Computer-Assisted Cognitive Training for Brain Tumor

Recruiting at 30 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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Computer-Assisted Cognitive Training for brain tumor patients?

Research shows that computer-assisted cognitive training can be effective in improving cognitive function in patients with brain tumors and other neurological conditions. A study on the ReMind app, a cognitive rehabilitation program for brain tumor patients, found that most participants rated the program as 'good' or 'excellent' and would recommend it to others, suggesting its potential effectiveness. ^{1 2 3 4 5}

Is computer-assisted cognitive training safe for humans?

Computer-assisted cognitive training has been used safely in various studies with cancer patients, including those with brain tumors and breast cancer. Participants generally reported high satisfaction and adherence, with no significant safety concerns mentioned in the studies. ^{1 3 6 7 8}

How does Computer-Assisted Cognitive Training differ from other treatments for brain tumors?

Computer-Assisted Cognitive Training is unique because it uses technology to help improve cognitive functions in brain tumor patients, offering a flexible and individualized approach that can be accessed remotely. This treatment focuses on enhancing cognitive skills like attention and memory through interactive exercises, making it more accessible and engaging compared to traditional therapies. ^{1 4 5 9 10}

Research Team

Kristina K Hardy

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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

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

I have someone willing to help me during my treatment.

I have a phone and can be contacted.

Exclusion Criteria

Patients with an estimated survival of less than one year

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

I have a brain tumor located in the pons.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Feasibility of the evidence-based cognitive telerehabilitation program Remind for patients with primary brain tumors. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Preliminary exploration of a computerized cognitive battery and comparison with traditional testing in patients with high-grade glioma. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. [2021]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of virtual reality on cognitive dysfunction in patients with brain tumor. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. [2006]

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

Cognitive rehabilitation program to improve cognition of cancer patients treated with chemotherapy: A 3-arm randomized trial. [2021]

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

Disseminability of computerized cognitive training: Performance across coaches. [2020]

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

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Microcomputer and rehabilitation of cognitive cerebral performance disorders]. [2015]

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

Cognitive rehabilitation for early post-surgery inpatients affected by primary brain tumor: a randomized, controlled trial. [2021]