Abstract
BackgroundEmployers express a need for support to facilitate the return to work (RTW) process of employees with cancer. We have developed the MiLES intervention, an online toolbox targeting employers during the RTW of employees with cancer. To evaluate the MiLES intervention, we propose the design of a pilot randomised controlled trial (RCT). The aim of this pilot is to determine whether a future RCT to study the effectiveness of this intervention on successful RTW of employees with cancer is feasible. Secondary aims are to obtain preliminary results on the effectiveness of the intervention and to determine the sample size needed in a future definitive RCT.MethodsA pilot RCT with a 6-month follow-up will be conducted. Using medical specialists at Dutch hospitals, we aim to enrol 90 participants diagnosed with cancer (<2 years earlier) aged 18–63 years who are in paid employment with an employer and who are currently sick-listed or partly sick-listed for <1 year. Participants randomised to the intervention group will be asked to inform their employer about the online toolbox supporting employers during the RTW process of employees with cancer. Participants in the control group will receive ‘care as usual’ from their employer. All measures will be assessed at the level of the employee using questionnaires at baseline and after 3 and 6 months of follow-up. The feasibility of a future RCT will be determined using criteria concerning method-related uncertainties and acceptability of the study protocol. The primary effect measure will be successful RTW (that is, RTW perceived as being successful by the cancer survivor themselves). This effect measure will be used to perform the sample size calculation for a future definitive RCT.DiscussionThe design is proposed to determine the feasibility to study the effectiveness of the MiLES intervention targeting employers on the successful RTW of employees diagnosed with cancer. This pilot RCT can increase the probability of a successful future definitive RCT on the effectiveness of the intervention and potentially obviate the need to carry out an unfeasible and resource-intensive study.Trial registrationDutch Trial Register (NTR): NL6758, NTR7627. Registered on 30 October 2018.
Highlights
Employers express a need for support to facilitate the return to work (RTW) process of employees with cancer
Secondary objectives are to obtain preliminary results on the effectiveness of the intervention on successful RTW and to determine the sample size needed in a future definitive randomised controlled trial (RCT) to study the effectiveness of the intervention
The study will include employees diagnosed with cancer and will compare the The missing link (MiLES) intervention targeting the employer of included employees with a waiting-list control group in which the employer will not receive the intervention
Summary
Employers express a need for support to facilitate the return to work (RTW) process of employees with cancer. To evaluate the MiLES intervention, we propose the design of a pilot randomised controlled trial (RCT) The aim of this pilot is to determine whether a future RCT to study the effectiveness of this intervention on successful RTW of employees with cancer is feasible. Being unable to work is unfortunate for cancer survivors as work provides social interaction and financial security and is associated with a higher quality of life [9, 10]. At both the organisational and the societal level, improving the work participation of cancer survivors might reduce the economic burden of a cancer diagnosis [11]. Increasing the work participation of cancer survivors is a relevant topic both for the individual and for organisations and society at large [9,10,11]
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