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.

项目摘要超过50％的小儿癌症患者报告睡眠问题，其特征是失眠症症状。这导致了相当大的身体和社会心理发病率，包括行为失调，焦虑和抑郁，肥胖和早期糖尿病。尽管一般证据儿科证明预防性父母教育干预措施在改善儿童方面非常有效睡眠和家庭福祉，没有针对预防或减少这种普遍的癌症治疗后期作用。以我们的发现为基础治疗，不知所措的父母员工短期应对策略破坏了长期睡眠，我们建议制定一个提供早期干预的预防失眠计划。急性淋巴细胞白血病（全部）是最常见的儿童癌症，在标准化的背景下，总生存率为90％已知会干扰睡眠的化学疗法方案。因此，所有患者都是理想的患者人群鉴于绝大多数的绝大多数将首先发展这种干预措施。由于他们的生活 - 节省癌症治疗方案无法改变，孩子及其家人如何应对这些医学睡眠中断在严重的急性睡眠问题和持续时间的严重程度中起着至关重要的作用。我们的多学科研究团队将利用Dana-Farber Cancer的统一护理交付设置研究所所有财团临床试验方案16-001，包括其前所未有的父母报告社会经济地位（SES）数据，以开发针对特定的预防干预措施居住在低调家庭中的儿童的需求。我们的具体目的是：（1）确定可修改的睡眠在维持治疗期间，小儿同类中所有患者的行为；（2）发展预防性失眠干预措施减少了小儿所有治疗对睡眠的负面影响；（3）评估可接受性和新干预的可行性。我们将对A中进行预防干预的单臂试验 n = 30家低SES儿科家族的样本所有患者，以确定可接受性和可行性新协议。这将成为我们目标下一步进行完全动力的关键第一步多中心试验。失眠是儿科癌症患者的已知问题，经常在癌症治疗结束后，可以持续数十年的治疗。来自这种创新的知识提案将改变当前的模型，即失眠是大多数治疗的预期治疗后期作用儿科所有患者。我们致力于临床护理模型：“预防疾病比将资源集中于治疗疾病在临床上显而易见的治疗。”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他们的癌症治疗，他们已经有长期合并症的风险。