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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
| Re-turn | UNKNOWN |
| Arbo Unie | UNKNOWN |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Employers randomized to the intervention group will get a personal link to the MiLES intervention. |
|
| Control group | No Intervention | The employees randomized to the control group will receive "care as usual" from their employer, as well as from their reintegration consultant or occupational physician. Their employer will not have access to the MiLES intervention during the study period. However, they will gain access for 6 months following a waiting-list period of 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiLES | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful return to work (employee with cancer) | The primary effect measure "successful RTW" is a combination of two components:
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. | From enrollment to the end of the 12-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of the 12-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of the 12-month follow-up. |
Inclusion criteria employees with cancer:
Inclusion criteria employers:
Exclusion Criteria:
- 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judith Mollet, MSc | Contact | +31205669111 | milesonderzoek@amsterdamumc.nl | |
| Michiel Greidanus, PhD | Contact | +31205669111 | m.a.greidanus@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sietske Tamminga, PhD | Amsterdam UMC, location AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arbo Unie | Recruiting | Arnhem | Netherlands | |||
| Arbo Unie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41102780 | Derived | Mollet JM, Greidanus MA, Boot CRL, Vis C, van Dongen JM, de Boer AGEM, Tamminga SJ. 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. Trials. 2025 Oct 16;26(1):417. doi: 10.1186/s13063-025-09092-2. |
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A non-blinded RCT. The investigators will include employer-employee with cancer dyads, and will compare an intervention group, in which the employer will get access to the MiLES intervention, with a control group, in which both the employee and employer will receive care as usual.
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Participants will not be blinded, as it was hard to devise a placebo intervention, and the standard care (no access to the MiLES intervention) was obviously different from the intervention (access to the MiLES intervention).
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| 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). |
| From enrollment to the end of the 12-month follow-up. |
| 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). | From enrollment to the end of the 12-month follow-up. |
| Satisfaction with work-related support from their employer (employee with cancer) | Measured on a self-developed 5-point Likert scale (1 item). | From enrollment to the end of the 12-month follow-up. |
| Quality of working life (employee with cancer) | 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. | From enrollment to the end of the 12-month follow-up. |
| Self-efficacy in providing return to work support (employer) | Measured using an adapted version of the Competence scale of empowerment questionnaire (4 items). | From enrollment to the end of the 12-month follow-up. |
| Satisfaction with RTW process (employer) | Measured on a self-developed 5-point Likert scale (1 item). | From enrollment to the end of the 12-month follow-up. |
| Recruiting |
| Dordrecht |
| Netherlands |
| Arbo Unie | Recruiting | Hengelo | Netherlands |
| Re-turn | Recruiting | Utrecht | Netherlands |
| Arbo Unie | Recruiting | Zeeland | Netherlands |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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