NCT06672887 Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)
| NCT ID | NCT06672887 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2023-12-18 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion criteria employees with cancer: * 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); * Currently fully or partly sick-listed (\<2 years); * Able to understand and read Dutch for filling out questionnaires; * Having already informed their employer about their diagnosis of cancer, or intending to do so; * Not yet applied or planning to apply for an invalidity benefit under the WIA. Inclusion criteria employers: * Supports and guides the participating employee with cancer during the period of sick leave and RTW. For example, as the direct supervisor or HR-manager; * Able to understand and read Dutch to be able to use the MiLES intervention and for filling out questionnaires; * Not yet familiar with the MiLES intervention. 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.
Contact & Investigator
Sietske Tamminga, PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location AMC
Frequently Asked Questions
Who can join the NCT06672887 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06672887 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06672887 currently recruiting?
Yes, NCT06672887 is actively recruiting participants. Contact the research team at milesonderzoek@amsterdamumc.nl for enrollment information.
Where is the NCT06672887 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Dordrecht, Netherlands, Hengelo, Netherlands, Utrecht, Netherlands and 1 additional location.
Who is sponsoring the NCT06672887 clinical trial?
NCT06672887 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Sietske Tamminga, PhD at Amsterdam UMC, location AMC. The trial plans to enroll 140 participants.
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