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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Study protocol

The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial

Authors: Michiel A. Greidanus, Angela G. E. M. de Boer, Angelique E. de Rijk, Monique H. W. Frings-Dresen, Sietske J. Tamminga

Published in: Trials | Issue 1/2020

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Abstract

Background

Employers express a need for support to facilitate the return to work (RTW) process of employees with cancer. We have developed the MiLES intervention, an online toolbox targeting employers during the RTW of employees with cancer. To evaluate the MiLES intervention, we propose the design of a pilot randomised controlled trial (RCT). The aim of this pilot is to determine whether a future RCT to study the effectiveness of this intervention on successful RTW of employees with cancer is feasible. Secondary aims are to obtain preliminary results on the effectiveness of the intervention and to determine the sample size needed in a future definitive RCT.

Methods

A pilot RCT with a 6-month follow-up will be conducted. Using medical specialists at Dutch hospitals, we aim to enrol 90 participants diagnosed with cancer (<2 years earlier) aged 18–63 years who are in paid employment with an employer and who are currently sick-listed or partly sick-listed for <1 year. Participants randomised to the intervention group will be asked to inform their employer about the online toolbox supporting employers during the RTW process of employees with cancer. Participants in the control group will receive ‘care as usual’ from their employer. All measures will be assessed at the level of the employee using questionnaires at baseline and after 3 and 6 months of follow-up. The feasibility of a future RCT will be determined using criteria concerning method-related uncertainties and acceptability of the study protocol. The primary effect measure will be successful RTW (that is, RTW perceived as being successful by the cancer survivor themselves). This effect measure will be used to perform the sample size calculation for a future definitive RCT.

Discussion

The design is proposed to determine the feasibility to study the effectiveness of the MiLES intervention targeting employers on the successful RTW of employees diagnosed with cancer. This pilot RCT can increase the probability of a successful future definitive RCT on the effectiveness of the intervention and potentially obviate the need to carry out an unfeasible and resource-intensive study.

Trial registration

Dutch Trial Register (NTR): NL6758, NTR7627. Registered on 30 October 2018.
Appendix
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Metadata
Title
The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial
Authors
Michiel A. Greidanus
Angela G. E. M. de Boer
Angelique E. de Rijk
Monique H. W. Frings-Dresen
Sietske J. Tamminga
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04288-0

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