Management of Cancer-Related Fatigue and Sleep Quality

描述（由申请人提供）：症状管理研究正在发生一个重要的转变，即检查症状群而不是单一症状。该研究的总体目标是通过检查对癌症治疗期间常见的两种目标症状（疲劳和失眠）的干预效果来扩展我们对症状管理的科学理解。我们还将检查干预对两种相关症状的影响，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，使我们能够测试针对失眠和疲劳的附加价值的假设，以及目标和相关症状的聚类过程的基础。本研究的具体目的是：1)测试疲劳/睡眠联合干预对疲劳和失眠目标症状和功能表现的疗效；2)检验改善睡眠质量在干预对疲劳影响中的中介作用程度；3)检查疲劳、失眠、疼痛、抑郁和功能表现之间的关系，对癌症治疗期间这些常见症状的聚类过程产生假设。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相等的对照组。该研究将在两个临床地点实施，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和对照组。感兴趣的主要结局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，功能表现，生活质量的一个方面，将进行评估。研究者将使用传统的重复测量方差分析来检验干预的有效性。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被干预导致的睡眠质量改善所解释。将使用多种统计技术来开发和探索可以解释被视为集群的症状之间的协变的模型。

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.