Cancer Care Research Centre, School of Nursing, Midwifery and Health, University of Stirling, Highland Campus, Centre for Health Science, Old Perth Road, Inverness IV2 3JH, UK.
Trials. 2013 Jun 14;14:175. doi: 10.1186/1745-6215-14-175.
There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study.
Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue.
Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval -15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable.
Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans.
ISRCTN29666484.
在方法学上稳健的职业康复（VR）干预试验相对较少。本研究评估了对乳腺癌女性进行 VR 试验的可行性和可接受性，以为更大规模的干预性研究提供信息。
在苏格兰招募女性患者，将其随机分配至个案管理 VR 服务或常规护理组。收集入组率、招募率和失访率以评估试验可行性，并通过访谈确定试验可接受性。通过邮寄问卷在术后前 6 个月每 4 周和 12 个月时自我报告病假天数（主要结局）。次要结局指标为就业模式变化、生活质量和疲劳。
在评估的 1114 名符合条件的女性中，163 名（15%）符合条件。不纳入的主要原因是年龄（>65 岁，n=637，67%）。在符合条件的患者中，111 名（68%）收到了研究信息，其中 23 名（21%）同意参加研究。分析了 18 名（78%）女性的数据（干预组：n=7；对照组：n=11）。与对照组相比，干预组患者在术后前 6 个月的病假天数平均减少了 53 天，但差异无统计学意义（p=0.122；95%置信区间-15.8，122.0）。次要结局未发现统计学差异。对试验参与者的访谈表明，试验程序（包括招募、随机化和研究工具）是可接受的。
对癌症幸存者的 VR 干预有效性进行实用试验是可行且可接受的，但需要进一步研究 VR 干预的确切内容和用于衡量有效性的结局。VR 协助乳腺癌患者重返工作岗位是癌症生存计划的重要组成部分。
ISRCTN29666484。
