Game-Based Therapy for Attention Skills in Pediatric Cancer Survivors

(FAACTS Trial)

Recruiting at 1 trial location

Overseen By Steven Hardy, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Must be taking: Stimulants

Disqualifiers: Photosensitive seizures, Motor handicap, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a game-based therapy called EndeavorRx can improve attention skills in children who have survived acute lymphoblastic leukemia or a brain tumor. The trial compares this digital treatment to a control program featuring fun educational activities. It targets children aged 8-16 who completed cancer treatment over a year ago and are stable. Participants should have attention issues and either not be on stimulant medication or have maintained a stable dose for at least 30 days. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance attention skills in young cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking stimulant medication for attention difficulties, you must have been on a stable dose for at least 30 days before joining the trial.

What prior data suggests that EndeavorRx is safe for pediatric cancer survivors?

Research has shown that EndeavorRx, a video game therapy, has undergone testing in several studies for safety. In trials involving over 600 children with ADHD, researchers reported no serious side effects. Two significant studies, which included 342 participants, found no major safety concerns. Designed to help improve attention in kids, this digital therapy has received FDA approval for children aged 8-12 years with ADHD. Based on its past use and safety record, EndeavorRx appears well-tolerated by children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for attention issues in pediatric cancer survivors that often involve medication or traditional behavioral therapies, EndeavorRx is a game-based digital therapy. It stands out because it uses an engaging video game format to specifically target and improve attentional control, making therapy fun and interactive. Researchers are excited about EndeavorRx because it offers a non-invasive, side-effect-free alternative that children can use at home, potentially increasing adherence and effectiveness.

What evidence suggests that EndeavorRx might be an effective treatment for attention skills in pediatric cancer survivors?

Research has shown that EndeavorRx, which participants in this trial may receive, can improve attention in children with ADHD. In studies involving over 600 children, this treatment led to noticeable improvements in attention. Specifically, 73% of the children reported better attention after using EndeavorRx. While this trial focuses on children who have survived cancer, the positive results in children with ADHD suggest it might also help with attention issues in these kids. This game-based therapy could offer a promising way to enhance attention skills. Participants in the control arm will engage with a different video game designed to replicate aspects of the intervention without specifically targeting attention skills. ^{3 6 7 8 9}

Who Is on the Research Team?

Steven Hardy, Ph.D.

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for children aged 8-16 who survived acute lymphoblastic leukemia or brain tumor, are more than a year post-treatment, and have attention difficulties. They must speak English and have caregiver support. Kids on stable ADHD meds can join; those with certain disabilities, seizures, low IQ, or prioritized mental health conditions cannot.

Inclusion Criteria

I am between 8 and 16 years old.

I have a caregiver available to help me with cognitive training.

Participating child and caregiver are fluent in spoken English

Exclusion Criteria

Participants identified during the baseline assessment as having a full-scale IQ < 80, as estimated by WASI-II (Vocabulary and Matrix Reasoning), will not be randomized

My mental health condition needs immediate treatment over participating in any cognitive training.

A motor, visual, or auditory handicap that prevents computer use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive EndeavorRx or active control intervention, with 25-30 minute sessions per day, 5 days per week, for 4 weeks

4 weeks

Home-based, daily sessions

Follow-up

Participants are monitored for changes in attention and executive functioning, with assessments at 4 months post-training

16 weeks

Assessments at 4 months post-training

What Are the Treatments Tested in This Trial?

Interventions

• Control video game
• EndeavorRx

Trial Overview The study tests the feasibility and initial effectiveness of a game called EndeavorRx designed to improve attention in pediatric cancer survivors against a control video game. It's a multi-center pilot study where participants are randomly assigned to either the test game or an active control condition.

How Is the Trial Designed?

Group I: EndeavorRx Experimental Treatment 1 Intervention

Children will be asked to begin digital attentional control training at home within 6 weeks of baseline testing and to complete 6 training missions per day (25-30 minutes), 5 days per week, for 4 weeks (total = 120 training missions).

Group II: Control Active Control 1 Intervention

An active control program designed to replicate aspects of the intervention (e.g., regular use of digital device to access fun educational activities) while engaging cognitive skills not particularly involving attention.

