Management of Cancer-Related Fatigue and Sleep Quality

癌症相关疲劳和睡眠质量的管理

• 批准号: 6737451
• 负责人: ANDREA M BARSEVICK
• 金额: $ 59.16万
• 依托单位: FOX CHASE CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-02-15 至 2007-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6737451
• 关键词: cancer complication; cancer pain; clinical research; depression; fatigue; human subject; interview; medical complication; neoplasm /cancer therapy; questionnaires; sleep disorders

DESCRIPTION (provided by applicant): An important shift is now occurring in symptom management research to examine symptom clusters rather than single symptoms. The overall aim of the proposed research is to extend our scientific understanding of symptom management by examining the effect of an intervention for two target symptoms commonly reported during cancer treatment, fatigue and insomnia. We will also examine the effect of the intervention on two related symptoms, pain and depression, that are not targeted by the intervention. The investigators will extend the science through the design that allows us to test hypotheses about the added value of targeting insomnia, as well as fatigue, and about the process that underlies the clustering of the target and related symptoms. The specific aims of the proposed research are to: 1) test the efficacy of a combined fatigue/sleep intervention on the target symptoms of fatigue and insomnia and on functional performance; 2) examine the degree to which improved sleep quality mediates the effect of the intervention on fatigue; 3) examine the relationships among fatigue, insomnia, pain, depression, and functional performance to generate hypotheses about the processes underlying clustering of these commonly reported symptoms during cancer treatment. The proposed research will use an experimental design to compare an individual management plan for fatigue/sleep with a control group that equates for time and attention. The study will be implemented in two clinical sites including an academic health science center (Barrett Cancer Center of the University of Cincinnati) and a comprehensive cancer center (Fox Chase Cancer Center in Philadelphia). Participants will be randomly assigned to the intervention or the control group. The major outcomes of interest include the target symptoms of fatigue and insomnia and the related symptoms of pain and depression. In addition, functional performance, a dimension of quality of life, will be evaluated. The investigators will use traditional repeated measures ANOVA to test the efficacy of the intervention. Multiple regression analysis will be used to test the mediation hypothesis in which the relationship between the intervention and fatigue is partially accounted for by the improvement in sleep quality due to the intervention. Multiple statistical techniques will be used to develop and explore models that could explain covariation among symptoms that are seen as clusters.

描述（由申请人提供）：一个重要的转变，现在正在发生在症状管理研究，以检查症状群，而不是单一的症状。拟议研究的总体目标是通过检查癌症治疗期间通常报告的两种目标症状（疲劳和失眠）的干预效果，扩展我们对症状管理的科学理解。我们还将研究干预对两种相关症状的影响，即疼痛和抑郁，这两种症状不是干预的目标。研究人员将通过设计来扩展科学，使我们能够测试有关针对失眠和疲劳的附加值的假设，以及目标和相关症状聚类的基础过程。拟议研究的具体目的是：1）测试疲劳/睡眠综合干预对疲劳和失眠的目标症状以及功能表现的有效性; 2）检查改善睡眠质量在多大程度上介导了干预对疲劳的影响; 3）检查疲劳、失眠、疼痛、抑郁之间的关系，和功能表现，以产生关于癌症治疗期间这些通常报告的症状的聚类的潜在过程的假设。拟议的研究将使用实验设计来比较疲劳/睡眠的个人管理计划与时间和注意力等同的对照组。该研究将在两个临床中心实施，包括一个学术健康科学中心（辛辛那提大学巴雷特癌症中心）和一个综合癌症中心（费城福克斯蔡斯癌症中心）。参与者将被随机分配到干预组或对照组。关注的主要结果包括疲劳和失眠的目标症状以及疼痛和抑郁的相关症状。此外，还将评价功能表现，这是生活质量的一个方面。研究者将使用传统的重复测量方差分析来测试干预的有效性。多元回归分析将用于检验中介假设，其中干预与疲劳之间的关系部分归因于干预导致的睡眠质量改善。将使用多种统计技术来开发和探索模型，这些模型可以解释被视为集群的症状之间的协变。