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.

如今美国有超过 1550 万癌症幸存者，人们越来越关注质量 癌症治疗后的生活的疲劳（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/或认知疲惫与最近的情况不成比例 活动，是癌症患者中最常见、最具破坏性的症状之一。 癌症治疗完成后可能会持续数月或数年 前列腺癌 (PCa) 是最常见的。 男性癌症，并且是影响老年男性的所有癌症中医疗保险支出最高的现代定制。 治疗方案导致预期寿命延长，从而导致治疗相关的发病率和 不良副作用，包括心理困扰、疼痛和 CRF，本 R21 将研究治疗方法。 瑞典按摩疗法 (SMT) 对 PCa 中 CRF 的生物效应，是我们的延伸 完成了针对具有 CRF 的乳腺癌幸存者的研究，证明 SMT 可以产生临床和 疲劳和生活质量 (QOL) 方面有统计学显着改善 一组同质的 PCa 幸存者。 患有 CRF（每组 n=15）的患者将被随机分配到以下三种情况之一：每周一次的 SMT 6 周，6 每周一次的 Light Touch (LT) 或 6 周的等待名单控制 (WLC) 条件完成的受试者。 我们将在最后一次研究访视后 6 周和 12 周对 SMT 或 LT 进行随访，以了解 CRF 的持续变化。 SMT 将在改善 PCa 患者的疲劳、情绪和生活质量方面具有临床意义的益处 患者，并且这将与可能构成 CRF 的生理参数的有利变化相关 并可能影响疾病进展 主要目标：进行初步研究以确定。 为期 6 周的 SMT 干预是否会降低接受两种放疗的 PCa 幸存者的 CRF 次要目标：确定 CRF 是否明显降低。 SMT 与慢性炎症背后的特定免疫系统因素的调节有关。 探索性目标：1) 确定 SMT 是否可以改善自我报告的疲劳、生活质量、抑郁和 根据患者报告的结果（分别）评估，焦虑程度明显高于 LT 或 WLC 测量系统 (PROMIS) 疲劳量表、生活质量、享受和满意度问卷 – 简表 (Q-LES-Q)、抑郁症状快速清单 – 自我报告 (QIDS-SR16) 以及 GAD-7) 收集关于 6 周 SMT 与 LT 对 CRF 的持续作用的初步数据，方法是： 在干预后 6 周和 12 周测量 MFI 和 PROMIS 疲劳量表评分。 研究将提供初步数据，证明 SMT 是减轻 CRF 的有效干预措施 一组前列腺癌幸存者，这种效应是由关键促炎和抗炎细胞因子的变化介导的， SMT 可以改善生活质量和情绪症状。