EndeavorRx is already approved in United States for the following indications:

Approved in United States as EndeavorRx for:

• Improving attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

St. Jude Children's Research Hospital

Collaborator

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

A study involving 27 children with ADHD showed that an intervention using board games significantly improved executive functions, particularly linguistic short-term memory and conduct problems, compared to a wait-list control group.

The improvements were noted immediately after the intervention, suggesting that board games could be an effective therapeutic tool for managing ADHD symptoms, although further research is needed to confirm long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of the Efficacy of a Cognitive Training Based on Board Games in Children with Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial. Estrada-Plana, V., Esquerda, M., Mangues, R., et al.[2020]

In a study of 70 childhood cancer survivors, 27% met the criteria for ADHD, which was linked to greater impairments in IQ and working memory, highlighting the need for targeted evaluations in this group.

Parental ratings of attention problems can serve as a useful screening tool to identify survivors at risk for neuropsychological difficulties, although the screening showed low sensitivity but higher specificity for detecting these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential utility of parent-reported attention screening in survivors of childhood cancer to identify those in need of comprehensive neuropsychological evaluation. Hardy, KK., Willard, VW., Wigdor, AB., et al.[2020]

A new computerized training program designed to improve executive functioning and self-control in children with ADHD shows promising initial results.

Future research will focus on testing this program with larger groups of children, assessing how well the training effects carry over into everyday life, and increasing engagement by incorporating more game-like features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Braingame Brian": Toward an Executive Function Training Program with Game Elements for Children with ADHD and Cognitive Control Problems. Prins, PJ., Brink, ET., Dovis, S., et al.[2015]

The pilot study involving 40 children with ADHD demonstrated that an executive functioning (EF) training program with game elements led to significant improvements in EF and ADHD behaviors compared to a wait-list group, with effects maintained over a 9-week follow-up.

In children who were also treated with methylphenidate, the EF training provided additional benefits, suggesting that combining medication with cognitive training may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the efficacy of a computerized executive functioning remediation training with game elements for children with ADHD in an outpatient setting: outcome on parent- and teacher-rated executive functioning and ADHD behavior. van der Oord, S., Ponsioen, AJ., Geurts, HM., et al.[2022]

In a study of 33 pediatric medulloblastoma survivors aged 7-18, parent-reported attention problems were significantly linked to social functioning, indicating that attention deficits can impact social skills in these survivors.

Self-reported attention ratings did not correlate with social functioning, suggesting that parents may have a better perspective on their child's attention issues compared to the children's self-assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of attention on social functioning in pediatric medulloblastoma survivors. Holland, AA., Colaluca, B., Bailey, L., et al.[2018]

The study identified that girls with ADHD showed the most significant improvements in planning and organizing skills after participating in a Serious Game (SG) intervention, indicating a targeted benefit for this subgroup.

Among boys, those with lower levels of hyperactivity and higher levels of Conduct Disorder (CD) symptoms also experienced greater improvements in planning and organizing skills, suggesting that specific characteristics can influence the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A serious game for children with Attention Deficit Hyperactivity Disorder: Who benefits the most? Bul, KCM., Doove, LL., Franken, IHA., et al.[2018]

Survivors of pediatric brain tumors with attention problems exhibited significantly higher levels of depression and externalizing behaviors, as well as impaired family relationships compared to those without attention issues, both at baseline and two years later.

Attention problems at baseline were strong predictors of poorer psychosocial outcomes, indicating the need for careful evaluation and support for these patients to improve their long-term psychosocial functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Attention Problems on Psychosocial Functioning in Childhood Brain Tumor Survivors: A 2-Year Postcraniospinal Irradiation Follow-up. Oh, Y., Seo, H., Sung, KW., et al.[2018]

Methylphenidate has shown consistent benefits in improving sustained attention among childhood cancer survivors, particularly in those with attention-deficit/hyperactivity disorder (ADHD).

