Massage for Prostate Cancer-Related Fatigue

按摩治疗前列腺癌相关疲劳

• 批准号: 10290445
• 负责人: Mark Hyman Rapaport
• 金额: $ 39.21万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10290445
• 关键词: Affect; Anti-Inflammatory Agents; Anxiety; Area; Attention; Biological; Breast Cancer survivor; Cancer Etiology; Cancer Patient; Cancer Survivor; Caring; Chronic; Clinical; Clinical Oncology; Clinical Trials; Cognitive; Communities; Data; Development; Disease Progression; Distress; Emotional; Equipment and supply inventories; Evaluation; Expenditure; Exploratory/Developmental Grant; Family; Fatigue; Future; Immune system; Inflammation; Inflammatory; Interferon Type II; Interleukin-1 beta; Interleukin-10; Interleukin-6; Intervention; Lead; Life Expectancy; Light; Malignant Neoplasms; Malignant neoplasm of prostate; Massage; Measurement; Measures; Mediating; Medicare; Mental Depression; Modernization; Moods; Morbidity - disease rate; National Cancer Institute; Pain; Patient Outcomes Assessments; Patient Self-Report; Patients; Performance at work; Personal Satisfaction; Physical Function; Physiological; Plasma; Quality of life; Questionnaires; Radiation; Randomized; Research; Research Priority; Social Interaction; Symptoms; System; TNF gene; Therapeutic; Therapeutic Intervention; Touch sensation; Treatment Protocols; Treatment-Related Cancer; United States; Visit; Waiting Lists; Well in self; Work; anakinra; androgen deprivation therapy; base; cancer clinical trial; cancer therapy; cancer type; cognitive performance; cytokine; depressive symptoms; effective intervention; exhaustion; follow-up; improved; individualized medicine; men; mood symptom; older men; programs; prostate cancer survivors; psychological distress; response; satisfaction; side effect; treatment duration; treatment effect

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.

今天，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。癌症相关性疲劳(CRF)，一种持续的、主观的身体感觉， 与癌症或其治疗不成比例的情绪和/或认知衰竭 活动，是最常见的，也是癌症患者最具破坏性的症状之一。CRF 可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 在所有影响老年男性的癌症中，医疗保险支出最高。现代定制 治疗方案导致了更长的预期寿命，从而导致与治疗相关的发病率和 不良副作用，包括心理痛苦、疼痛和慢性肾功能衰竭。这架R21将调查治疗 瑞典推拿疗法(SMT)治疗前列腺癌CRF的生物学效应 在患有慢性肾功能衰竭的乳腺癌幸存者中完成的研究表明，SMT在临床和 在疲劳和生活质量(QOL)方面有统计上的显著改善。一群同质的PCA幸存者 有慢性肾功能衰竭的患者(每组15人)将被随机分为三种情况之一：每周一次的SMT治疗6周，6周 每周一次的数周轻触(LT)，或6周的等待列表控制(WLC)条件。完成课程的科目 在最后一次研究访问后6周和12周，将对SMT或LT进行随访，以了解CRF的持续变化。我们 假设SMT在改善PCa患者的疲劳、情绪和生活质量方面具有临床意义 这将与可能导致慢性肾衰的生理参数的有利变化相关。 并有可能影响疾病的发展。主要目的：进行初步研究，以确定 SMT干预6周是否降低了同时接受两种放射治疗的PCA幸存者的CRF 和雄激素剥夺疗法。次要目的：确定CRF假说的减少是否 SMT与慢性炎症相关的特定免疫系统因素的调节。 探索性目标：1)确定SMT是否能改善自我报告的疲劳、生活质量、抑郁和 焦虑显著高于LT或WLC，分别通过患者报告的结果进行评估 测量系统(PROIS)疲劳量表、生活质量、享受和满意度问卷 -简表(Q-LES-Q)、抑郁症状快速清单--自我报告(QDS-SR16)，以及 GAD-7。2)收集关于SMT与LT对CRF持续作用6周的初步数据，通过 分别于干预后6周和12周测定MFI和PROMIS疲劳量表评分。这 研究将提供初步数据，证明SMT是缓解慢性肾衰的有效干预措施 一组前列腺癌幸存者认为，这种效应是通过关键的促炎和抗炎细胞因子的变化来调节的， 而且SMT改善了生活质量和情绪症状。