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Feasibility of EndeavorRx for Attention Difficulties in Pediatric Cancer Survivors

This study is looking at whether a digital game called EndeavorRx can help improve attention in children who have survived pediatric cancer. Specifically, it's for children aged 8-16 who had acute lymphoblastic leukemia (ALL) or a brain tumor and finished their treatment at least a year ago. EndeavorRx is an action video game designed to improve attention. Participants will either play EndeavorRx or a control video game. The main goals are to see if the game is easy to use, if families are interested in it, and if children stick with the training. This study will enroll about 50 participants and is currently recruiting.

Study design
This is a pilot randomized controlled trial, meaning participants will be randomly assigned to one of two groups. About 50 participants are planned for this study.
What's involved
Participants will complete 4 weeks of training with either EndeavorRx or a control video game. Technical ease-of-use and satisfaction will be reported at the end of this training period.
Compensation
Not stated in the trial record.
Follow-up
Feasibility and satisfaction are measured after 4 weeks of training.

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NCT05528939

Feasibility/Acceptability of Attentional-Control Training in Survivors

Recruiting
NAAges 8–16InterventionalTreatment
Children's National Research Institute
~50 participants
Updated 2025-01-10 on ClinicalTrials.gov
What's tested:EndeavorRxControl video game

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility assessed by patient/family interest
Measured over Baseline
+2 more outcomes measured

Conditions

Pediatric Cancer
Pediatric ALL
Pediatric Brain Tumor
Attention Difficulties
Cognitive Deficit in Attention

Explore related trials

Acute Lymphoblastic LeukemiaBrain NeoplasmChildhood Malignant Neoplasm

Where it's being run

1 sites across 1 states
District of Columbia1

Study leadership

  • Steven Hardy, Ph.D. · PRINCIPAL_INVESTIGATOR · Children's National Research Institute

Who to contact

Steven Hardy, Ph.D.
[email protected]
202-476-5000
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Feasibility assessed by patient/family interestBaseline

    Feasibility will be determined by examining the proportion of eligible patients/families approached about the study who enroll

  • Feasibility assessed by EndeavorRx training adherence ratesAfter completion of 4 weeks of EndeavorRx training

    Participants will be asked to complete 6 EndeavorRx training missions per day, 5 days per week, for 4 weeks, resulting in a possible training of 120 missions. Feasibility will be evaluated by examining the proportion of the sample that completes at least 60 EndeavorRx missions (50%).

  • Feasibility assessed by reports of technical ease-of-use and satisfactionEnd of training (+4 weeks)

    Children and caregivers will be asked, "How easy or difficult was it to access (e.g., turn on device, start the program, use the program)" using a 5-point Likert scale (5 = "Very Easy"). Families will also be asked, "How satisfied or unsatisfied are you with your experience using EndeavorRx?" using a 5-point Likert scale (5 = "Very Satisfied").