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

The Ohio State University

Status: Enrolling

Conditions: Metastatic Malignant Solid Neoplasm; Metastatic Malignant Neoplasm in the Brain

Treatments: Behavioral: Neuropsychological Assessment; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05503251

OSU-21074

NCI-2022-02216 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Arm I (neuropsychological evaluation)

Experimental group

Description:

Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months.

Treatment:

Other: Quality-of-Life Assessment

Behavioral: Neuropsychological Assessment

Other: Questionnaire Administration

Arm II (usual care)

Active Comparator group

Description:

Patients receive usual care.

Treatment:

Other: Quality-of-Life Assessment

Other: Best Practice

Other: Questionnaire Administration