The objective of this randomized controlled trial (RCT) is to evaluate the effectiveness of the MiLES intervention targeted at employers, on successful return to work (RTW) of employees with cancer, compared to care as usual (CAU).
Secundary objectives are:
* To evaluate the cost-effectiveness and return-on-investment of the MiLES intervention on successful RTW and quality of life, compared to CAU. * To evaluate the effectiveness of the MiLES intervention on several outcome measures on the level of the employee with cancer (time to RTW, quality of life, quality of working life, received work-related support, and satisfaction with work-related support), and the level of the employer (self-efficacy in providing RTW support, and satisfaction with the RTW process).
Participants will be 140 employer-employee with cancer dyads. All dyads will randomly be allocated to the intervention group, of which the employer will get unlimited access to the MiLES intervention, or to the control group in which CAU will be provided. The follow-up of this study will be 12 months.
Along with the RCT, a process evaluation using the UK Medical Research Council framework will also be conducted.
Diagnosed with cancer <2 years earlier;
Being of working age (between 18-65 years, considering the Dutch retirement age of 67 years, and the study's follow-up period of one year);
In paid employment with an employer;
Having either an occupational physician at the involved occupational health service or a reintegration consultant at the involved reintegration service (e.g. working for an organization that is affiliated with one of the settings of this study);
None
Parallel
MiLES
Other interventionThe MiLES intervention is an open access website, accessible via an URL, but not traceable through any online search engine during the study period. Tailored for specific preferences and needs of different employees with cancer, the MiLES intervention consists of interactive videos, conversation checklists, tips and information regarding RTW guidance of employees with cancer, and an overview of involved stakeholders and relevant legislation. The MiLES intervention intends to optimize the RTW support the employer provides to the employee with cancer by enhancing the willingness and ability to implement the employer actions. The MiLES intervention focuses for example on fostering effective communication between the employer and employee, while disregarding assumptions based on previous experiences.
Successful return to work (employee with cancer)
The primary effect measure "successful RTW" is a combination of two components: 1. Actual RTW: All employees will be asked about performed work activities in the past 4 weeks \[yes/no\]. This can be either their regular work activities or (temporarily) modified work activities. 2. Successful RTW (14-items): Employees who have resumed work (actual RTW is answered by "yes") will also be asked about the extent to which they perceive their RTW as "successful", using the I-RTW\_CS questionnaire. The I-RTW\_CS is specifically developed as an RTW outcome measure that represents the perspectives of employees with cancer, with items that could be influenced by an employer.
Current work situation (employee with cancer)
Employees who have resumed work will be asked about their current work situation and since when they have returned to work (fully or partially). The questionnaire is self-developed and includes 9 items (e.g. time to RTW).
Quality of life (employee with cancer)
The SF-12 questionnaire will be used to measure the perceived impact of health on a participant's everyday life (12 items).
Received work-related support from the employer (employee with cancer)
Measured using self-developed questions, including the frequency of contact and its average duration (4-items).
Satisfaction with work-related support from their employer (employee with cancer)
Measured on a self-developed 5-point Likert scale (1 item).
Cost-effectiveness and return on investment
The cost-effectiveness analysis and the return on investment analysis will be conducted from the employer\'s perspective, comparing the MiLES intervention with care as usual. They will be conducted for the primary outcome measure (i.e. successful RTW) and quality-adjusted life years (QALYs).
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Amsterdam UMC, location AMC
Sponsor institution
Dutch Cancer Society
Collaborator
Re-turn
Collaborator
Arbo Unie
Collaborator
