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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-18

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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The investigators will include 140 employer-employees with cancer dyads. The employees are diagnosed with cancer (\<2 years earlier), aged 18-65 years, in paid employment with an employer, and currently fully or partly sick-listed (\<2 years). The employer supports and guides the participating employee with cancer during the period of sick leave and RTW (e.g. as the direct supervisor or HR-manager).

Employers of dyads randomized to the intervention group will get unlimited access to the web-based MiLES intervention, aimed at enhancing the successful RTW of employees with cancer, by supporting employers. This intervention includes among others interactive video's, conversation checklists, and tips and information. Employers of dyads randomized to the control group will not get access to the MiLES intervention, thus dyads will get care as usual.

The primary outcome will be successful RTW, measured at the level of the employee. Secondary outcomes will include: current work situation (including time to RTW), quality of life and quality of working life, received work-related support, and satisfaction with work-related support. At the level of the employer, the secondary outcomes will include: self-efficacy in providing RTW support, and satisfaction with the RTW process. All outcomes will be assessed using questionnaires at baseline and at 3, 6 and 12 months of follow-up. Both the cost-effectiveness and the return on investment analysis will be conducted from the employers perspective. For the process evaluation, the UK MRC framework will be used.

Conditions

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Cancer Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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).

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

MiLES

Intervention Type 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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MiLES

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 Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

\- 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes