Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06672887

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

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-11-04

140

Participants Needed

5

Research Sites

102 weeks

Total Duration

On this page

Sponsors

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

D

Dutch Cancer Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with cancer less than 2 years ago
  • Between 18 and 65 years old
  • Currently in paid employment with an employer
  • Receiving support from an occupational physician or reintegration consultant
  • Currently fully or partly sick-listed for less than 2 years
  • Able to understand and read Dutch to complete questionnaires
  • Have informed or plan to inform their employer about their cancer diagnosis
  • Not applied or planning to apply for an invalidity benefit under the WIA
  • Employer supports the employee during sick leave and return to work (e.g., supervisor or HR manager)
  • Employer able to understand and read Dutch to use the MiLES intervention and complete questionnaires
  • Employer not previously familiar with the MiLES intervention
Not Eligible

You will not qualify if you...

  • Employees and employers must participate together as a dyad; if one cannot or will not participate, the other cannot participate either

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Trial Site Locations

Total: 5 locations

1

Arbo Unie

Arnhem, Netherlands

Actively Recruiting

2

Arbo Unie

Dordrecht, Netherlands

Actively Recruiting

3

Arbo Unie

Hengelo, Netherlands

Actively Recruiting

4

Re-turn

Utrecht, Netherlands

Actively Recruiting

5

Arbo Unie

Zeeland, Netherlands

Actively Recruiting

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Research Team

J

Judith Mollet, MSc

CONTACT

M

Michiel Greidanus, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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