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.

今天在美国拥有超过1550万的癌症存活，对质量的关注正在增加 癌症治疗后的生活。与癌症相关的疲劳（CRF），一种持久的，主题的身体感， 与癌症或其治疗相关的情绪和/或认知疲惫，与最近 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 癌症治疗完成后可以持续数月或数年。前列腺癌（PCA）是最普遍的 男性癌症，对影响老年男性的任何癌症的医疗保险支出最高。现代量身定制 治疗方案导致预期寿命更长，这导致了与治疗相关的发病率和 不良副作用，包括心理困扰，疼痛和CRF。此R21将研究治疗 瑞典按摩疗法（SMT）对PCA中CRF的生物学作用，是我们的扩展 CRF完成了乳腺癌存活的研究，表明SMT在临床上产生 疲劳和生活质量的统计学显着改善（QOL）。同质的PCA幸存者 CRF（每组n = 15）将被随机分为三个条件之一：每周一次的SMT 6周，6 每周一次的轻度触摸（LT）或6周的等待列表控制（WLC）条件。完成的主题 在上次研究访问后6和12周时，将跟踪SMT或LT的CRF持续变化。我们 假设SMT将在改善PCA的疲劳，情绪和QOL方面具有临床意义的好处 患者，这将与可能是CRF基础的物理参数的有利变化有关 并可能影响疾病进展。主要目的：进行初步研究以确定 接受两种辐射的PCA冲浪器中的6周SMT干预是否会降低CRF 和雄激素剥夺疗法。次要目的：确定假设的CRF减少 SMT与调节慢性炎症基础的特定免疫系统因素有关。 探索目的：1）确定SMT是否改善了自我报告的疲劳，QOL，抑郁症和 焦虑明显超过LT或WLC，如患者报告的结果分别评估 测量系统（Promis）疲劳量表，生活质量，享受和满意问卷 - 简短形式（Q-LES-Q），抑郁症状的快速清单 - 自我报告（QIDS-SR16）和 GAD-7。 2）收集有关6周SMT与LT在CRF上的持续行动的初步数据， 干预后6周零12周，测量MFI和Promis疲劳量表得分。这 研究将提供初步数据，表明SMT是缓解CRF的有效干预措施 一组PCA表面，这种效应是由关键促促促疾病和抗炎细胞因子的变化介导的 SMT改善了质量和情绪症状。