A Phase 2/3 interventional study of MiLES in Cancer and Neoplasm, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 5 sites in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 2/3, Interventional, and Supportive care
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 140 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 185 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Employers randomized to the intervention group will get a personal link to the MiLES intervention.
Other: MiLES
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.
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.
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.
Time frame: From enrollment to the end of the 12-month follow-up.
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).
Time frame: From enrollment to the end of the 12-month follow-up.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: From enrollment to the end of the 12-month follow-up.
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).
Time frame: From enrollment to the end of the 12-month follow-up.
Plan to share: Undecided — Not yet determined
Started Dec 2023 (actual). Primary completion is estimated for Dec 2025, 24 months after the start.
Of 54 phase 2/3 interventional studies under Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 75. This study's planned 24 months is below that.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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