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%的癌症患者在癌症治疗过程中的某个时间点经历CRF，77%的乳腺癌患者在放射治疗期间报告疲劳。CRF对患者的健康相关生活质量和日常生活活动具有深远影响，包括睡眠障碍增加、工作相关活动困难、肌无力和休闲活动减少。CRF的有效治疗将使大量癌症患者受益。我们的研究小组收集的初步数据表明，极性疗法（PT）是一种有效的，非侵入性的干预措施，以减轻CRF。我们对15名接受乳腺癌放疗的CRF女性的调查显示，与仅接受标准治疗的女性相比，接受单一PT治疗的女性的疲劳程度在统计学上显著降低（p <0.05）。接受PT治疗的10例患者中有8例报告疲劳改善，但仅接受标准治疗的5例患者中有1例报告疲劳改善。目前的申请是一项试点研究，通过提供关于PT在减少CRF、改善健康相关生活质量和改善乳腺癌放疗患者睡眠质量方面的疗效的额外数据，扩展这些初步发现。此外，本初步研究旨在完善程序和方法，提供样本量估计，并帮助在计划的R 01提交中进行随访研究的中介和调节分析的先验设计。 该研究是一项3臂随机临床试验，有60名正在接受乳腺癌放射治疗的患者，他们正在经历疲劳。第1组：患者（非干预对照组）将接受标准临床护理。第2组：患者（活性对照组）将接受标准临床护理加3次瑞典式按摩，以控制触摸和个人注意力。第3组：患者将接受标准临床治疗加3种PT治疗。患者将接受为期26天的研究，包括每日放射治疗。将在基线和随后的三次干预后评估中确定疲劳、健康相关生活质量和睡眠质量。除了睡眠/疲劳日记外，在整个26天研究期间将使用体动记录仪，以提供睡眠和疲劳的客观测量。预期的结果可能在CRF的治疗和研究中具有临床、方法学和理论应用，CRF是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.