Computer-Assisted Cognitive Training for Brain Tumor

Not currently recruiting at 33 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Oncology Group

Disqualifiers: Pontine glioma, Survival < 1 year, Traumatic brain injury, Motor/visual/auditory handicap, IQ < 70, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5-9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of computer-based brain training programs to improve cognitive function in younger patients treated with radiation for brain tumors. One program adjusts difficulty based on individual progress, while the other remains constant. The goal is to determine which method better enhances mental skills and overall quality of life. Suitable participants include those recently treated for a brain tumor with radiation and who have an available caregiver to assist during the program. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could enhance cognitive recovery strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this computer-assisted cognitive training is safe for younger patients with brain tumors?

Research has shown that computer-assisted brain training has been safely used in studies with cancer patients, including those with brain tumors. In these studies, patients did not report any major side effects from the training. These computer programs have improved thinking, learning, and memory skills without causing harm.

A review of computer-based brain recovery programs for children found that these programs are generally easy for patients to handle, allowing most children to undergo treatment without major problems. The programs in this trial are designed to be fun and flexible, adjusting to each person's needs.

Overall, current evidence supports the safety of these brain training programs for children and young people recovering from brain tumor treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about computer-assisted cognitive training for brain tumors because it offers a personalized approach to improving cognitive function. Unlike traditional methods, which often involve generalized cognitive therapy or medication, this training adapts in real-time to match each patient's cognitive abilities, ensuring a tailored experience. Additionally, the program is home-based and interactive, making it more accessible and engaging for patients, while providing ongoing support through an interventional coach. This innovative method aims to enhance skills like visual-spatial and verbal working memory, which are often impacted in brain tumor patients, potentially leading to better cognitive outcomes and quality of life.

What evidence suggests that computer-assisted cognitive training is effective for brain tumor patients?

Studies have shown that computer programs designed to aid thinking skills can enhance brain function in children who have had brain tumors. In this trial, participants will use one of two types of programs: an interactive training program that adapts to the child's progress or a non-adaptive training program. Research indicates that both types can improve thinking and decision-making skills, though adaptive programs might be more effective. Early results suggest these programs can also enhance quality of life and mental abilities affected by brain radiation treatment. Previous research supports the idea that computer-based exercises can prevent deterioration in thinking skills and aid recovery. ^{1 2 4 6 7}

Who Is on the Research Team?

Kristina K Hardy

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have someone willing to help me during my treatment.

I have a phone and can be contacted.

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

I have a brain tumor located in the pons.

Patients with an estimated survival of less than one year

Patients with a history of traumatic brain injury prior to tumor diagnosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a home-based, computerized, interactive training program for 5-9 weeks, with 3-5 sessions of 15-45 minutes each week. The program is either adaptive or non-adaptive, depending on the arm.

5-9 weeks

Weekly telephone meetings with interventional coach

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, after completion, and at 6 months post-treatment.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Computer-Assisted Cognitive Training

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm II (non-adaptive training program) Experimental Treatment 5 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 Treatment 5 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.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The ReMind app, an iPad-based cognitive rehabilitation program, was found to be feasible for patients with primary brain tumors, with 85% of participants rating it as 'good' or 'excellent' and expressing willingness to recommend it to others.

In a pilot study involving 15 patients, participants completed a significant portion of the training (71% strategy training and 76% retraining), indicating good adherence, although some found the exercises too easy, leading to plans for more challenging content in future evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the evidence-based cognitive telerehabilitation program Remind for patients with primary brain tumors. van der Linden, SD., Sitskoorn, MM., Rutten, GM., et al.[2019]

Computer-assisted cognitive training has been shown to be an effective tool in neurological rehabilitation, particularly for patients with attention deficits, as it allows for precise stimulus representation and reaction time measures.

This type of training is most beneficial when integrated into a comprehensive therapeutic framework, enhancing the overall rehabilitation process and ensuring sufficient therapeutic intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. Reuter, BM., Schönle, PW.[2006]

Cognitive rehabilitation for brain-injured patients is increasingly utilizing computer-assisted therapy, with 73% of surveyed rehabilitation centers incorporating computers to address various cognitive deficits such as attention, memory, and problem-solving.

Effective computer-assisted therapy requires careful supervision by therapists, including detailed patient assessments and individualized software adaptations to optimize treatment outcomes, particularly during rehabilitation and post-rehabilitation phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Microcomputer and rehabilitation of cognitive cerebral performance disorders]. Schönle, PW., Wiebold, G., Wieding, J., et al.[2015]

In a study of 38 brain tumor patients, those who underwent virtual reality (VR) training alongside computer-based cognitive rehabilitation showed significant improvements in various cognitive tests compared to those who only received the computer program.

The VR group demonstrated better results in specific cognitive areas, such as visual and auditory attention, memory span, and processing speed, suggesting that VR training can enhance cognitive recovery in brain tumor patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of virtual reality on cognitive dysfunction in patients with brain tumor. Yang, S., Chun, MH., Son, YR.[2022]

In a study of 167 cancer patients undergoing chemotherapy, a 12-week computer-assisted cognitive rehabilitation program showed a significant improvement in perceived cognitive abilities and working memory compared to other control groups.

Patients in the computer-assisted rehabilitation group also reported better quality of life related to cognition and a reduction in depression symptoms, indicating its potential as a beneficial intervention for managing cancer-related cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation program to improve cognition of cancer patients treated with chemotherapy: A 3-arm randomized trial. Dos Santos, M., Hardy-Léger, I., Rigal, O., et al.[2021]

The study involved 68 survivors of pediatric brain tumors and acute lymphoblastic leukemia, who were either given the Cogmed cognitive intervention or placed on a waitlist, showing that adherence to the program was consistent across different coaches.

While some aspects of participant satisfaction and cognitive outcomes were similar, the influence of different coaching styles on these results suggests that further research is needed to standardize coaching in computerized interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disseminability of computerized cognitive training: Performance across coaches. Fournier-Goodnight, AS., Ashford, JM., Clark, KN., et al.[2020]

An 8-week home-based computerized cognitive training (CCT) program was assessed for feasibility among 19 patients recently treated for hematological malignancies, but adherence was low, with only one participant fully engaging with the program.

Participants found the CCT program easy to follow and expressed a need for improvements, such as personalized feedback and peer support, to enhance adherence, indicating that while CCT may be beneficial, additional support strategies are necessary for effective implementation in the post-treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. Mayo, SJ., Rourke, SB., Atenafu, EG., et al.[2021]

Cognitive training has been shown to significantly improve subjective cognitive function and certain objective cognitive skills, such as working memory and episodic memory, in breast cancer patients experiencing cognitive changes, based on a systematic review of 9 randomized controlled trials involving 666 patients.

Despite these improvements, cognitive training did not lead to significant changes in attention, short-term memory, executive function, or psychological outcomes like anxiety and depression, indicating that while cognitive training can be beneficial, it may not address all cognitive and emotional challenges faced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. Yan, X., Wei, S., Liu, Q.[2023]

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