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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要超过 50% 的儿童癌症患者报告有睡眠问题，其特点是失眠症这会导致相当大的身体和心理发病率，包括行为。尽管有一般证据，但调节失调、焦虑和抑郁增加、肥胖和早期糖尿病。儿科研究表明，预防性家长教育干预措施对于改善儿童的健康状况非常有效睡眠和家庭福祉，目前还没有发表旨在预防或家庭幸福的干预措施的研究根据我们在儿童癌症早期的发现，减少癌症治疗的这种普遍的晚期效应。我们建议，在治疗过程中，不知所措的父母采用短期应对策略会破坏长期睡眠制定提供早期干预的失眠预防计划。 (ALL) 是最常见的儿童癌症，在标准化背景下总体生存率为 90% 因此，已知会干扰所有患者的化疗方案是理想的患者群体。鉴于绝大多数人将是长期幸存者，因此首先要制定这样的干预措施。保存癌症治疗方案不能改变，孩子及其家人如何应对这些医疗睡眠中断对于急性睡眠问题的严重程度及其持续时间起着至关重要的作用。多学科研究团队将利用丹娜—法伯癌症中心的统一护理服务环境研究所 ALL 联盟临床试验方案 16-001，包括其前所未有的家长报告失业状况（SES）数据，针对特定人群制定失眠预防干预措施我们的具体目标是：(1) 确定可改变的睡眠。一组儿科 ALL 患者在维持治疗期间的行为；(2) 形成预防性失眠减少儿科 ALL 治疗对睡眠的负面影响的干预措施；(3) 评估可接受性；我们将在一个试验中进行预防性干预的单臂试验。对 N = 30 个低 SES 儿童 ALL 患者家庭进行抽样，以确定该方案的可接受性和可行性新颖的协议将作为我们下一步目标的关键第一步，以实现全面的动力。多中心试验指出，失眠是儿科癌症患者的一个已知问题，通常在治疗期间出现。癌症治疗结束后可以持续数十年。该提案将改变目前的模式，即对于大多数人来说，失眠是治疗的预期后期效果我们致力于“预防疾病胜于治疗疾病”的临床护理模式。通过将证据转化为临床症状后集中资源来治疗疾病。” 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而已经面临长期合并症风险的人。