“癌症患者重返工作岗位”项目——一项由护士主导、分阶段护理的电子健康干预措施，旨在提高癌症患者的重返工作率：一项随机对照试验的研究方案
Cancer@Work - a nurse-led, stepped-care, e-health intervention to enhance the return to work of patients with cancer: study protocol for a randomized controlled trial.
作者信息
Tamminga Sietske J, Hoving Jan L, Frings-Dresen Monique H W, de Boer Angela G E M
机构信息
Coronel Institute of Occupational Health, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
出版信息
Trials. 2016 Sep 15;17(1):453. doi: 10.1186/s13063-016-1578-8.
BACKGROUND
Although the importance of work for patients with cancer is nowadays more acknowledged both in the literature as well as in cancer survivorship care, effective interventions targeting the return to work of these patients are still scarce. Therefore, we developed a nurse-led, stepped-care, e-health intervention aimed at enhancing the return to work of patients with cancer. The objective of this study is to describe the content of the intervention and the study design used to evaluate the feasibility and (cost) effectiveness of the intervention.
METHODS
We designed a multi-centre randomised controlled trial with a follow-up of 12 months. Patients who have paid employment at the time of diagnosis, are on sick leave and are between 18-62 years old will be eligible to participate. After patients have signed the informed consent form and filled in the baseline questionnaire, they are randomly allocated to either the nurse-led, stepped-care, e-health intervention called Cancer@Work, or care as usual. The primary outcome is sustainable return to work. Secondary outcomes are sick leave days, work ability, work functioning, quality of life, quality of working life and time from initial sick leave to full return to work without extensive need for recovery. The feasibility of the Cancer@Work intervention and direct and indirect costs will be determined. Outcomes will be assessed by questionnaires at 3, 6, 9 and 12 months of follow-up.
DISCUSSION
The results of this study will provide new insights into the feasibility and (cost) effectiveness of Cancer@Work, a nurse-led, stepped-care, e-health intervention for cancer patients aimed at enhancing their return to work. If proven effective, the intention is to implement the Cancer@Work intervention in usual psycho-oncological care.
TRIAL REGISTRATION
NTR (Netherlands Trial Registry): NTR5190 . Registered on 18 June 2015.
背景
尽管如今在文献以及癌症幸存者护理中，工作对癌症患者的重要性得到了更多认可，但针对这些患者重返工作岗位的有效干预措施仍然匮乏。因此，我们开发了一种由护士主导、分阶段进行的电子健康干预措施，旨在促进癌症患者重返工作岗位。本研究的目的是描述该干预措施的内容以及用于评估其可行性和（成本）效益的研究设计。
方法
我们设计了一项为期12个月随访的多中心随机对照试验。在诊断时已就业、正在休病假且年龄在18至62岁之间的患者将有资格参与。患者签署知情同意书并填写基线问卷后，将被随机分配到名为“癌症与工作”（Cancer@Work）的由护士主导、分阶段进行的电子健康干预组或常规护理组。主要结局是可持续重返工作岗位。次要结局包括病假天数、工作能力、工作功能、生活质量、工作生活质量以及从开始休病假到无需大量恢复即可完全重返工作岗位的时间。将确定“癌症与工作”干预措施的可行性以及直接和间接成本。在随访的3、6、9和12个月时通过问卷评估结局。
讨论
本研究结果将为“癌症与工作”这一由护士主导、分阶段进行的电子健康干预措施（旨在促进癌症患者重返工作岗位）的可行性和（成本）效益提供新的见解。如果证明有效，计划在常规心理肿瘤护理中实施“癌症与工作”干预措施。
试验注册
荷兰试验注册库（NTR）：NTR5190。于2015年6月18日注册。
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