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NCT Number: NCT05503251

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Neuropsychological Assessment

Behavioral

Undergo neuropsychological evaluation

Other names: Neuropsychological Examination

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Quality of life (QOL)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Effect of Early Integrated Neuropsychological Care in Patients With Brain Metastases - A Phase 2 Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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