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的症状。这项拟议研究的总体目标是通过检查对癌症治疗中常见的两种目标症状--疲倦和失眠--的干预效果，扩大我们对症状管理的科学理解。我们还将检查干预对两个相关症状--疼痛和抑郁--的影响，这两个症状不是干预的目标。研究人员将通过设计来扩展科学，使我们能够测试关于靶向失眠和疲劳的附加值的假设，以及关于靶点聚集和相关症状的基础过程的假说。拟议研究的具体目的是：1)测试疲劳/睡眠联合干预对疲劳和失眠的目标症状以及功能表现的有效性；2)检查睡眠质量的改善在多大程度上调节了干预对疲劳的影响；3)检查疲劳、失眠、疼痛、抑郁和功能表现之间的关系，以产生关于癌症治疗期间这些常见症状聚集的潜在过程的假设。这项拟议的研究将采用实验设计，将个人的疲劳/睡眠管理计划与等同于时间和注意力的对照组进行比较。这项研究将在两个临床地点实施，包括学术健康科学中心(辛辛那提大学巴雷特癌症中心)和综合癌症中心(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。令人感兴趣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，还将评估生活质量的一个维度--功能表现。调查人员将使用传统的重复测量方差分析来检验干预的效果。多元回归分析将被用来检验中介假说，在该假说中，干预和疲劳之间的关系部分地解释了干预所带来的睡眠质量的改善。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性。

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.