Institute for Social Medicine and Epidemiology, University of Lübeck; Department of Psychology & Methods, University of Bremen; Paracelsus-Klinik am See, Bad Gandersheim; AMEOS Reha Klinikum, Ratzeburg; MediClin Rose Klinik, Horn-Bad Meinberg; Klinik Bavaria, Freyung.
Dtsch Arztebl Int. 2019 Sep 2;116(35-36):592-599. doi: 10.3238/arztebl.2019.0592.
Current guidelines recommend rehabilitative measures to alleviate dis- turbances resulting from cancer and its treatment. To give cancer survivors further assistance in getting back to work, work-related medical rehabilitation is currently being tested in Germany. In this cluster-randomized, multicenter trial, we studied the efficacy of work-related medical rehabilitation compared with conventional medical rehabilitation (trial no. DRKS00007770 in the German Clinical Trials Registry).
A total of 484 cancer survivors of working age who were candidates for rehabilitation were recruited and assigned at random to either the intervention group (IG; work-related medical rehabilitation) or the control group (CG). The primary end- point was self-assessed function in a role one year after the end of rehabilitation, as evaluated with the health-related quality of life questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30). Further endpoints included symptom and function scales, subjective ability to work, coping with illness, and return to work. Neither the medical personnel nor the subjects were blinded.
One year after the end of rehabilitation, data from 379 subjects who par- ticipated in the last follow-up survey were evaluated. The intervention and control groups did not differ significantly either in the primary endpoint of role function (IG = 60.8 vs. CG = 57.6 out of a maximum of 100 points; p = 0.204) or in any of the secondary endpoints. A last observation carried forward analysis yielded com- parable results. At 12 months, 28.5% of the subjects in the IG and 25.3% of those in the CG were still unable to work.
This study did not reveal any significant clinically relevant advantage of work-related medical rehabilitation at one year. Future studies should determine whether a second period of rehabilitation might be helpful and whether selected subjects might benefit from the assistance of case managers beyond the period of rehabilitation.
目前的指南建议采取康复措施来减轻癌症及其治疗带来的干扰。为了进一步帮助癌症幸存者重返工作岗位,目前正在德国开展与工作相关的医疗康复。在这项集群随机、多中心试验中,我们研究了与常规医疗康复相比,与工作相关的医疗康复的疗效(德国临床试验注册处登记号 DRKS00007770)。
共招募了 484 名符合康复条件的处于工作年龄的癌症幸存者,并将他们随机分配到干预组(IG;与工作相关的医疗康复)或对照组(CG)。主要终点是康复结束后一年时自我评估的角色功能,使用欧洲癌症研究与治疗组织(EORTC)生活质量问卷(QLQ-C30)进行评估。其他终点包括症状和功能量表、主观工作能力、应对疾病和重返工作。医务人员和受试者均未设盲。
在康复结束后一年,对参加最后一次随访调查的 379 名受试者的数据进行了评估。干预组和对照组在角色功能的主要终点(IG = 60.8,CG = 57.6,满分 100 分;p = 0.204)或任何次要终点上均无显著差异。采用最后观察值结转分析得出了可比的结果。在 12 个月时,IG 组有 28.5%的受试者和 CG 组有 25.3%的受试者仍无法工作。
这项研究在一年时没有发现与工作相关的医疗康复有任何显著的临床相关优势。未来的研究应确定第二个康复期是否有帮助,以及是否有选择的受试者在康复期之外可能受益于个案经理的帮助。