BACKGROUND Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment. METHOD A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients' symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants' health-related quality of life, their satisfaction with the intervention, and an economic valuation. DISCUSSION This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system. TRIAL REGISTRATION The COMTHECARE study is registered at Clinical Trials.gov, NCT04052074. Registered 9 August, 2019.

中文翻译：

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在家中姑息治疗及其照护者中针对癌症患者的补充音乐疗法：一项多中心随机对照试验的方案。

背景技术患有晚期癌症的患者，在家里接受姑息治疗，会遭受许多可改变的症状，并且常常需要引起关注，这种压力很大的情况也会影响家庭护理人员。已经提出，音乐疗法可以使患者和护理人员都受益。我们提出一项研究，以分析音乐干预计划作为补充疗法对姑息治疗中的癌症患者及其家庭护理人员（与常规治疗相比）的功效和成本效用。方法将对在家中姑息治疗的癌症患者及其家属进行一项随机，双盲，多中心的临床试验。研究人群将包括40名患者的两个样本和41个护理者的两个样本。参与者将被随机分配到干预组或对照组。干预小组将接受为期7天的课程，其中包括音乐课，而对照组则接受7次（口语）治疗教育。在这项研究中，主要结局指标是根据埃德蒙顿症状评估系统评估患者的症状，并通过护理者应变指数来衡量家庭护理者所承受的超负荷。考虑的次要结果是参与者的健康相关生活质量，他们对干预的满意度以及经济价值。讨论这项研究有望增进我们对姑息治疗中的癌症患者及其家人的音乐疗法的功效和成本效用的理解。预期该项目的结果将适用于家庭姑息治疗患者及其护理人员，并可应用于常规临床实践。可以将所描述的方法作为综合性姑息治疗中的其他治疗资源。据我们所知，以前没有进行过基于双盲临床试验的高质量研究来评估音乐疗法的成本效益。该项目的成本效益将提供信息以支持决策，从而改善对卫生资源的管理及其在卫生系统中的使用。试验注册COMTHECARE研究在Clinical Trials.gov（NCT04052074）上进行了注册。注册于2019年8月9日。