Massage to Enhance Quality of Life in ASCT Patients

按摩提高 ASCT 患者的生活质量

• 批准号: 6818281
• 负责人: ANN GILL TAYLOR
• 金额: $ 20.53万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-15 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6818281
• 关键词: adult human (21+); autologous transplantation; behavioral /social science research tag; cancer pain; clinical research; combination cancer therapy; data collection methodology /evaluation; human subject; human therapy evaluation; massage therapy; medical complication; neoplasm /cancer chemotherapy; neoplasm /cancer radiation therapy; outcomes research; pain; patient care management; physiologic stressor; psychological aspect of cancer; psychological stressor; quality of life; questionnaires; stem cell transplantation

DESCRIPTION (provided by applicant) Patients with cancer undergoing autologous stem cell transplantation (ASCT) endure stressors and symptoms throughout treatment, resulting in greatly impaired quality of life (QoL). Despite advances in conventional symptom management, patients often experience significant emotional distress (anxiety, stress, and depressive symptoms), pain, fatigue, nausea, and vomiting prior to and following ASCT. Psychosocial interventions that alleviate stress and induce relaxation can reduce treatment-related symptoms and improve QoL in many patients with cancer. However, some patients are not responsive to these approaches, and more passive therapies may be preferred by patients with impaired concentration and/or fatigue. This revised exploratory application proposes a novel seven-week massage therapy intervention that potentially could reduce symptoms and improve QoL. The study will utilize a prospective, randomized two-group design. Thirty-two patients with cancer (ages >= 18) scheduled to receive ASCT at the University of Virginia Cancer Center will be recruited, evaluated with baseline measures, and randomly assigned to receive either: (1) standard medical care alone (SMC); or (2) SMC plus seven weeks of massage therapy. Patients will complete weekly questionnaires (QoL, symptoms) during the intervention period. The primary aims of the study are to explore: 1) the feasibility of the study design and massage intervention protocol; and 2) the estimation of the changes in QoL and symptoms over time in each group (massage and SMC). The stressors and symptoms of ASCT could potentially reduce cardiac vagal tone, and massage has been demonstrated to stimulate parasympathetic outflow. Thus, the investigators propose a secondary aim to explore the use of power spectral analysis of short-term heart rate variability (HRV) in obtaining preliminary estimates of immediate and/or cumulative changes in parasympathetic tone (high frequency component of HRV) after either massage (treatment group) or rest (SMC group). These analyses will provide the foundation for designing a large multi-site RCT (R01) that will examine the effects and mechanisms of massage therapy for patients with cancer undergoing ASCT

描述（由申请人提供） 接受自体干细胞移植（ASCT）的癌症患者在整个治疗过程中承受压力和症状，导致生活质量（QoL）严重受损。尽管在常规症状管理方面取得了进展，但患者在ASCT之前和之后通常会经历显著的情绪困扰（焦虑，压力和抑郁症状），疼痛，疲劳，恶心和呕吐。缓解压力和诱导放松的心理社会干预可以减少许多癌症患者的治疗相关症状并改善QoL。然而，有些患者对这些方法没有反应，注意力受损和/或疲劳的患者可能更喜欢被动治疗。这项修订后的探索性申请提出了一种新的7周按摩治疗干预，可能会减轻症状并改善生活质量。本研究将采用前瞻性、随机化两组设计。将招募32名计划在弗吉尼亚大学癌症中心接受ASCT的癌症患者（年龄≥ 18岁），使用基线测量进行评估，并随机分配接受：（1）单独的标准医疗护理（SMC）;或（2）SMC加7周按摩治疗。患者将在干预期间完成每周一次的问卷调查（QoL、症状）。本研究的主要目的是探索：1）研究设计和按摩干预方案的可行性; 2）估计各组（按摩和SMC）的QoL和症状随时间的变化。ASCT的应激源和症状可能会降低心脏迷走神经张力，按摩已被证明可以刺激副交感神经流出。因此，研究人员提出了一个次要目的，探索使用短期心率变异性（HRV）的功率谱分析，以获得按摩（治疗组）或休息（SMC组）后副交感神经张力（HRV的高频成分）的即时和/或累积变化的初步估计。这些分析将为设计一项大型多中心RCT（R 01）提供基础，该RCT将检查按摩疗法对接受ASCT的癌症患者的作用和机制