This is a multicenter pilot randomized controlled trial, with an active control condition, of the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a cohort of survivors of acute lymphoblastic leukemia or brain tumor ages 8-16 who are \> 1 year from the end of therapy.
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.
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.
Parallel
EndeavorRx
DeviceEndeavorRx is a digital intervention delivered through an action video game that is indicated to improve attention function. EndeavorRx users first complete two discrete tasks: 1) a perceptual discrimination/attention task in which users respond to target stimuli and ignore distractor stimuli (e.g., tapping the screen quickly only when red aliens appear) and 2) a sensorimotor navigation task in which users tilt their device to steer a hovercraft down a river while targeting or avoiding certain objects. Users are subsequently presented with a multitask training session where they complete the perceptual discrimination/attention task and the sensorimotor navigation task simultaneously. Algorithms adapt the program in both real-time and between sessions to automatically adjust the difficulty level.
Control video game
Other interventionThe active control program, used in previous studies of this intervention, was designed to match EndeavorRx on expectancy, engagement, and time on task in the form of a challenging and engaging digital word game, targeting cognitive domains not targeted by EndeavorRx and not primarily associated with attentional difficulties. Users are instructed to find and connect letters on a grid to spell words; points are awarded based on number of words formed, word length, and the use of unusual letters. There is progression in difficulty to maintain engagement and expectation of benefit from patients and their caregivers.
Feasibility assessed by patient/family interest
Feasibility will be determined by examining the proportion of eligible patients/families approached about the study who enroll
Feasibility assessed by EndeavorRx training adherence rates
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 satisfaction
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").
Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of training
The Conners CPT-3 is a standardized computer-administered assessment that uses T scores (M=50, SD=10) where higher scores indicate greater attention problems
Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
The Conners CPT-3 is a standardized computer-administered assessment that uses T scores (M=50, SD=10) where higher scores indicate greater attention problems
Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at end of training
The ADHD-RS-5 is a caregiver-reported questionnaire measure of attentional symptoms based on DSM-5 criteria where higher raw scores indicate greater attention problems
Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
The ADHD-RS-5 is a caregiver-reported questionnaire measure of attentional symptoms based on DSM-5 criteria where higher raw scores indicate greater attention problems
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Children's National Research Institute
Lead sponsor
St. Jude Children's Research Hospital
Collaborator
Children's Hospital of Philadelphia
Collaborator
George Washington University
Collaborator
National Cancer Institute (NCI)
Collaborator
