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: 10458355
• 负责人: Steven Hardy
• 金额: $ 28.91万
• 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/10458355
• 关键词: Academic achievement; Acute Lymphocytic Leukemia; Address; Affect; Age; Attention; Attention deficit hyperactivity disorder; Behavior; Boston; Brain Neoplasms; Child; Childhood Acute Lymphocytic Leukemia; Childhood Brain Neoplasm; Clinical Trials; Cognitive; Cognitive remediation; Control Groups; Cranial Irradiation; Data; Disease; Enrollment; Environment; Excision; FDA approved; Family; Goals; Home; Impairment; Intervention; Intervention Studies; Late Effects; Learning; Letters; Life; Light; Malignant Childhood Neoplasm; Measures; Methotrexate; Neuraxis; Outcome; Parents; Participant; Patients; Pediatric Oncology; Performance; Persons; Pilot Projects; Population; Quality of life; Questionnaires; Radiation therapy; Randomized; Randomized Controlled Trials; Regulation; Research; Risk; Savings; Schools; Short-Term Memory; Site; Socialization; Structure; Survival Rate; Survivors; Tablet Computer; Testing; Thinking; Time; Training; Training Programs; Youth; acceptability and feasibility; active control; attentional control; base; blood-brain barrier crossing; cancer therapy; chemotherapy; childhood cancer survivor; cognitive ability; cognitive development; cognitive function; cognitive load; cognitive skill; cognitive training; cohort; compliance behavior; design; digital; efficacy trial; executive function; experience; functional improvement; improved; interest; neurocognitive test; performance based measurement; post intervention; programs; randomized trial; relating to nervous system; satisfaction; skills; social relationships; spelling; technical report; treatment adherence; treatment effect; tumor

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.

项目总结/摘要 常见儿科癌症的生存率正在增加，包括急性淋巴细胞白血病（ALL）和 脑肿瘤;然而，对这些癌症的挽救生命的治疗使幸存者处于持续的高风险之中。 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，这导致长期的 对日常生活、社交、学术成就和生活质量的破坏。非药物治疗很少 存在可以改善这些认知晚期效应的干预措施，但结果是有希望的。最 广泛研究的干预，Cogmed，是一种电子认知训练计划，已被证明， 改善工作记忆，但没有导致广泛功能改善。或许，这是一个多方面的问题。 需要领域方法来将治疗效果推广到现实世界的功能。奋进，一个FDA- 批准的电子注意力控制训练计划，可能是一种干预，以帮助补偿 幸存者经历的执行功能障碍。尽管该计划对年轻人有效， 注意力缺陷多动障碍（ADHD），它尚未在儿童幸存者中进行测试。 ALL或脑瘤。因此，拟进行一项初步随机对照试验，以评估其可行性， 奋进的可接受性和初步疗效。年龄介于以下的ALL或脑肿瘤幸存者 8岁和16岁，并且已经停止治疗至少一年。目标是招收40名 三个儿科肿瘤中心的参与者。患者将参加奋进 干预，包括每天25-30分钟的课程，每周5天，为期一个月，或 控制条件患者将在干预前后接受神经认知测试，父母将 填写关于孩子功能的问卷。据推测，这种注意力控制 培训计划既可接受又可行，有足够的报名人数，积极的满意度评级， 以及至少80%的治疗依从性。预计参加者的人数也将增加， 与主动控制条件下的注意力相比，基于表现的注意力和父母评定的注意力。这些 这些结果对于我们对奋进号实用性的概念化至关重要，并将为一个更大的随机 测试这个训练计划的效果。总之，这项试点研究将对以下方面产生重要影响： 为儿童ALL和脑肿瘤幸存者开发认知补救方案。