The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial
Open Access
- 28 April 2020
- journal article
- research article
- Published by Springer Nature in Trials
- Vol. 21 (1), 1-11
- https://doi.org/10.1186/s13063-020-04288-0
Abstract
BackgroundEmployers 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.MethodsA 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 (<2years earlier) aged 18-63years who are in paid employment with an employer and who are currently sick-listed or partly sick-listed for <1year. 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.DiscussionThe 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.Keywords
Funding Information
- KWF Kankerbestrijding (UVA 2014-7153)
This publication has 49 references indexed in Scilit:
- Effectiveness of a Hospital-Based Work Support Intervention for Female Cancer Patients – A Multi-Centre Randomised Controlled TrialPLOS ONE, 2013
- Supporting ‘work‐related goals’ rather than ‘return to work’ after cancer? A systematic review and meta‐synthesis of 25 qualitative studiesPsycho‐Oncology, 2012
- Towards a New Definition of Return-to-Work Outcomes in Common Mental Disorders from a Multi-Stakeholder PerspectivePLOS ONE, 2012
- Breast cancer treatment and work disability: Patient perspectivesThe Breast, 2011
- Return-to-work interventions integrated into cancer care: a systematic reviewOccupational and Environmental Medicine, 2010
- What is a pilot or feasibility study? A review of current practice and editorial policyBMC Medical Research Methodology, 2010
- Experiences and concerns about ‘returning to work’ for women breast cancer survivors: a literature reviewPsycho‐Oncology, 2010
- A tutorial on pilot studies: the what, why and howBMC Medical Research Methodology, 2010
- How We Design Feasibility StudiesAmerican Journal of Preventive Medicine, 2009
- Relaxing the Rule of Ten Events per Variable in Logistic and Cox RegressionAmerican Journal of Epidemiology, 2006