Effects & Costs of Massage in Hospice Cancer Patients

描述(由申请人提供)：超过80%的临终关怀患者在生命的最后几天会经历痛苦的症状，这些症状会严重影响舒适度。之前的研究表明，按摩等免费疗法可以在几分钟到几个小时内缓解症状，但还没有人研究过按摩疗法的累积效果或为临终关怀患者提供按摩的经济有效的方法。我们提出了一项随机临床试验(RCT)，在200名癌症临终关怀患者的不同群体中，比较常规护理和常规护理加上持证按摩治疗师(LMT)每天5次按摩治疗对症状的影响，包括：a)症状苦恼、b)疼痛、c)情绪状态和d)睡眠质量。在试验前/试验后的设计中，患者将完成计算机化的评估，在重复测量之前有5天的磨合期。所有患者将接受常规家庭护理水平的临终关怀，随机分为试验组，每天接受为期1周的推拿治疗。从第2天到第6天，每个变量的结果分数将被汇总，并使用Manova进行分析，如果获得显著的小组结果，则进行事后比较。研究结果将被用来指导临终关怀提供者选择循证的免费干预措施，以缓解人们在生命末期的痛苦症状。第二个目标是确定按摩干预的成本，并比较普通临终关怀和普通临终关怀加按摩对临终关怀报销和使用成本的影响。我们将使用基于活动的两步成本计算方法来确定干预的成本及其对成本结果的影响。我们假设临终关怀补偿和使用成本不会有差异，这意味着干预将是成本中性的。第三个探索性目标是描述LMT的可行性和照顾者压力，培训60名家庭照顾者，让他们在家中为60名完成目标1程序的临终关怀患者提供日常按摩。可行性将通过以下几个方面进行评估：a)护理者按摩熟练程度；b)护理者提供的按摩频率和时长；c)护理者和患者关于按摩体验的自我报告。压力定义为照顾者压力在1周内的变化。我们希望家庭照顾者将在2次培训、评估和LMT反馈后接受培训，以提供熟练的按摩。我们还预计照顾者将每天进行3次按摩，每次20至30分钟，并且报告称他们的照顾者压力没有显著增加。将使用Atlas.ti的描述性统计和内容分析来评估家庭照顾者提供按摩的可行性，并设计一项临床效果研究，将家庭成员作为LMT的成本效益替代方案。

DESCRIPTION (provided by applicant): More than 80% of hospice patients experience distressing symptoms that significantly impact comfort in their final days of life. Previous research demonstrated that complimentary therapies such as massage can alleviate symptoms for minutes to hours, but none have examined cumulative effects of massage therapy or cost-effective methods of providing massage to hospice patients. We propose a randomized clinical trial (RCT) comparing usual care versus usual care plus 5 daily massage therapy sessions given by licensed massage therapists (LMT) on symptom outcomes including: a) symptom distress, b) pain, c) mood state and d) sleep quality in a diverse group of 200 hospice patients with cancer. In a pre-test/post-test design with repeated measures preceded by a 5-day run-in period, patients will complete computerized assessments. All patients will receive usual home care level of hospice care, and patients randomized to the experimental group will receive daily massage therapy for 1 week. Outcome scores will be aggregated for each variable from day 2 to day 6 and analyzed using MANOVA, with post-hoc comparisons if significant group results are obtained. Study findings will be used to guide hospice care providers in selecting evidence-based complimentary interventions to relieve distressing symptoms in people at the end of life. A second aim is to determine the costs of the massage intervention and compare the effects of usual hospice care and usual care plus massage on hospice reimbursement and utilization costs. We will use a 2-step activity-based costing methodology for determining the costs of the intervention and the effects on cost outcomes. We hypothesize that the hospice reimbursements and utilization costs will not differ, meaning that the intervention will be cost neutral. A third exploratory aim is to describe the feasibility and the caregiver strain of LMT training 60 family caregivers to give daily massages at home to 60 of the hospice patients who completed Aim 1 procedures. Feasibility will be evaluated by: a) caregiver massage proficiency; b) massage frequency and length given by caregivers; c) caregiver and patient self-report about the massage experience. Strain is defined as the 1-week change in caregiver strain. We expect that family caregivers will be trained to give massages at a proficient level after 2 sessions with training, evaluation and feedback from a LMT. We also expect that caregivers will give 3 daily massages, each for 20 to 30 minutes and report no significant increase in their caregiver strain. Descriptive statistics and content analysis with Atlas.ti will be used to evaluate the feasibility of family caregivers providing massages and to design a clinical effectiveness study using family members as a cost-effective alternative to LMTs.