Cancer Care Research Centre, School of Nursing, Midwifery and Health, University of Stirling, Stirling, UK.
Trials. 2011 Mar 30;12:89. doi: 10.1186/1745-6215-12-89.
Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR) services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer.
Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS) Boards for 6 months. Eligible patients are all women who are: (1) aged between 18 and 65 years; (2) in paid employment or self-employed; (3) living or working in Lothian or Tayside, Scotland, UK; (4) diagnosed with an invasive breast cancer tumour; (5) treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B), fatigue (FACIT-Fatigue) and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer.
To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and feasibility of a larger future trial involving patients with breast, prostate or lung cancer and inform the development of appropriate VR services for people living with cancer.
由于癌症存活率的提高，在欧洲，处于工作年龄段且患有癌症的人数可能会增加。英国政府已承诺减少因健康问题而损失的工作日，并改善获得职业康复（VR）服务的机会。使癌症患者重返工作岗位已被确定为优先事项。但是，几乎没有支持人们在癌症后继续或重返工作的服务，也没有相关试验来评估其影响。一项针对乳腺癌女性的试点随机对照试验旨在评估为癌症患者提供 VR 服务的更大确定性试验的可行性。
在苏格兰两个国民保健服务（NHS）委员会的三个临床站点中，正在招募 6 个月的患者。符合条件的患者均为：（1）年龄在 18 至 65 岁之间；（2）有薪就业或自营职业；（3）居住或工作在苏格兰的洛锡安或泰赛德；（4）诊断为浸润性乳腺癌肿瘤；（5）首先接受手术治疗。患者被随机分配接受 VR 服务或常规护理转诊，后者不涉及任何正式的就业支持。主要结局指标是手术后的前 6 个月内自我报告的病假情况。次要结局指标包括基线和手术后 6 个月和 12 个月之间生活质量（FACT-B）、疲劳（FACIT-Fatigue）和就业状况的变化。试验后评估将用于评估参与者对干预措施的可接受性以及针对肺癌和前列腺癌患者进行更大、更确定性试验的可行性。
据我们所知，这是第一项确定 VR 服务有效性的随机对照试验可行性的研究，该试验旨在使癌症患者能够继续或重返工作岗位。该研究将提供证据来评估涉及乳腺癌，前列腺癌或肺癌患者的更大未来试验的相关性和可行性，并为癌症患者提供适当的 VR 服务。
