--- title: Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases nct_id: NCT05503251 overall_status: ACTIVE_NOT_RECRUITING phase: PHASE2 sponsor: Ohio State University Comprehensive Cancer Center study_type: INTERVENTIONAL primary_condition: Metastatic Malignant Neoplasm in the Brain countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05503251.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05503251" ct_last_update_post_date: 2025-12-24 last_seen_at: "2026-05-12T07:09:06.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Neuropsychological Care for Maintaining Quality of Life After Radiation Therapy in Patients With Brain Metastases **Official Title:** Effect of Early Integrated Neuropsychological Care in Patients With Brain Metastases - A Phase 2 Randomized Controlled Trial **NCT ID:** [NCT05503251](https://clinicaltrials.gov/study/NCT05503251) ## Key Facts - **Status:** ACTIVE_NOT_RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 110 - **Lead Sponsor:** Ohio State University Comprehensive Cancer Center - **Conditions:** Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm - **Start Date:** 2022-08-30 - **Completion Date:** 2026-06-28 - **CT.gov Last Update:** 2025-12-24 ## 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. ## Eligibility - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Arm I (neuropsychological evaluation)** (EXPERIMENTAL) — Patients undergo neuropsychological evaluations with a certified neuropsychologist at baseline, 3 months, and 6 months. - **Arm II (usual care)** (ACTIVE_COMPARATOR) — Patients receive usual care. ## Interventions - **Best Practice** (OTHER) — Receive usual care - **Neuropsychological Assessment** (BEHAVIORAL) — Undergo neuropsychological evaluation - **Quality-of-Life Assessment** (OTHER) — Ancillary studies - **Questionnaire Administration** (OTHER) — Ancillary studies ## Primary Outcomes - **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). ## Locations (1) - Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.ohio state university comprehensive cancer center|columbus|ohio|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05503251.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05503251* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*