Feasibility of a mobile application for sleep and circadian rhythms in pediatric patients with acute lymphoblastic leukemia and their caregivers

急性淋巴细胞白血病儿科患者及其护理人员睡眠和昼夜节律移动应用程序的可行性

• 批准号: 10603223
• 负责人: Olivia Walch
• 金额: $ 27.36万
• 依托单位: ARCASCOPE, INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10603223
• 关键词: 15 year old; Acute Lymphocytic Leukemia; Address; Adult; Affect; Age; Behavior; Behavioral; Caregivers; Child; Childhood Acute Lymphocytic Leukemia; Chronic; Circadian Dysregulation; Circadian Rhythms; Clinical; Clinical Trials; Data; Diagnosis; Distress; Family; Fatigue; Feedback; Feeling; Foundations; Goals; Grant; Health; Impaired cognition; Individual; Intervention; Interview; Leukemia Acute Lymphoblastic Chemotherapy; Light; Lighting; Malignant Neoplasms; Moods; Oncology; Outcome; Parents; Patient Care; Patients; Periodicity; Phase; Population; Quality of life; Recommendation; Reporting; Research; Resources; Role; Services; Sleep; Sleep Disorders; Sleep disturbances; Small Business Technology Transfer Research; Sorting; Steroids; Survival Rate; Survivors; Symptoms; Testing; Time; Treatment Efficacy; Vulnerable Populations; Work; circadian; cognitive performance; common treatment; depressive symptoms; design; effective intervention; efficacy evaluation; evidence base; experience; feasibility trial; health related quality of life; improved; improved outcome; improvement on sleep; leukemia treatment; minimally invasive; mobile application; patient oriented; pediatric patients; phase II trial; primary caregiver; prospective; relapse risk; response; sleep quality; sleep quantity; success; technological innovation; tool; usability; wearable device

ABSTRACT Long-term survival rates for children diagnosed with acute lymphoblastic leukemia (ALL) currently exceed 90%. However, prolonged ALL chemotherapy, which lasts two to three years on average, is associated with significant fatigue and sleep disturbances in both children and their caregivers. In fact, patients and caregivers often identify excess fatigue and sleep disturbances as the most distressing symptoms experienced during ALL treatment. In addition to adversely impacting quality of life during treatment, fatigue and sleep problems may alter mood, result in long-term cognitive dysfunction, and potentially compromise treatment efficacy. Despite unfavorable fatigue and sleep being a pervasive problem in children with ALL and their caregivers, effective intervention options are limited. Therefore, there is a significant unmet clinical need to identify evidence-based, minimally invasive strategies to intervene and restore circadian rhythmicity in pediatric patients with ALL and their caregivers. Building upon our previous success developing mobile applications to address cancer-related fatigue in adult oncology populations, this proposal seeks to adapt a pilot mobile application to track sleep and circadian rhythms in patients with ALL and their caregivers. While many existing resources provide information on the importance of sleep duration, few highlight the role of circadian rhythms and light exposure. In particular, while numerous commercial wearables exist that can track sleep, few if any give personalized recommendations for how light exposure and other behaviors can be used to improve sleep, especially in populations that are likely to have highly disrupted sleep. The proposed project will leverage consumer wearable technology to conduct sleep and circadian analysis for children with ALL for the purposes of prescribing lighting and behavioral recommendations to help improve sleep in these patients. Moreover, we propose to extend the analysis and the prescriptions beyond the patients themselves, to their caregivers, improving outcomes for the entire family. Specifically, this Phase I STTR proposes two aims: 1) we will design a mobile app for reducing cancer-related fatigue in pediatric patients with ALL and their caregivers using a patient-centered approach refined with feedback from patient-caregiver dyads, and 2) we will conduct a usability study in a population of 16 patient-caregiver dyads to assess the feasibility of an app-delivered light and behavior-based intervention in this population. The results of this Phase I application will provide the foundation necessary to conduct a Phase II trial to assess the efficacy of the new app to reduce fatigue and improve sleep quality and duration in a large population of pediatric ALL patients and their caregivers. Ultimately, we anticipate this line of research will lead to the identification of a feasible, minimally invasive, effective intervention to address fatigue and sleep issues in this vulnerable population, leading to improvements in quality of life and outcomes.

摘要 急性淋巴细胞白血病（ALL）儿童的长期生存率目前超过 百分之九十然而，长期的ALL化疗，平均持续两到三年， 严重的疲劳和睡眠障碍的儿童和他们的照顾者。事实上，病人和护理人员 通常认为过度疲劳和睡眠障碍是ALL期间经历的最令人痛苦的症状， 治疗除了在治疗期间对生活质量产生不利影响外，疲劳和睡眠问题可能 改变情绪，导致长期认知功能障碍，并可能损害治疗效果。尽管 不利的疲劳和睡眠是ALL儿童及其照顾者普遍存在的问题， 干预选择有限。因此，有一个重大的未满足的临床需要，以确定循证， 干预和恢复ALL儿童患者昼夜节律的微创策略， 他们的照顾者。在我们之前成功开发移动的应用程序的基础上， 由于成年肿瘤人群的疲劳，该提案寻求调整试点移动的应用程序来跟踪睡眠， ALL患者及其护理人员的昼夜节律。虽然许多现有资源提供信息， 关于睡眠时间的重要性，很少有人强调昼夜节律和光照的作用。特别是， 虽然有许多商业可穿戴设备可以跟踪睡眠，但很少有个性化的 关于如何使用光照和其他行为来改善睡眠的建议，特别是在 睡眠受到严重干扰的人群。该项目将利用消费者 可穿戴技术，用于对ALL儿童进行睡眠和昼夜节律分析， 提供照明和行为建议，以帮助改善这些患者的睡眠。而且我们 建议将分析和处方扩展到患者本身之外，扩展到他们的护理人员， 改善整个家庭的结果。具体而言，第一阶段短期技术研究提出了两个目标：1）我们将设计 一个移动的应用程序，用于减少儿童ALL患者及其护理人员的癌症相关疲劳， 以病人为中心的方法，从病人照顾者的反馈完善，2）我们将进行一个 在16名患者-护理人员配对人群中进行的可用性研究，以评估应用程序提供的照明的可行性 和基于行为的干预。第一阶段申请的结果将提供 进行第二阶段试验以评估新应用程序减少疲劳的功效所需的基础， 改善大量儿童ALL患者及其护理人员的睡眠质量和持续时间。 最终，我们预计这一系列的研究将导致确定一个可行的，微创的， 有效的干预措施，以解决这一弱势群体的疲劳和睡眠问题， 改善生活质量和成果。