Training program to improve attention in childhood cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.