
NCT ID:
NCT06280300
Condition:
Brain Metastases, Adult
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
cohort study
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
health services intervention
Description:
Health services intervention
Arm group label:
Multidisciplinary Care
Arm group label:
Standard of Care
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Vermont Medical Center
Address:
City:
Burlington
Zip:
05401
Country:
United States
Status:
Recruiting
Start date:
November 16, 2023
Completion date:
November 1, 2025
Lead sponsor:
Agency:
University of Vermont Medical Center
Agency class:
Other
Source:
University of Vermont Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06280300
