Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Jul 21;21(1):1433.
doi: 10.1186/s12889-021-11357-9.

A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

M A Greidanus  1 , A E de Rijk  2 , A G E M de Boer  3 , M E M M Bos  4 , P W Plaisier  5 , R M Smeenk  5 , M H W Frings-Dresen  3 , S J Tamminga  3
Affiliations
Randomized Controlled Trial

A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

M A Greidanus et al. BMC Public Health. .

Abstract

Background: Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors' successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained.

Methods: A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18-63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter.

Results: Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study's reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81-1.03); no difference were found with regard to secondary effect measures.

Conclusions: With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention.

Trial registration: The study has been registered in the Dutch Trial Register ( NL6758/NTR7627 ).

Keywords: Employer; Employment; Feasibility studies; Internet-based intervention; Manager; Neoplasms; Occupational health services; Pilot randomised controlled trial; Sick leave; Supervisor.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Recruitment and participant flow diagram. N/A = not applicable. *One hospital sent reminders to those who did not respond to the initial invitation within 3 weeks. Some survivors (n = 24) were no longer eligible at the time the reminders were sent, as their diagnosis was > 2 years earlier or they were > 63 years of age at that time. +Assessed in T2 questionnaire
See this image and copyright information in PMC

References

    1. Feuerstein M. Cancer survivorship and work. J Occup Rehabil. 2005;15(1):1–2. doi: 10.1007/s10926-005-0868-x. - DOI - PubMed
    1. Duijts S, Dalton SO, Lundh MH, Horsboel TA, Johansen C. Cancer survivors and return to work: current knowledge and future research. Psychooncology. 2017;26(5):715–717. doi: 10.1002/pon.4235. - DOI - PubMed
    1. Forman D, Bray F, Brewster D, Gombe Mbalawa C, Kohler B, Piñeros M, et al. Cancer incidence in five continents. Lyon: International Agency for Research on Cancer; 2014. - PubMed
    1. IKNL Integraal Kankercentrum Nederland. NKR Cijfers 2020 [Available from: cijfersoverkanker.nl.
    1. van Egmond MP, Duijts SFA, Loyen A, Vermeulen SJ, van der Beek AJ, Anema JR. Barriers and facilitators for return to work in cancer survivors with job loss experience: a focus group study. Eur J Cancer Care (Engl) 2017;26(5):e12420. doi: 10.1111/ecc.12420. - DOI - PMC - PubMed

Publication types

Associated data