What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as radiation therapy, can lead to several side effects including cognitive decline, neurocognitive dysfunction, and mental health issues like depression and anxiety. Radiation therapy, especially when administered to the central nervous system, is known to cause a decline in cognitive function, particularly in children who receive cranial radiation. Cognitive training programs, like the adaptive computerized cognitive training program, aim to mitigate these effects by improving cognitive function, but the effectiveness and potential side effects of these programs are still under study.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, including temozolomide, an oral chemotherapy drug, and bevacizumab, an anti-angiogenic therapy. These treatments are often used in combination with radiation therapy to improve outcomes in patients with glioblastoma. Additionally, cognitive training programs, such as the Adaptive Computerized Cognitive Training Program, are being studied to enhance cognitive function in patients who have undergone radiation therapy. These programs adjust difficulty based on performance and aim to improve the well-being and quality of life of brain tumor survivors.

What other types of research exist?

Promising alternatives to Adaptive Computerized Cognitive Training Program for brain tumor patients include: 1) Pharmacological treatments such as memantine, donepezil, and galantamine, which have shown benefits in cognitive function post-stroke and could be applicable to brain tumor patients. 2) Cognitive Behavioral Therapy (CBT) for addressing cognitive and emotional challenges. 3) Biofeedback and neurofeedback techniques, which have shown potential in managing cognitive symptoms and improving quality of life. 4) Mindfulness-based interventions, which can help with cognitive function and emotional well-being.

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Behavioural Intervention

Computer-Assisted Cognitive Training for Brain Tumor

N/A

Waitlist Available

Led By Kristina K Hardy

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be newly diagnosed or relapsed/progressed with a brain tumor that has not previously been treated with CRT

Be younger than 18 years old

Must not have

Patients with pontine glioma

Patients with a motor, visual, or auditory handicap that prevents computer use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post training completion

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well an adaptive computer-based training program works for younger patients with brain tumors who have had radiation therapy. The program adjusts its difficulty based on the patient's performance to help improve their memory and attention.

Who is the study for?

This trial is for young patients with brain tumors who have finished radiation therapy within the last 4 months. They need to have a caregiver, access to a phone, and understand English. Patients with traumatic brain injury before their tumor diagnosis, pontine glioma, IQ < 70 or severe disabilities that prevent computer use are not eligible.

What is being tested?

The study compares an adaptive computerized cognitive training program against a non-adaptive one to see if they can improve mental function and quality of life after brain radiation therapy in younger patients with brain tumors.

What are the potential side effects?

Since this trial involves cognitive training programs rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience fatigue or frustration during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My brain tumor is either new or has worsened and hasn't been treated with CRT.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a brain tumor located in the pons.

Select...

I cannot use a computer due to a physical disability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post training completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post training completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post training completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with intervention compliance

Other study objectives

Adherence based on total number of training sessions completed

Ease of use based on the item responses to the 13-item Feasibility Interview

Executive function using the Groton Maze Learning task of the CogState battery

+8 more

Side effects data

From 2022 Phase 2 trial • 26 Patients • NCT02017964

56%

Neutrophil count decreased

44%

White blood cell decreased

28%

Lymphocyte count decreased

28%

Platelet count decreased

Other, Progression Of Medulloblastoma

Hearing impaired

Meningitis

Leukocytosis

Hypernatremia

Hypokalemia

Febrile neutropenia

Death NOS

100%

80%

60%

40%

20%

Study treatment Arm

All Eligible Patients (Combination Chemotherapy)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (non-adaptive training program)Experimental Treatment5 Interventions

Patients undergo a home-based, computerized, interactive, non-adaptive training program comprising 3-5 sessions of 15-45 minutes a week for 5-9 weeks. Each patient also has an interventional coach as in arm I. Patients in both arms complete a brief neuropsychological/behavioral assessment comprising the WIS-IV, the CMS, and the CVLT-C at baseline, after completion of study, and at 6 months after completion of study. Additionally, parents complete a parent-report questionnaire to gather information about patient's behaviors, thoughts, emotions, adaptive skills, and social and functional impairment. Parents and children also complete surveys about the program regarding technical feasibility, adherence, ease-of-use, and satisfaction.

Group II: Arm I (interactive training program)Experimental Treatment5 Interventions

Patients undergo a home-based, computerized, interactive training program comprising 3-5 sessions of 15-45 minutes every week for 5-9 weeks. The program contains twelve visually engaging and interesting exercises that target skills involving visual-spatial and verbal WM. The program is adaptive in a way that each difficulty task is automatically adjusted on a trial-by-trail basis to match a patient's current WM. Each patient has an interventional coach who has online access to patient's training sessions and outcomes (pass or fail). Coaches are able to modify the training sequence or make suggestions to patients and/or parents about how progress can be maximized. Coaches also have telephone meetings with patients and/or families once a week to ensure compliance, track progress, provide feedback, and answer questions that arise during training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Assessment

2011

Completed Phase 2

~1420

Psychosocial Assessment and Care

2007

Completed Phase 3

~370

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors, such as radiation therapy, work by damaging the DNA of cancer cells, preventing them from replicating and causing cell death. This is essential for reducing tumor size and controlling the disease. However, radiation can also impact healthy brain tissue, leading to cognitive impairments. Adaptive computerized cognitive training programs aim to counteract these side effects by offering tailored exercises that adjust in difficulty based on the patient's performance, thereby enhancing cognitive function and improving overall quality of life for brain tumor patients.

Advancements in Oncology with Artificial Intelligence-A Review Article.