NCT06672887

Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The investigators will include 140 employer-employees with cancer dyads. The employees are diagnosed with cancer (\<2 years earlier), aged 18-65 years, in paid employment with an employer, and currently fully or partly sick-listed (\<2 years). The employer supports and guides the participating employee with cancer during the period of sick leave and RTW (e.g. as the direct supervisor or HR-manager). Employers of dyads randomized to the intervention group will get unlimited access to the web-based MiLES intervention, aimed at enhancing the successful RTW of employees with cancer, by supporting employers. This intervention includes among others interactive video's, conversation checklists, and tips and information. Employers of dyads randomized to the control group will not get access to the MiLES intervention, thus dyads will get care as usual. The primary outcome will be successful RTW, measured at the level of the employee. Secondary outcomes will include: current work situation (including 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: 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.

Conditions

• Cancer
• Neoplasm

Interventions

Type	Name	Description
OTHER	MiLES	The 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.

Timeline

• Start date: 2023-12-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-11-04
• Last updated: 2024-11-04

Locations

5 sites across 1 country: Netherlands