Massage for Prostate Cancer-Related Fatigue

今天在美国有超过1550万癌症幸存者，人们越来越关注质量 癌症治疗后的生活。癌症相关疲劳（CRF），一种持续的，主观的身体感觉， 与癌症或其治疗相关的情绪和/或认知衰竭与最近的 活动，是最常见的，也是癌症患者中最具破坏性的症状之一。CRF 可以在癌症治疗完成后持续数月或数年。前列腺癌（PCa）是最常见的 癌症在男性和有最高的医疗保险支出的任何癌症，影响老年男性。现代剪裁 治疗方案导致预期寿命延长，这导致与治疗相关的发病率， 不良副作用，包括心理困扰、疼痛和CRF。这个R21将研究治疗 瑞典按摩疗法（SMT）治疗PCa CRF的生物学效应，是我们研究的扩展。 在患有CRF的乳腺癌幸存者中完成的研究表明，SMT在临床上产生， 疲劳和生活质量（QOL）的统计学显著改善。一组同质的PCa幸存者 CRF患者（每组n=15）将被随机分配至三种条件之一：每周一次SMT治疗6周， 每周一次的轻度接触（LT）或6周的等待列表控制（WLC）条件。完成的受试者 将在末次研究访视后6周和12周随访SMT或LT的CRF持续变化。我们 假设SMT在改善PCa患者疲劳、情绪和QOL方面具有临床意义获益 患者，这将与可能导致CRF的生理参数的有利变化相关 并可能影响疾病进展。主要目的：进行初步研究，以确定 6周的SMT干预是否会降低接受过两次放疗的PCa幸存者的CRF 和雄激素剥夺疗法。次要目的：确定假设的CRF降低是否 SMT与慢性炎症相关的特异性免疫系统因子的调节有关。 探索性目的：1）确定SMT是否改善自我报告的疲劳，QOL，抑郁症， 根据患者报告结局（分别）评估，焦虑显著高于LT或WLC 测量系统（PROMIS）疲劳量表、生活质量、享受和满意度问卷 - 简式（Q-LES-Q）、抑郁症状快速量表-自我报告（QIDS-SR 16）和 GAD-7。2)通过以下方式收集关于6周SMT与LT对CRF的持续作用的初步数据： 干预后6周和12周测量MFI和PROMIS疲劳量表评分。这 研究将提供初步数据，证明SMT是缓解CRF的有效干预措施， 一组PCa幸存者，这种作用是由关键的促炎和抗炎细胞因子的变化介导的， 并且SMT改善了QOL和情绪症状。

With over 15.5 million cancer survivors today in the United States, increased attention is being given to quality of life after cancer treatment. Cancer-related fatigue (CRF), a persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity, is the most common, and one of the most devastating symptoms among patients with cancer. CRF can persist for months or years after cancer therapy is completed. Prostate cancer (PCa) is the most prevalent cancer in men and has the highest Medicare expenditure of any cancer that affects older men. Modern tailored treatment regimens have resulted in longer life expectancy, which lead to treatment related morbidity and adverse side effects, including psychological distress, pain and CRF. This R21 will investigate the therapeutic and biological effects of Swedish Massage Therapy (SMT) for CRF in PCa and is an extension of our completed study in breast cancer survivors with CRF demonstrating that SMT produces clinically and statistically significant improvements in fatigue and quality of life (QOL). A homogenous group of PCa survivors with CRF (n=15 per group) will be randomized to one of three conditions: 6 weeks of once-weekly SMT, 6 weeks of once-weekly Light Touch (LT), or a 6 week wait list control (WLC) condition. Subjects that complete SMT or LT will be followed up for persistent changes in CRF at 6 and 12 weeks after the last study visit. We hypothesize that SMT will have a clinically meaningful benefit in improving fatigue, mood, and QOL in PCa patients, and that this will correlate with favorable changes in physiological parameters that may underlie CRF and potentially impact disease progression. Primary Aim: To conduct a preliminary study to determine whether a 6-week SMT intervention decreases CRF among PCa survivors who have received both radiation and androgen deprivation therapy. Secondary Aim: To determine whether the hypothesized decrease in CRF with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. Exploratory Aims: 1) To determine whether SMT improves self-reported fatigue, QOL, depression, and anxiety significantly more than LT or WLC, as assessed (respectively) by the Patient-Reported Outcomes Measurement System (PROMIS) Fatigue Scale, the Quality of Life, Enjoyment, and Satisfaction Questionnaire – short form (Q-LES-Q), the Quick Inventory of Depressive Symptoms – Self-Report (QIDS-SR16), and the GAD-7. 2) To gather preliminary data about the sustained actions of 6 weeks of SMT versus LT on CRF, by measuring MFI and PROMIS Fatigue Scale scores at 6 weeks and 12 weeks after the intervention. This research will provide preliminary data demonstrating that SMT is an effective intervention for mitigating CRF in a group of PCa survivors, that this effect is mediated by changes in key pro- and anti-inflammatory cytokines, and that SMT improves QOL and mood symptoms.