Neuropsychological Care for Brain Metastasis

Overseen By The Ohio State University Comprehensive Cancer Center

Age: Any Age

Sex: Any

Trial Phase: Academic

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)

Compensation: Varies

Number of Visits: 6

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Neuropsychological Care for Brain Metastasis is an effective treatment?

The available research shows that neuropsychological care can help improve the quality of life and cognitive function in patients with brain metastases. This treatment is important because it helps assess and monitor cognitive abilities and well-being, which are often affected by brain metastases and their treatments. While other treatments like whole brain radiation therapy and chemotherapy are used to manage brain metastases, they can lead to cognitive impairments. Neuropsychological care helps in understanding and minimizing these effects, making it a valuable part of the overall treatment plan. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Neuropsychological Evaluation and Intervention, Neuropsychological Care, and Cognitive Rehabilitation for brain metastasis?

Neuropsychological evaluation and care are important for understanding and managing cognitive function and quality of life in patients with brain metastases. These assessments help monitor treatment effects and guide interventions to minimize symptoms and improve well-being. ^{1 2 3 4 5}

What safety data exists for neuropsychological care in brain metastasis treatment?

The safety data for neuropsychological care in brain metastasis treatment is not directly addressed in the provided research. However, neuropsychological testing is used to assess cognitive function and manage CNS toxicity in patients with brain metastases. These tests help optimize therapies and develop new treatments, indicating a focus on understanding and mitigating neurocognitive decline associated with treatment. The research highlights the importance of balancing treatment efficacy with neurocognitive outcomes, suggesting that neuropsychological care is considered a supportive measure to improve quality of life and cognitive function in patients undergoing treatment for brain metastases. ^{3 4 5 6 7}

Is neuropsychological care safe for humans?

Neuropsychological care, which includes cognitive rehabilitation and evaluation, has been used in cancer patients to help manage cognitive issues related to treatment. While the research does not specifically address safety, these interventions are generally considered safe as they focus on assessing and improving mental functions without involving invasive procedures or medications. ^{3 4 5 6 7}

Is the treatment in the trial 'Neuropsychological Care for Brain Metastasis' a promising treatment?

Yes, the treatment is promising because it focuses on preserving and improving brain function in patients with brain metastases. It uses strategies like neuropsychological care to help manage and reduce cognitive problems, which are common in these patients. This approach can improve the quality of life for patients by helping them maintain their mental abilities and independence. ^{4 5 7 8 9}

How does neuropsychological care differ from other treatments for brain metastasis?

Neuropsychological care for brain metastasis is unique because it focuses on preserving and improving cognitive function, which is often impaired by both the tumors and their treatments. Unlike traditional treatments like surgery or radiation, this approach integrates neuropsychology to help patients and families manage cognitive patterns and guide rehabilitative therapies, aiming to maintain quality of life and functional independence. ^{4 5 7 8 9}

Research Team

Joshua D. Palmer, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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.

I primarily speak English.

My doctor expects me to live more than 6 months.

Exclusion Criteria

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

I have had whole brain radiation therapy before.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Neuropsychological assessment in pediatric oncology survivorship care: utilization of services, results of evaluation, and educational and behavioral health outcomes. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Neurocognitive and quality of life measures in patients with metastatic brain disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of specific neuropsychological training programs for breast cancer patients after adjuvant chemotherapy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Neuropsychological testing and biomarkers in the management of brain metastases. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[Supportive care, cognition and quality of life in brain metastases]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive Changes Related to Cancer Therapy. [2017]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Neurocognitive aspects of brain metastasis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Preservation of neurocognitive function in the treatment of brain metastases. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cognition in patients with newly diagnosed brain metastasis: profiles and implications. [2022]