Clinical trial NCT05528939: Feasibility/Acceptability of Attentional-Control Training in Survivors
Official title: FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Pediatric ALL
Pediatric Brain Tumor
Attention Difficulties
Cognitive Deficit in Attention
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: St. Jude Children's Research Hospital
name: Children's Hospital of Philadelphia
name: George Washington University
name: National Cancer Institute (NCI)
First posted: 2022-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, randomized, active-control trial using a 1:1 randomization (stratified by diagnosis) to the intervention or a comparison digital activity.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility assessed by patient/family interest
timeFrame: Baseline
measure: Feasibility assessed by EndeavorRx training adherence rates
timeFrame: After completion of 4 weeks of EndeavorRx training
measure: Feasibility assessed by reports of technical ease-of-use and satisfaction
timeFrame: End of training (+4 weeks)
Secondary outcomes:
measure: Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of training
timeFrame: Baseline and end of training (+4 weeks)
measure: 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)
timeFrame: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
measure: Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at end of training
timeFrame: Baseline and end of training (+4 weeks)
measure: 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)
timeFrame: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
measure: Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at end of training
timeFrame: Baseline and end of training (+4 weeks)
measure: Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)
timeFrame: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
measure: Change from baseline executive functioning assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Cognitive Regulation Index (CRI) at end of training
timeFrame: Baseline and end of training (+4 weeks)
measure: Change from baseline executive functioning assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Cognitive Regulation Index (CRI) at end of training
timeFrame: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Steven Hardy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: