Grant Number:	1R21CA261877-01A1 Interpret this number
Primary Investigator:	Hardy, Steven
Organization:	Children'S Research Institute
Project Title:	FAACS: Feasibility/Acceptability of Attentional-Control Training in Survivors
Fiscal Year:	2022

PROJECT SUMMARY/ABSTRACT 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 may consist of impairments in attention, working memory, and executive functioning, which results 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, but the results have been promising. The most widely studied intervention, Cogmed, is an electronic cognitive training program that has been shown to improve working memory, but has not resulted in broad functional improvement. Thus, it may be that a multi- domain approach is needed to generalize treatment effects to real-world functioning. Endeavor, an FDA- approved electronic attentional-control training program, may be one intervention to help compensate for the 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. Therefore, a pilot randomized controlled trial is proposed to assess the feasibility, acceptability, and preliminary efficacy of Endeavor. 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 40 participants across three pediatric oncology centers. Patients will participate in either the Endeavor intervention, which includes 25-30 minute sessions per day, 5 days per week, for one month, or an active control condition. 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 at least 80% treatment compliance. 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. These results will be essential to our conceptualization of the utility of Endeavor and will inform a larger randomized trial of the efficacy of this training program. Taken together, this pilot study will have important implications for the development of cognitive remediation options for survivors of childhood ALL and brain tumor.





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