A Preventive Care Approach to Mitigate the Impact of Pediatric ALL Treatment on Sleep

项目摘要 超过50%的儿童癌症患者报告他们的睡眠问题，其特征是失眠症 症状这导致了相当大的身体和心理疾病，包括行为 失调、增加的焦虑和抑郁、肥胖和早期糖尿病。尽管有证据表明 儿科学证明预防性家长教育干预措施在改善儿童健康方面非常有效 睡眠和家庭幸福，目前还没有发表的干预研究，旨在防止或 减少癌症治疗的这种普遍的晚期效应。基于我们的发现，在儿童癌症早期， 治疗，不堪重负的父母采用短期应对策略，扰乱长期睡眠，我们建议， 制定失眠预防计划，提供早期干预。急性淋巴细胞白血病 (ALL)是最常见的儿童癌症，在标准化的背景下，总生存率为90%。 化疗方案会干扰睡眠。因此，ALL患者是一个理想的患者人群， 鉴于绝大多数人将是长期幸存者，首先制定这种干预措施。因为他们的生活- 挽救癌症治疗方案不能改变，孩子和他们的家人如何应对这些医疗 睡眠中断在急性睡眠问题的严重程度和持续时间方面起着关键作用。我们 一个多学科的研究小组将利用丹娜-法伯癌症中心的统一护理提供环境， 研究所ALL联盟临床试验方案16-001，包括其前所未有的父母报告 社会经济地位（SES）数据，以制定针对特定人群的失眠预防干预措施。 生活在低社会经济地位家庭的儿童的需要。我们的具体目标是：（1）确定可改变的睡眠 儿童ALL患者队列在维持治疗期间的行为;（2）制定预防性失眠 减少儿童ALL治疗对睡眠的负面影响的干预措施;（3）评估 和新干预的可行性。我们将进行一项预防性干预的单臂试验， 样本为N=30个低SES儿童ALL患者家庭，以确定 新颖的方案。这将是我们下一步目标的关键第一步， 多中心试验免疫缺陷是儿科癌症患者的一个已知问题， 治疗，并可以持续几十年后，癌症治疗已经结束。从这个创新的知识 该提案将改变目前的模式，即失眠是大多数人治疗的预期晚期效应。 儿童ALL患者。我们致力于临床护理模式，即“预防疾病比 集中资源治疗临床上表现明显的疾病。”通过将证据转化为 儿童癌症患者的临床实践，我们可以显着改善儿童的健康结果 由于癌症治疗，他们已经处于长期合并症的风险中。

Project Summary Over 50% of pediatric cancer patients report problems with their sleep, characterized by insomnia disorder symptoms. This results in considerable physical and psychosocial morbidity, including behavioral dysregulation, increased anxiety and depression, obesity, and early diabetes. Despite evidence in general pediatrics demonstrating that preventive parental education interventions are highly effective at improving child sleep and family well-being, there have been no published studies of interventions designed to prevent or reduce this prevalent late effect of cancer therapy. Building on our findings that early on during a child’s cancer treatment, overwhelmed parents employ short-term coping strategies that disrupt long-term sleep, we propose to develop an insomnia prevention program that provides early intervention. Acute lymphoblastic leukemia (ALL) is the most common childhood cancer with overall survival rates of 90% in the context of standardized chemotherapy regimens that are known to disturb sleep. ALL patients thus are an ideal patient population in which to first develop such an intervention given the vast majority will be long-term survivors. Since their life- saving cancer treatment protocols cannot be altered, how the child and their family respond to these medical disruptions to sleep plays a critical role in how severe acute sleep problems are and how long they persist. Our multi-disciplinary research team will leverage the uniform care delivery setting of the Dana-Farber Cancer Institute ALL Consortium clinical trial Protocol 16-001, including its unprecedented parent-reported socioeconomic status (SES) data, to develop an insomnia-prevention intervention targeted to the specific needs of children living in low-SES households. Our specific aims are to: (1) identify modifiable sleep behaviors in a cohort of pediatric ALL patients during maintenance therapy; (2) develop a preventive insomnia intervention that reduces the negative impact of pediatric ALL treatment on sleep; (3) evaluate the acceptability and feasibility of the novel intervention. We will conduct a single-arm trial of the preventive intervention in a sample of N=30 families of low-SES pediatric ALL patients to determine the acceptability and feasibility of the novel protocol. This will serve as the critical first step to the next step of our goal to conduct a fully powered multi-center trial. Insomnia is a known problem for pediatric cancer patients that often develops during treatment and can persist for decades after cancer therapy has ended. Knowledge from this innovative proposal will shift the current model that insomnia is an expected late effect of treatment for the majority of pediatric ALL patients. We are committed to the clinical care model that “it is better to prevent diseases than to concentrate resources on treating diseases after they become clinically apparent.” By translating evidence into clinical practice for childhood cancer patients, we can significantly improve the health outcomes for children who are already at risk for long-term co-morbidities as a result of their cancer treatments.