Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)
- Conditions
- CancerNeoplasm
- Registration Number
- NCT06672887
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
Not provided
- Employees with cancer and their employers must participate as a dyad. If one party in the dyad is unable or unwilling to participate, the other party cannot participate either.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Successful return to work (employee with cancer) From enrollment to the end of the 12-month follow-up. 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.
- Secondary Outcome Measures
Name Time Method Current work situation (employee with cancer) From enrollment to the end of the 12-month follow-up. 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) From enrollment to the end of the 12-month follow-up. 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) From enrollment to the end of the 12-month follow-up. 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) From enrollment to the end of the 12-month follow-up. Measured on a self-developed 5-point Likert scale (1 item).
Quality of working life (employee with cancer) From enrollment to the end of the 12-month follow-up. The Quality of Working Life Questionnaire for cancer survivors (QWLQ-CS) will be used to measure the experiences and perceptions at work over the past 4 weeks of employees who have resumed work.
Self-efficacy in providing return to work support (employer) From enrollment to the end of the 12-month follow-up. Measured using an adapted version of the Competence scale of empowerment questionnaire (4 items).
Satisfaction with RTW process (employer) From enrollment to the end of the 12-month follow-up. Measured on a self-developed 5-point Likert scale (1 item).
Trial Locations
- Locations (2)
Arbo Unie
🇳🇱Zeeland, Netherlands
Re-turn
🇳🇱Utrecht, Netherlands