Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases
NCT ID: NCT05503251
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2022-08-30
2026-06-28
Brief Summary
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Detailed Description
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I. To evaluate the efficacy of neuropsychological assessment and follow up on preventing decline of quality of life (QOL) as evaluated by the Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) score (validated QOL tool for brain metastases).
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of early neuropsychological assessment and neurocognitive rehabilitation by a neuropsychologist on prevention of neurocognitive decline in patients treated with radiation to brain metastases as evaluated by the Hopkins Verbal Learning Test-Revised (HVLT-R) Delay Recall, Trail Making Test A/B (TMT A/B), and Controlled Oral Word Association Test (COWAT), and Patient Reported Outcomes Measurement Information System (PROMIS)-8 assessment.
II. To identify subsets of patients treated with whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) who receive greater benefits of neuropsychologic evaluation through examining baseline Fact-Br, HVLT-R, TMT A/B, COWAT, and PROMIS-8 completed prior to radiation therapy delivery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
ARM II: Patients receive usual care.
After completion of standard of care radiation therapy, patients are followed up at 3, 6, and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (neuropsychological evaluation)
Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
Neuropsychological Assessment
Undergo neuropsychological evaluation
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (usual care)
Patients receive usual care.
Best Practice
Receive usual care
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive usual care
Neuropsychological Assessment
Undergo neuropsychological evaluation
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient will be treated with radiation therapy for brain metastases
* Primarily English-speaking patient
* Graded Prognostic Assessment (GPA) \>= 2 (estimated survival \> 6 months)
Exclusion Criteria
* Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Joshua Palmer
Principal Investigator
Principal Investigators
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Joshua D Palmer, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2022-02216
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-21074
Identifier Type: -
Identifier Source: org_study_id