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

NCT05503251 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: OSU-21074NCI-2022-02216
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Quality of life (QOL)

  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).

  Up to 12 months after radiation therapy

Study Arms (2)

Arm I (neuropsychological evaluation)

EXPERIMENTAL

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

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

Arm II (usual care)

ACTIVE COMPARATOR

Patients receive usual care.

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

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm II (usual care)

Neuropsychological Assessment BEHAVIORAL

Undergo neuropsychological evaluation

Also known as: Neuropsychological Examination

Arm I (neuropsychological evaluation)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (neuropsychological evaluation); Arm II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (neuropsychological evaluation); Arm II (usual care)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient received prior whole brain radiation therapy to the brain
• Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis

Interventions

Practice Guidelines as Topic; Standard of Care; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Joshua D Palmer, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 16, 2022
• Study Start: August 30, 2022
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)