Feasibility/Acceptability of Attentional-Control Training in Survivors

NCT05528939 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00000150R21CA261877
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Feasibility assessed by patient/family interest

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

  Baseline

• 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%).

  After completion of 4 weeks of EndeavorRx training

• 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").

  End of training (+4 weeks)

Secondary Outcomes (8)

• Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of training

  Baseline and end of training (+4 weeks)

• 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)

  Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)

• Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at end of training

  Baseline and end of training (+4 weeks)

• 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)

  Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)

• Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at end of training

  Baseline and end of training (+4 weeks)

Study Arms (2)

EndeavorRx

EXPERIMENTAL

Children will be asked to begin digital attentional control training at home within 6 weeks of baseline testing and to complete 6 training missions per day (25-30 minutes), 5 days per week, for 4 weeks (total = 120 training missions).

Device: EndeavorRx

Control

ACTIVE COMPARATOR

An active control program designed to replicate aspects of the intervention (e.g., regular use of digital device to access fun educational activities) while engaging cognitive skills not particularly involving attention.

Other: Control video game

Interventions

EndeavorRx DEVICE

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.

EndeavorRx

Control video game OTHER

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.

Control

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's National Research Institute: lead
• St. Jude Children's Research Hospital: collaborator
• Children's Hospital of Philadelphia: collaborator
• George Washington University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Steven Hardy, Ph.D.

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Hardy, Ph.D.

CONTACT

202-476-5000; sjhardy@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-blind, randomized, active-control trial using a 1:1 randomization (stratified by diagnosis) to the intervention or a comparison digital activity.

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: June 14, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)