Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients with Brain Metastases

Not Applicable

Active, not recruiting

• Conditions: Metastatic Malignant Solid Neoplasm; Metastatic Malignant Neoplasm in the Brain
• Interventions: Behavioral: Neuropsychological Assessment; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT05503251
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-16
• Study Start: 2022-08-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-04-28
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (neuropsychological evaluation)	Questionnaire Administration	Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
Arm II (usual care)	Questionnaire Administration	Patients receive usual care.
Arm I (neuropsychological evaluation)	Quality-of-Life Assessment	Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
Arm II (usual care)	Quality-of-Life Assessment	Patients receive usual care.
Arm I (neuropsychological evaluation)	Neuropsychological Assessment	Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.
Arm II (usual care)	Best Practice	Patients receive usual care.

Primary Outcome Measures

Name	Time	Method
Quality of life (QOL)	Up to 12 months after radiation therapy	Will be measured by the Functional Assessment of Cancer Therapy Scale-Brain instrument. Linear models will be employed to measure QOL score (converted to a 0- to 100-point scale).

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States