FAACS: Feasibility/Acceptability of Attentional-Control Training in Survivors

FAACS：幸存者注意力控制训练的可行性/可接受性

• 批准号: 10684249
• 负责人: Steven Hardy
• 金额: $ 21.1万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10684249
• 关键词: Academic achievement; Acute Lymphocytic Leukemia; Address; Affect; Age; Attention; Attention deficit hyperactivity disorder; Behavior; Boston; Brain Neoplasms; Central Nervous System; Child; Childhood Acute Lymphocytic Leukemia; Childhood Brain Neoplasm; Clinical Trials; Cognitive; Cognitive remediation; Compensation; Cranial Irradiation; Data; Development; Disease; Electronics; Enrollment; Environment; Excision; FDA approved; Family; Goals; Home; Impairment; Intervention; Intervention Studies; Late Effects; Learning; Letters; Life; Malignant Childhood Neoplasm; Measures; Methotrexate; Outcome; Parents; Participant; Patients; Pediatric Oncology; Performance; Persons; Pilot Projects; Population; Quality of life; Questionnaires; Radiation therapy; Randomized; Randomized, Controlled Trials; Regulation; Research; Risk; Schools; Short-Term Memory; Site; Socialization; Structure; Survival Rate; Survivors; Tablet Computer; Testing; Thinking; Time; Training; Training Programs; Vocation; Youth; acceptability and feasibility; active control; active control group; attentional control; blood-brain barrier crossing; blood-brain tumor barrier; cancer therapy; chemotherapy; childhood cancer survivor; cognitive ability; cognitive function; cognitive load; cognitive skill; cognitive training; cohort; compliance behavior; design; digital; efficacy trial; executive function; experience; functional improvement; improved; interest; neural; neurocognitive test; performance based measurement; post intervention; programs; randomized trial; satisfaction; skills; social relationships; spelling; technical report; treatment adherence; treatment effect

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.

项目摘要/摘要 常见的儿童癌症，包括急性淋巴细胞白血病(ALL)和 脑瘤；然而，对这些癌症的挽救生命的治疗使幸存者面临更高的风险， 认知效应。纵向研究表明，ALL和儿童脑肿瘤的认知负担 可能包括注意力、工作记忆和执行功能的损害，这会导致长期的 扰乱日常生活、社交、学业成就和生活质量。很少有非药物性的 存在改善这些认知后遗症的干预措施，但结果令人振奋。最多的 被广泛研究的干预，Cogmed，是一种电子认知训练计划，已被证明 改善了工作记忆，但并没有导致广泛的功能改善。因此，它可能是一个多- 需要领域方法来将治疗效果推广到现实世界的功能。努力，FDA- 批准的电子注意控制训练计划，可能是一种帮助补偿 幸存者经历的执行功能困难。尽管这项计划对年轻人很有效 对于注意力缺陷/多动障碍(ADHD)，它还没有在童年幸存者中进行测试 要么是ALL，要么是脑瘤。因此，提出了一项试点随机对照试验来评估其可行性， 奋进的可接受性和初步疗效。ALL或脑瘤的幸存者年龄在 8岁和16岁，并已停止治疗至少一年的将包括在内。目标是招收40名学生 三个儿科肿瘤学中心的参与者。患者将参加奋进计划 干预，包括每天25-30分钟的会议，每周5天，为期一个月，或活动 控制条件。患者将在干预前后接受神经认知测试，父母将 填写有关其子女功能的完整问卷。据推测，这种注意力控制 培训计划将是可接受的和可行的，有足够的招生人数，积极的满意度， 以及至少80%的治疗依从性。预计参与者将在以下方面出现增长 与主动控制条件下的注意相比，基于表现的注意和父母等级的注意。这些 这些结果将对我们对奋进的效用进行概念化是必不可少的，并将为更大规模的随机 对这一培训计划的有效性进行了试验。综上所述，这项初步研究将对 为儿童ALL和脑瘤幸存者制定认知补救方案。