Acupressure for Persistent Cancer Related Fatigue

穴位按摩治疗持续性癌症相关疲劳

• 批准号: 8310781
• 负责人: RICHARD E HARRIS
• 金额: $ 44.9万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-03 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8310781
• 关键词: Activities of Daily Living; Acupressure; Acupuncture Points; Acupuncture procedure; Adverse effects; Aftercare; Area; Beds; Breast; Cancer Patient; Cancer Survivor; Chinese Traditional Medicine; Chronically Ill; Clinic; Clinical; Clinical Trials; Confidence Intervals; Devices; Diagnosis; Disease; Distress; Elbow; Equipment and supply inventories; Family; Fatigue; Hand; Impaired cognition; Instruction; Intervention; Kinetics; Malignant Neoplasms; Measures; Mental Depression; Nurses; Odds Ratio; Patient Self-Report; Patients; Pattern; Physical activity; Pilot Projects; Population; Quality of life; Randomized; Randomized Controlled Trials; Recurrence; Relaxation; Reporting; Self-Administered; Sleep; Sleep disturbances; Symptoms; Techniques; Time; Training; Visual; Woman; Work; Wrist; actigraphy; analog; arm; blind; cancer recurrence; cancer therapy; clinically significant; cost; design; diaries; experience; improved; indexing; malignant breast neoplasm; novel; placebo controlled study; pressure; prevent; primary outcome; psychosocial; public health relevance; standard of care; treatment duration

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.

描述（由申请人提供）：当今有超过 200 万乳腺癌幸存者。持续性癌症相关疲劳 (PCRF) 是一种疲倦或倦怠的状态，是乳腺癌 (BC) 幸存者最常见和最痛苦的症状之一。在诊断后的前 5 年内，BC 幸存者中显着 PCRF 的发生率为 30% 至 82%。 PCRF 与生活质量下降、睡眠质量下降和抑郁有关。此外，BC 幸存者诊断时疲劳程度较低的主观报告预测更长的无复发时间（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）。因此，减少 PCRF 可能会对女性的生活质量和生存产生积极影响。 PCRF 的治疗选择很少，并且这些治疗需要训练有素的执业医师，费用高昂，给患者带来相当大的负担，或者具有不可接受的副作用。 指压按摩是一种源自针灸的技术，针灸是中医的一部分。在穴位按摩中，用手、肘部或各种设备对穴位施加物理压力来治疗疾病。试点研究表明，自我穴位按摩可以使癌症幸存者的 PCRF 显着降低多达 70%。穴位按摩还可以对癌症患者和其他慢性病人群的睡眠质量产生积极影响。我们已经在 PCRF 中进行了穴位按摩的试点临床试验。在那次试验中，我们观察到两种穴位按摩公式（放松和刺激性穴位按摩）的不同效果，两者都降低了 PCRF，其中放松的效果明显更大。自我穴位按摩是一种无毒且廉价的治疗方法，需要最少的指导。穴位按摩也只需患者付出很少的努力和时间即可成功完成。因此，穴位按摩似乎是治疗 PCRF 及相关症状的一种有前途的治疗方法。 因此，我们提出一项单盲、安慰剂对照研究，以检查两种相反的穴位按摩治疗与标准护理相比的具体效果。这项研究将在完成癌症治疗至少 12 个月后的 375 名患有中度至重度 PCRF 的 BC 幸存者中进行，他们将被随机分为 3 组之一：(1) 放松穴位按摩 [RA]；刺激穴位按摩[SA]；或 6 周的标准护理，然后是 4 周的冲洗期。我们的主要目的是检查 6 周 RA 与 SA 或标准护理相比对疲劳的影响，评估方法如下：(1) 使用简短疲劳清单进行每周自我报告； (2) 活动记录仪上的客观白天体力活动； (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摩方案或睡眠质量护理标准，以及在临床环境中实施穴位按摩所需的重要动力学参数；主要是6周治疗期间针压对疲劳和睡眠的影响的起效时间以及4周冲洗期间RA和SA的作用持续时间。 公共卫生相关性：当今有超过 200 万乳腺癌幸存者，持续性癌症相关疲劳 (PCRF)（一种疲倦或疲倦的状态）是乳腺癌 (BC) 幸存者经历的最常见和令人痛苦的症状之一。本研究将探讨一种源自传统中医的低成本且安全的治疗方法，即自我穴位按摩，以治疗 BC 幸存者的疲劳。减少这些女性的疲劳可以改善她们的生活质量，并可能延迟或预防 BC 复发。