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Effectiveness of work-related medical rehabilitation in cancer patients: study protocol of a cluster-randomized multicenter trial

机译:与工作相关的医疗康复在癌症患者中的有效性:一项集群随机多中心试验的研究方案

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Background Work is a central resource for cancer survivors as it not only provides income but also impacts health and quality of life. Additionally, work helps survivors to cope with the perceived critical life event. The German Pension Insurance provides medical rehabilitation for working-age patients with chronic diseases to improve and restore their work ability, and support returning to or staying at work, and thus tries to sustainably avoid health-related early retirement. Past research showed that conventional medical rehabilitation programs do not support returning to work sufficiently and that work-related medical rehabilitation programs report higher return-to-work rates across several health conditions, when compared to medical rehabilitation. Therefore, the current study protocol outlines an effectiveness study of such a program for cancer survivors. Methods To evaluate the effectiveness of work-related medical rehabilitation in cancer patients we conduct a cluster-randomized multicenter trial. In total, 504 rehabilitation patients between 18 and 60?years with a Karnofsky Performance Status of ≥70?%, a preliminary positive social-medical prognosis of employability for at least 3?h/day within the next 6?months and an elevated risk of not returning to work will be recruited in four inpatient rehabilitation centers. Patients are randomized to the work-related medical rehabilitation program or the conventional medical rehabilitation program based on their week of arrival at each rehabilitation center. The work-related medical rehabilitation program comprises additional work-related diagnostics, multi-professional team meetings, an introductory session as well as work-related functional capacity training, work-related psychological groups, and social counseling. All additional components are aimed at the adjustment of the patients’ capacity in relation to their individual job demands. Role functioning defines the main study outcome and will be assessed with the EORTC-QLQ30. Secondary outcome measures are the remaining scales of the EORTC-QLQ30, fatigue, self-rated work ability, disease coping, participation in working life, realization of work-related goals and therapies during rehabilitation, and treatment satisfaction. Discussion A positive evaluation of work-related medical rehabilitation in cancer patients is expected due to the promising findings on the effectiveness of such programs for patients with other health conditions. Results may support the dissemination of work-related medical rehabilitation programs in German cancer rehabilitation. Trial registration German Clinical Trials Register DRKS00007770 . Registered 13 May 2015.
机译:背景工作是癌症幸存者的主要资源,因为它不仅提供收入,而且影响健康和生活质量。此外,工作还可以帮助幸存者应对重要的生命事件。德国养老保险为患有慢性疾病的适龄患者提供医疗康复,以改善和恢复他们的工作能力,并支持重返工作岗位或继续工作,从而力求可持续地避免因健康而提前退休。过去的研究表明,传统的医学康复计划无法充分支持重返工作岗位,与工作相关的医学康复计划报告,与医学康复相比,在多种健康状况下返工率更高。因此,当前的研究方案概述了针对癌症幸存者的此类程序的有效性研究。方法为了评估癌症患者工作相关医疗康复的有效性,我们进行了一项集群随机多中心试验。总共504名18至60岁之间的康复患者,其Karnofsky绩效状态≥70%,在接下来的6个月内每天至少有3小时/天的初步社会医学预后阳性结果,且风险较高不工作的人将在四个住院康复中心招募。根据患者到达每个康复中心的一周,将他们随机分为与工作有关的医疗康复计划或常规医疗康复计划。与工作有关的医疗康复计划包括其他与工作有关的诊断,多专业团队会议,入门课程以及与工作有关的功能能力培训,与工作有关的心理团体和社会咨询。所有其他组成部分旨在根据患者的个人工作需求来调整他们的能力。角色功能定义了主要的研究结果,并将通过EORTC-QLQ30进行评估。次要结果指标是EORTC-QLQ30的其余量表,疲劳,自我评估的工作能力,疾病应对能力,参与工作生活,康复期间实现与工作有关的目标和疗法以及治疗满意度。讨论由于对此类计划对其他健康状况患者的有效性具有可喜的发现,因此有望对癌症患者的工作相关的医疗康复进行积极的评估。结果可能支持在德国癌症康复中传播与工作相关的医学康复计划。试验注册德国临床试验注册DRKS00007770。 2015年5月13日注册。

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