Acupressure for Persistent Cancer Related Fatigue

描述（由申请人提供）：今天有超过200万乳腺癌幸存者。持续性癌症相关疲劳（PCRF）是一种疲惫或厌倦的状态，是乳腺癌（BC）幸存者经历的最常见和最令人痛苦的症状之一。在诊断的前5年内，BC幸存者的显著PCRF率范围为30%至82%。PCRF与生活质量下降、睡眠质量下降和抑郁症有关。此外，BC幸存者诊断时低水平疲劳的主观报告预测无复发时间（风险比[RR] 1.32，95%置信区间[CI] 1.13-1.54）和总生存期（RR 1.23，95%CI 1.05-1.44）较长。因此，减少PCRF可能对妇女的生活质量和生存产生积极影响。PCRF的治疗选择很少，这些治疗需要训练有素的从业人员，成本高昂，给患者带来相当大的负担，或者具有不可接受的副作用。 穴位按摩是一种来自针灸的技术，是中国传统医学的一部分。在穴位按摩中，通过手、肘或各种设备对穴位施加物理压力以治疗疾病。初步研究表明，自我管理穴位按摩可以显着降低癌症幸存者的PCRF高达70%。穴位按摩也可以对癌症患者和其他慢性病患者的睡眠质量产生积极影响。我们已经进行了一项试点临床试验的穴位按摩的PCRF。在该试验中，我们观察到两个穴位按压公式，放松和刺激穴位按压的差异效应，两者都降低了PCRF，放松具有显着更大的效果。自我管理穴位按摩是一种无毒和廉价的治疗，需要最少的指导。穴位按摩也需要很少的努力和时间的一部分，病人成功地完成。因此，穴位按摩似乎是一个有前途的治疗PCRF和相关症状。 因此，我们提出了一个单盲，安慰剂对照研究，以检查两个相对的穴位按摩治疗的具体效果相比，标准的护理。本研究将在完成癌症治疗后至少12个月的375名BC幸存者中进行，中度至重度PCRF，将其随机分配至3组之一：（1）放松穴位按摩[RA];刺激穴位按摩[SA];或标准护理6周，随后为4周洗脱期。我们的主要目的是检查6周RA与SA或标准治疗相比对疲劳的影响，评估方法为：（1）使用简明疲劳量表进行每周自我报告;（2）活动记录仪上的客观日间体力活动;或（3）使用视觉模拟量表每天评估4次疲劳模式。次要终点包括检查两种穴位按压方案或标准护理对睡眠质量的影响，以及在临床环境中实施穴位按压所需的重要动力学参数;主要是6周治疗期间穴位按压对疲劳和睡眠影响的起效时间，以及4周洗脱期间RA和SA的作用持续时间。 公共卫生相关性：今天有超过200万乳腺癌幸存者，持续性癌症相关疲劳（PCRF）是一种疲惫或厌倦的状态，是乳腺癌（BC）幸存者经历的最常见和最令人痛苦的症状之一。本研究将探讨一种低成本和安全的治疗方法，来自中国传统医学，自我管理穴位按摩，治疗疲劳的BC幸存者。减少这些妇女的疲劳有能力提高她们的生活质量，并可能延迟或预防BC复发。

DESCRIPTION (provided by applicant): There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range from 30% to 82% within the first 5- years of diagnosis. PCRF is associated with decreased quality of life, decreased sleep quality and depression. Also, subjective reports of low levels of fatigue at diagnosis in BC survivors predict longer recurrence-free (risk ratio [RR] 1.32, 95% confidence interval [CI] 1.13-1.54) and overall survival (RR 1.23, 95%CI 1.05-1.44). Consequently, decreasing PCRF could have a positive impact on women's quality of life and on survival. There are few treatment options for PCRF and these treatments require the availability of a trained practitioner, are associated with significant costs, pose a sizeable burden for the patient, or have unacceptable side-effects. Acupressure is a technique derived from acupuncture, a component of Traditional Chinese Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand, elbow, or with various devices to treat disease. Pilot studies have demonstrated that self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer survivors. Acupressure can also have positive effects on sleep quality in cancer patients and other chronically ill populations. We have performed a pilot clinical trial of acupressure in PCRF. In that trial we observed differential effects of two acupressure formulas, relaxation and stimulatory acupressure, both of which reduced PCRF, with relaxation having a significantly greater effect. Self-administered acupressure is a non-toxic and inexpensive treatment that requires minimal instruction. Acupressure also requires little effort and time on the part of the patient to successfully complete. Thus, acupressure appears to be a promising treatment for PCRF and associated symptoms. As such, we propose a single-blind, placebo controlled study to examine the specific effect of two opposing acupressure treatments compared to standard of care. This study would be conducted in 375 BC survivors at least 12 months after completion of cancer treatments, with moderate to severe PCRF, who will be randomized to one of 3 groups: (1) relaxation acupressure [RA]; stimulating acupressure [SA]; or standard of care for 6-weeks followed by a 4-week washout period. Our primary aim is to examine the effect of 6-weeks of RA compared to SA or standard of care on fatigue as assessed by: (1) weekly self-report using the Brief Fatigue Inventory; (2) objective daytime physical activity on actigraph; or (3) fatigue patterns assessed 4-times daily using a visual analog scale. Secondary endpoints include the examination of the two acupressure regimes or standard of care on sleep quality, and on important kinetic parameters required for implementation of acupressure in a clinical setting; mainly the time to onset for effects of acupressure on fatigue and sleep during the 6-week treatment period and the duration of effect of RA and SA during the 4-week washout period. PUBLIC HEALTH RELEVANCE: There are over 2 million breast cancer survivors today and persistent cancer-related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. This study will examine a low cost and safe treatment derived from Traditional Chinese Medicine, self- administered acupressure, to treat fatigue in BC survivors. Decreasing fatigue in these women has the ability to improve their quality of life and possibly delay or prevent BC recurrence.