Training program to improve attention in childhood cancer survivors
FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors
This study is testing if a special video game can help improve attention and thinking skills in kids aged 8-16 who have survived leukemia or brain tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 8 Years to 16 Years |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT05528939 on ClinicalTrials.gov |
What this trial studies
This multicenter pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary efficacy of EndeavorRx, an FDA-approved electronic attentional-control training program, for survivors of acute lymphoblastic leukemia (ALL) or brain tumors aged 8-16 who are more than one year post-therapy. The study aims to address cognitive impairments, particularly in attention and executive functioning, that often affect these survivors due to their cancer treatments. Approximately 50 participants will be screened across three pediatric oncology centers, with 40 participants randomized to either the EndeavorRx intervention or a control video game. The goal is to assess whether this non-pharmacological intervention can help improve cognitive outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-16 who have a history of acute lymphoblastic leukemia or brain tumors and are at least one year post-therapy.
Not a fit: Patients with significant mental health conditions or those unable to use a computer due to physical limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance cognitive functioning and quality of life for childhood cancer survivors facing attention difficulties.
How similar studies have performed: While EndeavorRx has shown efficacy in youth with ADHD, this specific application for childhood cancer survivors is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 8-16 years at time of screening. * History of diagnosis of acute lymphoblastic leukemia (ALL) or brain tumor (BT). * At least 1 year from completion of planned therapy and stable from a disease standpoint. * Participating child and caregiver are fluent in spoken English. * Availability of a caregiver who is willing and capable of providing support and supervision during cognitive training. * Participating child is either not taking any prescribed stimulant medication for attention difficulties or has been prescribed a stable dose of stimulant medication for attention difficulties for at least 30 days prior to enrollment. * Only patients with a T-score ≥ 75th percentile on the CPT-3 Omission Errors scale or on the BRIEF-2 Cognitive Regulation Index will be randomized. Exclusion Criteria: * A history of photosensitive seizures. * A motor, visual, or auditory handicap that prevents computer use. * A mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training. * 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.
Where this trial is running
Washington D.C., District of Columbia
- Children's National Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Steven Hardy, Ph.D. — Children's National Research Institute
- Study coordinator: Steven Hardy, Ph.D.
- Email: sjhardy@childrensnational.org
- Phone: 202-476-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.