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

减轻儿科 ALL 治疗对睡眠影响的预防性护理方法

• 批准号: 10370378
• 负责人: Kira O. Bona
• 金额: $ 8.9万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10370378
• 关键词: Acute; Acute Lymphocytic Leukemia; Address; Affect; Antineoplastic Protocols; Anxiety; Behavioral; Cancer Patient; Caring; Chemotherapy-Oncologic Procedure; Child; Childhood; Childhood Acute Lymphocytic Leukemia; Chronic Insomnia; Clinical; Clinical trial protocol document; Coping Skills; Dana-Farber Cancer Institute; Data; Development; Diabetes Mellitus; Disease; Early Intervention; Educational Intervention; Electronics; Face; Family; Food; Goals; Health; Household; Housing; Impairment; Income; Initial Insomnia; Interdisciplinary Study; Intervention; Intervention Studies; Interview; Knowledge; Late Effects; Life; Long-Term Survivors; Longitudinal Studies; Maintenance Therapy; Malignant Childhood Neoplasm; Malignant Neoplasms; Medical; Mental Depression; Mental disorders; Modeling; Monitor; Morbidity - disease rate; Multicenter Trials; Obesity; Outcome; Parents; Patients; Pediatric Oncology; Pediatric cohort; Pediatrics; Personal Satisfaction; Play; Population; Prevention program; Preventive; Preventive care; Protocols documentation; Publishing; Reporting; Resources; Risk; Risk Factors; Role; Sampling; Savings; Schools; Severities; Sleep; Sleep Deprivation; Sleep Disorders; Sleep disturbances; Sleeplessness; Socioeconomic Status; Standardization; Stress; Structure; Survival Rate; Symptoms; Thinking; Translating; Transportation; Treatment-Related Cancer; acceptability and feasibility; actigraphy; arm; cancer therapy; care delivery; chemotherapy; clinical care; clinical practice; comorbidity; design; diaries; effective intervention; evidence base; falls; feasibility trial; federal poverty level; improved; improved outcome; innovation; leukemia treatment; low socioeconomic status; novel; patient population; poor sleep; prevent; preventive intervention; programs; psychosocial; response; sleep behavior; socioeconomics; therapy design; treatment effect; treatment risk

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.

项目摘要 超过50%的儿科癌症患者报告睡眠有问题，其特征是失眠障碍 症状。这导致相当大的身体和心理社会病态，包括行为 调节失调、焦虑和抑郁增加、肥胖和早期糖尿病。尽管总体上有证据 儿科学表明，预防性父母教育干预在改善儿童状况方面非常有效 睡眠和家庭健康，目前还没有公开发表的关于旨在预防或 减少癌症治疗的这种普遍的后遗症。基于我们在儿童癌症早期发现的基础上 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 制定提供早期干预的失眠预防计划。急性淋巴细胞性白血病 (ALL)是最常见的儿童癌症，在标准化背景下总存活率为90% 众所周知，化疗方案会扰乱睡眠。因此，所有患者都是理想的患者群体。 其中，首先制定这样一种干预措施的人绝大多数将是长期幸存者。从他们的生活开始- 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 睡眠中断对睡眠问题的严重程度和持续时间起着至关重要的作用。我们的 多学科研究团队将利用Dana-Farber癌症统一的护理提供环境 研究所所有联盟临床试验方案16-001，包括其史无前例的母公司-报告 社会经济状况(SES)数据，制定有针对性的失眠预防干预措施 生活在低社会保障家庭的儿童的需要。我们的具体目标是：(1)确定可修改的睡眠 儿童ALL患者在维持治疗期间的行为；(2)发展一种预防性失眠 减少儿童ALL治疗对睡眠的负面影响的干预措施；(3)评估可接受性 以及新型干预措施的可行性。我们将在一个月内进行预防性干预的单臂试验 N=30个低SES儿童ALL患者家系样本的可接受性和可行性 新的协议。这将是我们迈向下一步目标的关键第一步，我们的目标是进行全面的 多中心试验。失眠是儿科癌症患者的一个已知问题，通常在 在癌症治疗结束后，这种疾病可能会持续数十年。从这一创新中获得知识 提案将改变目前的模式，即失眠是治疗大多数失眠的预期迟发效应 儿科所有患者。我们致力于临床护理模式：预防疾病胜过预防疾病 在疾病临床表现出来后，集中资源进行治疗。“通过将证据转化为 对于儿童癌症患者的临床实践，我们可以显著改善儿童的健康结局 他们已经因为癌症治疗而面临长期并存的风险。