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NCT05503251 Clinical Trial

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

Metastatic Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05503251
Other study ID # OSU-21074
Secondary ID NCI-2022-02216
Status Recruiting
Phase N/A
First received
Last updated
Start date August 30, 2022
Est. completion date December 31, 2025

Study information
Verified date November 2022
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State University Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 47
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Best Practice
Receive usual care
Behavioral:
• Neuropsychological Assessment
Undergo neuropsychological evaluation
Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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