Neuropsychological Care for Brain Metastasis

Overseen By The Ohio State University Comprehensive Cancer Center

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Multiple sclerosis, Alzheimer's, dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how neuropsychological evaluations and interventions (also known as neuropsychological care or cognitive rehabilitation) can improve the quality of life for individuals with cancer that has spread to the brain and are undergoing radiation therapy. The researchers aim to determine if these evaluations can maintain or enhance mental functions and overall life enjoyment after treatment. Participants will either engage in neuropsychological evaluations or receive the usual care for comparison. The trial seeks individuals with a solid tumor diagnosis who are about to start radiation for brain metastases and primarily speak English. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that neuropsychological evaluation and intervention is safe for patients with brain metastasis?

Research shows that neuropsychological tests and treatments are safe for patients with cancer that has spread to the brain. Studies have found that these treatments can improve thinking and decision-making skills in cancer patients, indicating they are generally well-tolerated.

Patients with brain injuries have also benefited from similar treatments, showing improvements in their thinking abilities. These studies reported no major side effects, supporting the treatment's safety.

In the current trial phase, researchers are primarily testing the treatment's effectiveness, but it has already passed initial safety checks. While no treatment is completely without risk, evidence suggests that these tests and treatments are safe for people with brain metastases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how neuropsychological care can specifically benefit patients with brain metastasis. Unlike standard treatments that primarily focus on the physical symptoms of brain metastasis, this approach targets cognitive and emotional health through regular evaluations and interventions with a certified neuropsychologist. By integrating neuropsychological evaluations at baseline, 3 months, and 6 months, researchers aim to uncover how tailored cognitive support can improve overall patient well-being and potentially enhance quality of life.

What evidence suggests that neuropsychological evaluation and intervention might be effective for maintaining quality of life in patients with brain metastases?

Research has shown that special mental health care, such as neuropsychological evaluation and intervention, can help cancer patients with brain tumors think more clearly and feel better. One study found that patients who received this care improved in areas like memory and thinking and felt better overall after their treatment. Another study found similar benefits for people with brain injuries, suggesting this care can also help those with brain tumors. In this trial, participants in one arm will undergo neuropsychological evaluations, while those in another arm will receive usual care. These findings support the idea that mental health care can effectively manage the mental side effects of radiation therapy for brain cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Joshua D. Palmer, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with stage IV solid tumors and brain metastases, who haven't had whole-brain radiation before. They should have a life expectancy of over 6 months. It's not for those with multiple sclerosis, Alzheimer's, dementia, or mental disabilities.

Inclusion Criteria

My cancer is at stage IV and is a solid tumor.

My doctor expects me to live more than 6 months.

I will receive radiation therapy for cancer that has spread to my brain.

Exclusion Criteria

Patient has multiple sclerosis, Alzheimer's, dementia, or mental disability

I have had whole brain radiation therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive standard of care radiation therapy for brain metastases

Varies

Neuropsychological Evaluation

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

6 months

3 visits (in-person)

Follow-up

Participants are monitored for quality of life and cognitive function after radiation therapy

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Neuropsychological Evaluation and Intervention

Trial Overview

The study tests if neuropsychological care by certified experts can help maintain quality of life after radiation therapy in patients with cancer that has spread to the brain. It involves assessments and questionnaires about cognitive function and well-being.

How Is the Trial Designed?

Group I: Arm I (neuropsychological evaluation) Experimental Treatment 3 Interventions

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

Group II: Arm II (usual care) Active Control 3 Interventions

Patients receive usual care.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

Brain metastases occur in about 20% of cancer patients and can lead to neurocognitive decline, which is complicated by prior systemic therapies that may already impair cognitive function.

Focal treatments like radiosurgery and surgical resection are associated with less neurocognitive decline compared to diffuse treatments like whole-brain radiotherapy, highlighting the importance of a multidisciplinary approach in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive aspects of brain metastasis. Wefel, JS., Parsons, MW., Gondi, V., et al.[2018]

Whole brain radiation therapy is the standard treatment for brain metastases, improving neurological symptoms and potentially preventing cognitive decline, but it carries a risk of long-term CNS toxicity that can impair neurocognitive function.

