Feasibility/Acceptability of Attentional-Control Training in Survivors

NCT ID: NCT05528939

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2025-08-31

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.

Detailed Description

Survival rates are increasing for common pediatric cancers, including acute lymphoblastic leukemia (ALL) and brain tumors; yet, the life-saving treatments for these cancers place survivors at heightened risk for sustained cognitive effects. Longitudinal research has shown that the cognitive burden of ALL and pediatric brain tumors often consists of impairments in attention, working memory, and executive functioning, which can result in long-term disruption to daily living, socialization, academic achievement, and quality of life. Few non-pharmacological interventions exist to ameliorate these cognitive late effects. EndeavorRx, an FDA-approved electronic attentional-control training program, may be one intervention to help remediate executive functioning difficulties experienced by survivors. Although the program has been efficacious for youth with Attention-Deficit/Hyperactivity Disorder (ADHD), it has not yet been tested among survivors of childhood ALL or brain tumor. We propose to assess the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a pilot randomized, controlled trial. Survivors of ALL or brain tumor who are between the ages of 8 and 16 and have been off-therapy for at least one year will be included. The goal is to enroll and screen approximately 50 survivors across three pediatric oncology centers, in order to identify 40 participants with attention difficulties who will be randomized to one of two treatment arms. Participants will be assigned to either the EndeavorRx intervention, which includes 25-30 minute sessions per day, 5 days per week, for one month, or an active control condition of the same duration and intensity. Patients will undergo neurocognitive testing pre- and post-intervention, and parents will complete questionnaires regarding their child's functioning. It is hypothesized that this attentional-control training program will be both acceptable and feasible, with sufficient enrollment, positive satisfaction ratings, and acceptable treatment adherence. It is also anticipated that participants will show increases in performance-based and parent-rated attention, as compared to those in the active control condition.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EndeavorRx

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).

Group Type: EXPERIMENTAL

EndeavorRx

Intervention Type: 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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Control video game

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Hardy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Hardy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Children's National Hospital

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

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Hardy, Ph.D.

Role: CONTACT

sjhardy@childrensnational.org

202-476-5000

Facility Contacts

Steven Hardy, PhD

Role: primary

sjhardy@childrensnational.org

202-476-5000

Other Identifiers

R21CA261877

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000150

Identifier Type: -

Identifier Source: org_study_id