Polarity Therapy for Cancer-Related Fatigue

描述(由申请人提供)： 癌症相关性疲劳(CRF)是癌症及其治疗中最常见的副作用。我们的数据和文献表明，60%-96%的癌症患者在癌症治疗过程中的某个时候经历过CRF，77%的乳腺癌患者报告在放射治疗期间感到疲劳。慢性肾功能衰竭对患者的健康相关生活质量和日常生活活动能力有深远的影响，包括睡眠障碍增加，与工作相关的活动困难，肌肉无力，休闲活动减少。CRF的有效治疗将使大量癌症患者受益。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、非侵入性的缓解CRF的干预措施。我们对15名接受乳腺癌放射治疗的慢性肾功能衰竭患者的调查显示，与只接受标准治疗的女性相比，接受单一PT治疗的女性疲劳程度显著减少(p&lt；0.05)。据报道，在接受PT的10名患者中，有8名患者的疲劳有所改善，但仅接受标准护理的5名患者中只有1名。目前的应用是一项试点研究，通过提供更多关于PT在减少CRF、改善与健康相关的生活质量和改善接受乳腺癌放射治疗的患者的睡眠质量方面的有效性的数据，来扩展这些初步发现。此外，这项试点研究的目的是改进程序和方法，提供样本量估计，并帮助为计划中的R01提交的后续研究预先设计调解人和主持人分析。 这项拟议的研究是一项三臂随机临床试验，涉及60名正在接受放射治疗的乳腺癌患者，这些患者正在经历疲劳。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3个瑞典式按摩，以控制触摸和个人关注。手臂3：患者将接受标准的临床护理和3次PT治疗。患者将接受为期26天的研究，包括每天的放射治疗。疲劳、与健康相关的生活质量和睡眠质量将在基线和随后的三次干预后评估中确定。除了睡眠/疲劳日记外，还将在整个26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的治疗和研究中具有临床、方法学和理论上的应用，CRF是一种在放射治疗期间影响大多数癌症患者的症状。

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 cancer patients experience CRF at some point during their course of cancer treatment, and that 77% of breast cancer patients report fatigue during radiation treatment. CRF has a profound effect on patients' health-related quality of life and activities of daily living, including increased sleep disturbance, difficulties with work-related activities, muscle weakness, and reduction in leisure activity. An effective treatment for CRF would benefit a large number of cancer patients. Preliminary data gathered by our research team suggest that Polarity Therapy (PT) is an efficacious, non-invasive intervention for alleviating CRF. Our investigation of 15 women with CRF receiving radiation therapy for breast cancer showed a statistically significant (p < .05) reduction in fatigue in women who received a single PT treatment compared with women who received standard care alone. Improvement in fatigue was reported by 8 of 10 patients receiving PT, but only 1 of 5 patients receiving standard care alone. The current application is for a pilot study to extend these preliminary findings by providing additional data on the efficacy of PT for reducing CRF, improving health-related quality of life, and improving quality of sleep in patients receiving radiation therapy for breast 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 follow-up study in a planned R01 submission. The proposed study is a 3-arm randomized clinical trial with 60 patients undergoing radiation therapy for breast cancer who are experiencing fatigue. Arm 1: Patients (non-intervention control group) will receive standard clinical care. Arm 2: Patients (active control group) will receive standard clinical care plus 3 Swedish style massages to control for touch and personal attention. Arm 3: Patients will receive standard clinical care plus 3 PT treatments. Patients will be studied for a 26-day period encompassing daily radiation treatments. Fatigue, health-related quality of life, and quality of sleep will be determined at baseline and at three subsequent post-intervention assessments. In addition to a sleep/fatigue diary, actigraphy will be used during the entire 26-day study period to provide objective measures of sleep and fatigue. Anticipated results could have clinical, methodological, and theoretical application in the treatment and study of CRF, a symptom affecting most cancer patients during radiation therapy.