Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, 3-7-30, Habikino, Habikino-city, Osaka, 583-8555, Japan.
Department of Clinical Research, NPO JORTC, Tokyo, Japan.
BMC Palliat Care. 2020 Oct 22;19(1):164. doi: 10.1186/s12904-020-00670-6.
Although rehabilitation is recommended for terminal cancer patients, the specific components and methods of such programs are poorly documented. No studies to date have examined the effectiveness of rehabilitation for terminal cancer patients. This study aims to evaluate the efficacy of a new intervention for rehabilitation therapists, using the Op-reha Guide (Guide to Optimal and Patient-Centred Rehabilitation Practice for Patients in Palliative Care Units [PCUs]) in rehabilitation practice. This guide consists of recommended actions and attitudes for rehabilitation therapists and aims to optimise therapists' actions according to the patient's needs and condition. It shares goals with terminal cancer patients to maintain their activities of daily living (ADL).
This study uses a multicentre, prospective, randomised controlled trial (RCT) design with two parallel groups in PCUs where specialised rehabilitation will be routinely performed for terminal cancer patients by rehabilitation therapists. Participants will be randomised (1:1) to intervention (the Op-reha Guide) and control groups (usual rehabilitation). We will then conduct an observational study in PCUs that do not perform specialised rehabilitation for terminal cancer patients; this will be considered the usual care group, and the efficacy of usual rehabilitation will be quantitatively evaluated. Inclusion criteria are hospitalisation in PCU, European Cooperative Oncology Group Performance Status of 2 or 3, and clinical estimation of life expectancy of 3 weeks or more. Patients with severe symptom burden will be excluded. We hypothesise that the Op-reha Guide will be more effective in maintaining the ADL of terminal cancer patients hospitalised in PCUs than usual rehabilitation. The primary endpoint is defined as the change in (total) modified Barthel Index from baseline to Day 22. Quality of life will be a secondary endpoint. In total, 135 patients will be recruited from 16 Japanese sites between July 2019 and December 2021.
This will be the first trial to evaluate the efficacy of specialised rehabilitation for terminal cancer patients hospitalised in PCUs, and will contribute to the evidence on the efficacy of implementing rehabilitation for terminal cancer patients.
UMIN-CTR, UMIN000037298 R000042525 (date of registration 7 July 2019).
尽管康复治疗被推荐用于晚期癌症患者，但这类方案的具体组成部分和方法记录不佳。迄今为止，尚无研究评估康复治疗对晚期癌症患者的疗效。本研究旨在评估一种新的康复治疗师干预措施的疗效，即使用 Op-reha Guide（姑息治疗病房中患者最佳和以患者为中心的康复实践指南）进行康复实践。该指南包含了康复治疗师的推荐行动和态度，旨在根据患者的需求和病情优化治疗师的行动。它与晚期癌症患者的目标一致，即维持其日常生活活动（ADL）。
本研究采用多中心、前瞻性、随机对照试验（RCT）设计，在常规为晚期癌症患者提供专业康复治疗的姑息治疗病房中设立两个平行组。参与者将按照 1:1 的比例随机分配到干预组（Op-reha Guide）和对照组（常规康复）。然后，我们将在不常规为晚期癌症患者提供专业康复治疗的姑息治疗病房中进行观察性研究，将其视为常规护理组，定量评估常规康复的疗效。纳入标准为：在姑息治疗病房住院、欧洲癌症研究与治疗组织（ECOG）体力状况评分为 2 或 3 分、临床估计预期寿命为 3 周或以上。有严重症状负担的患者将被排除。我们假设 Op-reha Guide 能更有效地维持姑息治疗病房中晚期癌症患者的日常生活活动能力，优于常规康复。主要终点定义为从基线到第 22 天（总）改良巴氏指数的变化。生活质量将作为次要终点。本研究预计将从 2019 年 7 月至 2021 年 12 月，在日本的 16 个地点招募 135 名患者。
这将是第一项评估姑息治疗病房中晚期癌症患者专业康复治疗疗效的试验，将为实施晚期癌症患者康复治疗的疗效证据做出贡献。
UMIN-CTR，UMIN000037298 R000042525（注册日期：2019 年 7 月 7 日）。