Neuropsychological testing and biomarkers are being explored as tools to measure CNS toxicity, which could help optimize existing therapies and guide the development of new treatments for patients with brain metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological testing and biomarkers in the management of brain metastases. Baschnagel, A., Wolters, PL., Camphausen, K.[2021]

Assessing neurocognitive function and quality of life (QOL) in patients with brain metastases is crucial, as these factors provide insights beyond traditional measures like survival time and disease progression.

Reliable and valid assessments of neurocognitive function and QOL are essential for understanding patients' baseline conditions, monitoring treatment effects, and guiding future treatment decisions, ultimately helping to improve patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive and quality of life measures in patients with metastatic brain disease. Witgert, ME., Meyers, CA.[2022]

Neurocognitive function deficits are prevalent in up to 90% of patients with brain metastases, often resulting from both tumor-related factors and treatments like surgery and radiation.

Recent research highlights effective preventative and rehabilitative strategies, including laser therapy, stereotactic radiosurgery, and the neuroprotectant memantine, which can help mitigate cognitive decline in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preservation of neurocognitive function in the treatment of brain metastases. Parsons, MW., Peters, KB., Floyd, SR., et al.[2022]

In a study of 107 pediatric cancer survivors, it was found that male survivors were less likely to schedule neuropsychological evaluations compared to female survivors, highlighting a potential gender disparity in access to these important services.

Among those evaluated, 24% exhibited severe cognitive impairment and 75% were diagnosed with psychological disorders, indicating a significant need for ongoing support and services for these survivors, despite many not receiving the recommended follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological assessment in pediatric oncology survivorship care: utilization of services, results of evaluation, and educational and behavioral health outcomes. Oswald, K., Bitensky, D., Stuchell, E., et al.[2021]

A study of 32 patients with brain metastasis revealed significant cognitive impairments, particularly in verbal memory, attention, executive functioning, and language, compared to 32 healthy controls.

Despite many patients being able to perform basic self-care activities, cognitive deficits were common, highlighting the need for awareness among patients, caregivers, and healthcare providers regarding the cognitive challenges faced by individuals with brain metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognition in patients with newly diagnosed brain metastasis: profiles and implications. Gerstenecker, A., Nabors, LB., Meneses, K., et al.[2022]

In a study of 96 female breast cancer patients undergoing rehabilitation, neuropsychological interventions did not show specific benefits over a control group, as most test results improved similarly across all groups.

Despite improvements during rehabilitation, some patients continued to experience clinically relevant neuropsychological deficits six months later, indicating a need for ongoing support after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of specific neuropsychological training programs for breast cancer patients after adjuvant chemotherapy. Poppelreuter, M., Weis, J., Bartsch, HH.[2019]

Management of brain metastases focuses on improving both survival and quality of life, with advancements in treatment leading to better outcomes for certain tumor types.

Regular evaluation and adaptation of both anticancer therapies and supportive care are essential to address the neurological symptoms and maintain the patient's functional independence and cognitive abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Supportive care, cognition and quality of life in brain metastases]. Le Rhun, É., Taillibert, S., Blonski, M., et al.[2015]

Cancer survivors often experience cognitive impairment, known as cancer-related cognitive impairment (CRCI), which can affect attention, processing speed, executive functioning, and memory for many years after treatment.

Neuropsychological assessments can effectively identify cognitive strengths and weaknesses in cancer survivors, allowing for targeted interventions that may improve cognitive function and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Changes Related to Cancer Therapy. Vannorsdall, TD.[2017]

Citations

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A phase 2 randomized controlled trial (ATHENA trial).

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Record History | ver. 120: 2021-05-22 | NCT01445483

This is a longitudinal study that will administer serial neuropsychological assessments to patients with brain metastases who receive radiation therapy.

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This phase II trial studies the effect of neuropsychological evaluation and intervention in maintaining quality of life after radiation ...

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Record History | ver. 108: 2021-01-29 | NCT01445483

This is a longitudinal study that will administer serial neuropsychological assessments to patients with brain metastases who receive radiation therapy.

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One study found the compliance rate was 56% at 6 months for cancer patients completing self-reported QOL examinations [106]. Clinicians have ...

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Abstract. Neurocognitive function (NCF) deficits are common in patients with brain metastases, occurring in up to 90% of cases.