Feasibility/Acceptability of Attentional-Control Training in Survivors

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.

• Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of training [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Baseline and end of training (+4 weeks)]
• 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) [Срок оценки: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)]
• 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 [Срок оценки: Baseline and end of training (+4 weeks)]
• 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 [Срок оценки: Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)]