Survivors of childhood cancer experienced greater improvements in selective attention compared to sustained attention, suggesting that higher doses of methylphenidate may be more effective for children with broader attentional deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating methylphenidate's efficacy on selective and sustained attentional deficits to those reported in childhood cancer survivors: A qualitative review. Hagan, AJ., Verity, SJ.[2023]

The Cognitive Remediation Program (CRP) showed promise in improving attention and academic achievement in a randomized clinical trial involving 161 childhood cancer survivors aged 6 to 17, who had attentional deficits after treatment.

While the improvements were statistically significant, the effect sizes were modest, indicating that further research is needed to enhance the program's effectiveness and to explore its long-term benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter, randomized clinical trial of a cognitive remediation program for childhood survivors of a pediatric malignancy. Butler, RW., Copeland, DR., Fairclough, DL., et al.[2022]

A pilot study involving 9 childhood cancer survivors showed that a 12-week home-based computerized cognitive training program significantly improved working memory and reduced attention problems.

The intervention was found to be feasible and acceptable, suggesting it could be a promising approach for addressing cognitive deficits in childhood cancer survivors, although larger studies are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in survivors of childhood cancer: a pilot study. Hardy, KK., Willard, VW., Bonner, MJ.[2023]

In a study of 364 children with brain tumors, acute lymphoblastic leukemia, or ADHD-I, those with ADHD-I exhibited significantly higher symptoms of sluggish cognitive tempo (SCT) compared to oncology patients, suggesting different underlying mechanisms for attention issues in these groups.

Latent profile analysis revealed distinct SCT symptom profiles between children with ADHD-I and those with cancer diagnoses, indicating that while SCT can be relevant for pediatric oncology survivors, their symptoms may manifest differently than in ADHD-I cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sluggish cognitive tempo profiles in survivors of childhood cancer as compared to children with attention-deficit/hyperactivity disorder. Peterson, RK., Holingue, C., Jacobson, LA.[2023]

Game-based digital therapeutics (DTx), like EndeavorRx®, significantly improved inattention and hyperactivity/impulsivity in children with ADHD compared to control groups, based on assessments from parents and teachers.

However, traditional medication was found to be more effective than game-based DTx in reducing inattention and hyperactivity/impulsivity, indicating that while DTx offers a beneficial alternative, it may not replace conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. Oh, S., Choi, J., Han, DH., et al.[2023]

Citations

1. endeavorrx.com endeavorrx.com/the-research/

ADHD Research | EndeavorRx® Study For ADHD in Children EndeavorRx® improved objective attention in over 600 children with ADHD ages 8-12, across 5 clinical studies. Learn more about the FDA-authorized Treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05528939

Feasibility/Acceptability of Attentional-Control Training in ... We propose to assess the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a pilot randomized, controlled trial. Survivors of ALL or brain ...

3. endeavorrx.com endeavorrx.com/

EndeavorRx® - ADHD Video Game Treatment for Kids | FDA ... 68% of parents reported improvement in ADHD-related impairments after two months of treatment. 2. 73% of children reported an improvement in their attention. 1.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2988638/

Long-Term Efficacy of Methylphenidate in Enhancing ... Methylphenidate (MPH) ameliorates attention problems experienced by some cancer survivors in the short term, but its long-term efficacy is unproven.

5. innovations-report.com innovations-report.com/health-life/health-and-medicine/childhood-cancer-survivors-show-sustained-benefit-161598/

Childhood Cancer Survivors Benefit From Common ADHD ... After a year of methylphenidate, young cancer survivors scored better on tests of sustained attention. Parent, teacher and survivor ratings of ...

6. endeavorrx.com endeavorrx.com/regulations/

Indications, Safety & Caution | EndeavorRx® No serious adverse events were reported. Of 342 participants who received AKL-T01 in the two clinical trials supporting EndeavorRx authorization for age ranges ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200026.pdf

DEN200026 summary - accessdata.fda.gov EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with ...

8. endeavorrx.com endeavorrx.com/wp-content/uploads/2021/08/EndeavorRx_IFU_1_5.pdf

Instructions for use EndeavorRx has been evaluated in over 600 children with ADHD across 5 clinical studies: • A study of 348 children with ADHD (not receiving ADHD medication), ...

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02674633

Software Treatment for Actively Reducing Severity of ADHD The purpose of this study is to evaluate the effects of videogame-like digital therapies on attentional functioning and symptoms in children ...