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

NCT06672887 | Recruiting Phase 2

• 1 other identifier: 2023.0524
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer; Neoplasm

Keywords

Cancer survivor; Employee with cancer; Employer; Return to work; Employment; Manager; Employee

Outcome Measures

Primary Outcomes (1)

• Successful return to work (employee with cancer)

  The primary effect measure "successful RTW" is a combination of two components: 1. Actual RTW: All employees will be asked about performed work activities in the past 4 weeks \[yes/no\]. This can be either their regular work activities or (temporarily) modified work activities. 2. Successful RTW (14-items): Employees who have resumed work (actual RTW is answered by "yes") will also be asked about the extent to which they perceive their RTW as "successful", using the I-RTW\_CS questionnaire. The I-RTW\_CS is specifically developed as an RTW outcome measure that represents the perspectives of employees with cancer, with items that could be influenced by an employer.

  From enrollment to the end of the 12-month follow-up.

Secondary Outcomes (7)

• Current work situation (employee with cancer)

  From enrollment to the end of the 12-month follow-up.

• Quality of life (employee with cancer)

  From enrollment to the end of the 12-month follow-up.

• Received work-related support from the employer (employee with cancer)

  From enrollment to the end of the 12-month follow-up.

• Satisfaction with work-related support from their employer (employee with cancer)

  From enrollment to the end of the 12-month follow-up.

• Quality of working life (employee with cancer)

  From enrollment to the end of the 12-month follow-up.

Other Outcomes (1)

• Cost-effectiveness and return on investment

  From enrollment to the end of the 12-month follow-up.

Study Arms (2)

Intervention group

EXPERIMENTAL

Employers randomized to the intervention group will get a personal link to the MiLES intervention.

Other: MiLES

Control group

NO INTERVENTION

The employees randomized to the control group will receive "care as usual" from their employer, as well as from their reintegration consultant or occupational physician. Their employer will not have access to the MiLES intervention during the study period. However, they will gain access for 6 months following a waiting-list period of 12 months.

Interventions

MiLES OTHER

The MiLES intervention is an open access website, accessible via an URL, but not traceable through any online search engine during the study period. Tailored for specific preferences and needs of different employees with cancer, the MiLES intervention consists of interactive videos, conversation checklists, tips and information regarding RTW guidance of employees with cancer, and an overview of involved stakeholders and relevant legislation. The MiLES intervention intends to optimize the RTW support the employer provides to the employee with cancer by enhancing the willingness and ability to implement the employer actions. The MiLES intervention focuses for example on fostering effective communication between the employer and employee, while disregarding assumptions based on previous experiences.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Dutch Cancer Society: collaborator
• Re-turn: collaborator
• Arbo Unie: collaborator

Study Sites (5)

Arbo Unie

Arnhem, Netherlands

RECRUITING

Arbo Unie

Dordrecht, Netherlands

RECRUITING

Arbo Unie

Hengelo, Netherlands

RECRUITING

Re-turn

Utrecht, Netherlands

RECRUITING

Arbo Unie

Zeeland, Netherlands

RECRUITING

Related Publications (1)

• Mollet JM, Greidanus MA, Boot CRL, Vis C, van Dongen JM, de Boer AGEM, Tamminga SJ. Effectiveness, cost-effectiveness, and return on investment of the web-based MiLES intervention targeted at employers, to enhance successful return to work of employees with cancer: design of a randomized controlled trial. Trials. 2025 Oct 16;26(1):417. doi: 10.1186/s13063-025-09092-2.

  PMID: 41102780 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sietske Tamminga, PhD

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Mollet, MSc

CONTACT

+31205669111; milesonderzoek@amsterdamumc.nl

Michiel Greidanus, PhD

CONTACT

+31205669111; m.a.greidanus@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded, as it was hard to devise a placebo intervention, and the standard care (no access to the MiLES intervention) was obviously different from the intervention (access to the MiLES intervention).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc researcher

Model Details: A non-blinded RCT. The investigators will include employer-employee with cancer dyads, and will compare an intervention group, in which the employer will get access to the MiLES intervention, with a control group, in which both the employee and employer will receive care as usual.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 4, 2024
• Study Start: December 18, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

NL (5)