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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05503251
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ohio State University Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joshua D Palmer, MD
Principal Investigator Affiliation	Ohio State University Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Arm I (neuropsychological evaluation)

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

Active Comparator: Arm II (usual care)

Patients receive usual care.

Interventions

Other: - Best Practice

Receive usual care

Behavioral: - Neuropsychological Assessment

Undergo neuropsychological evaluation

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Questionnaire Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbus, Ohio

Status

Recruiting

Address

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Site Contact

Joshua D. Palmer, MD

[email protected]

800-293-5066

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