Polarity Therapy for Cancer-Related Fatigue

描述(由申请人提供)：癌症相关性疲劳(CRF)是癌症及其治疗最常见的副作用。我们的数据和文献表明，60%-96%的患者在治疗过程中的某个时候经历过CRF。CRF除了对健康相关的生活质量(HRQL)和日常生活能力产生深远影响外，还会导致睡眠障碍增加、与工作有关的活动困难、肌肉无力和休闲活动减少。目前，没有现有的数据支持对CRF的任何特定治疗的有效性。我们研究小组收集的初步数据表明，极性疗法(PT)是一种有效的非侵入性干预措施，可以缓解CRF。接受标准治疗、一次PT治疗或两次PT治疗的15名接受乳腺癌放射治疗的CRF女性报告称，与接受标准治疗的女性相比，单一PT治疗后疲劳感显著减少(p&lt；0.05)。在接受PT的10名患者中，有8名患者的疲劳得到改善，而在接受标准护理的5名患者中，只有1名报告疲劳有所改善。目前的应用是一项试点研究，将通过提供关于PT在减少CRF、改善HRQL和改善接受结直肠癌化疗的患者的睡眠质量(QOS)方面的有效性的初步数据来扩展这些先前的发现。此外，这项试点研究旨在改进程序和方法，提供样本量估计，并帮助为计划中的R01提交进行调解人和主持人分析的先验设计。目前的研究将采用三组随机临床试验设计，60名接受CRF治疗的结直肠癌患者接受辅助化疗。臂1：患者(非干预对照组)接受标准的临床护理。手臂2：患者(主动对照组)将接受标准的临床护理，外加2次颈、肩和手按摩治疗。手臂3：患者将接受标准的临床护理和2次PT治疗。患者将接受为期21天的研究，包括每周三次化疗输液。将在基线和两次干预后评估中评估疲劳、HRQL和QOS。除了睡眠/疲劳日记外，还将在整个21天的研究期间使用活动记录仪，以提供睡眠和疲劳的客观衡量标准。预期的结果可能在CRF的研究和治疗中具有临床、方法学和理论应用。

DESCRIPTION (provided by applicant): Cancer-related fatigue (CRF) is the most frequently reported side effect of cancer and its treatment. Our data and the literature suggest that 60 - 96% of patients experience CRF at some point during their course of treatment. In addition to its profound effect on health-related quality of life (HRQL) and activities of daily living, CRF can promote increased sleep disturbance, difficulties with work-related activities, muscle weakness, and reduction in leisure activity. At present, no extant data support the effectiveness of any specific treatment for CRF. Preliminary data gathered by our research team suggests that Polarity Therapy (PT) is an efficacious non-invasive intervention for alleviating CRF. Fifteen women with CRF receiving radiation therapy for breast cancer who received either standard care, one PT treatment or two PT treatments reported a statistically significant (p < .05) reduction in fatigue after a single PT treatment compared to women receiving standard care. The improvement in fatigue observed with PT was found in 8 of 10 patients receiving PT, with only 1 of 5 patients receiving standard care reporting improvement in fatigue. The current application is for a pilot study that will extend these previous findings by providing preliminary data on the efficacy of PT for reducing CRF, improving HRQL, and improving quality of sleep (QOS) in patients receiving chemotherapy for colorectal cancer. Additionally, this pilot study is designed to refine procedures and methods, provide a sample-size estimate, and aid in the a priori design of mediator and moderator analyses for a planned R01 submission. The current study will utilize a 3-Arm randomized clinical trial design with 60 patients experiencing CRF undergoing adjuvant chemotherapy for colorectal cancer. Arm 1: patients (non-intervention control group) will receive standard clinical care. Arm 2: patients (active control group) will receive standard clinical care plus 2 neck, shoulder and hand massage treatments. Arm 3: patients will receive standard clinical care plus 2 PT treatments. Patients will be studied for a 21-day period encompassing three weekly chemotherapy infusions. Fatigue, HRQL and QOS will be assessed at baseline and at two post-intervention assessments. In addition to a sleep/fatigue diary, actigraphy will be used during the entire 21-day study period to provide objective measures of sleep and fatigue. Anticipated results could have clinical, methodological, and theoretical application in the study and treatment of CRF.