Effectiveness, cost-effectiveness, and return on investment of the web-based MiLES intervention targeted at employers, to enhance successful return to work of employees with cancer: design of a randomized controlled trial.
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BACKGROUND: The MiLES intervention is a digital employer-based tool aimed at enhancing return to work (RTW) of employees with cancer through interactive videos, conversation checklists and tips and information. In a previous study, the MiLES intervention proved to be a useful intervention that aligns with employers' daily practice. The hypothesis is that the MiLES intervention will enhance the employers' willingness, ability and self-efficacy in providing RTW support, which in turn will enhance the RTW of employees with cancer. This paper describes the design of a randomized controlled trial (RCT), aimed at evaluating the effectiveness, cost-effectiveness and return on investment of the MiLES intervention. Parallel to the RCT, a process evaluation of the delivery of the MiLES intervention in a real-world setting will be conducted. METHODS: An RCT with a 12-month follow-up period will be conducted involving 140 employer-employee dyads. The employees are diagnosed with cancer (< 2 years earlier), aged 18-67 years, in paid employment with an employer, and currently fully or partly sick-listed (< 2 years). The employer provides RTW support to the included employee. All dyads will either be allocated to the intervention group, of which the employer will get access to the MiLES intervention, or to the control group in which care as usual will be provided. The primary outcome will be successful RTW (encompassing the employee's perspectives on RTW) at the level of the employee; secondary outcomes will include the following: time to RTW, quality of life and quality of working life, received work-related support, and satisfaction with work-related support. At the level of the employer, the secondary outcomes will include the following: self-efficacy in providing RTW support and satisfaction with the RTW process. All outcomes will be assessed using questionnaires at baseline and at 3, 6 and 12 months of follow-up. Both the cost-effectiveness and the return on investment analysis will be conducted from the employers perspective. For the process evaluation, the UK MRC framework will be used. DISCUSSION: This RCT will study the effectiveness, cost-effectiveness and return on investment of the MiLES intervention. This knowledge is needed to formulate recommendations regarding the implementation of the MiLES intervention beyond the research setting. TRIAL REGISTRATION: ClinicalTrials.gov, NCT06672887. Registered on October 25, 2024.