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Trial Title:
Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases
NCT ID:
NCT05503251
Condition:
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Arm II (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Behavioral
Intervention name:
Neuropsychological Assessment
Description:
Undergo neuropsychological evaluation
Arm group label:
Arm I (neuropsychological evaluation)
Other name:
Neuropsychological Examination
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm I (neuropsychological evaluation)
Arm group label:
Arm II (usual care)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (neuropsychological evaluation)
Arm group label:
Arm II (usual care)
Summary:
This phase II trial studies the effect of neuropsychological evaluation and intervention
in maintaining quality of life after radiation therapy in patients with cancer that has
spread to the brain (metastases). Quality of life refers to the overall enjoyment of
life. It holds varying meanings for different people and may evolve over time. For some
individuals it implies autonomy, empowerment, capability, and choice; for others,
security, social integration, or freedom from stress or illness. Neuropsychological
evaluation is used to examine the cognitive (thinking) consequences of brain damage,
brain disease, and severe mental illness. Deterioration of both quality of life and
cognitive function is common when receiving radiation to the brain. Neuropsychological
evaluation with a certified neuropsychologist may improve quality of life or cognitive
function after radiation therapy.
Detailed description:
PRIMARY OBJECTIVE:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Stage IV histologic diagnosis of solid tumor
- 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 received prior whole brain radiation therapy to the brain
- Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Joshua D. Palmer, MD
Email:
joshua.palmer@osumc.edu
Investigator:
Last name:
Joshua D. Palmer, MD
Email:
Principal Investigator
Start date:
August 30, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05503251
http://cancer.osu.edu