Feasibility/Acceptability of Attentional-Control Training in Survivors

Summary

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.

Conditions

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

Interventions

DEVICE

EndeavorRx

EndeavorRx 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.

OTHER

Control video game

The 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• George Washington University

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Children's National Research Institute

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-14

Primary Completion

2025-08-31

Completion

2025-08-31

FDA Device

Yes

Countries

• United States

Study Locations