CancerPhase 2/3MiLESNCT06672887
Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)
A Phase 2/3 study testing MiLES in people with Cancer and Neoplasm, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- MiLES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesNetherlands
- Study dates
- 18 Dec 2023to Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Arbo Unie
Arnhem
- Recruiting
Arbo Unie
Dordrecht
- Recruiting
Arbo Unie
Hengelo
- Recruiting
Re-turn
Utrecht
- Recruiting
Arbo Unie
Zeeland
About this study
Official title: 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
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- MiLES
- Keywords
- Cancer survivor, Employee with cancer, Employer, Return to work, Employment, Manager, Employee
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiLESOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Employers randomized to the intervention group will get a personal link to the MiLES intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful return to work (employee with cancer)
The primary effect measure "successful RTW" is a combination of two components:
- 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.
- 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.
Measured: From enrollment to the end of the 12-month follow-up.
Secondary outcomes (7)
Current work situation (employee with cancer)
Employees who have resumed work will be asked about their current work situation and since when they have returned to work (fully or partially). The questionnaire is self-developed and includes 9 items (e.g. time to RTW).
Measured: From enrollment to the end of the 12-month follow-up.
Quality of life (employee with cancer)
The SF-12 questionnaire will be used to measure the perceived impact of health on a participant's everyday life (12 items).
Measured: From enrollment to the end of the 12-month follow-up.
Received work-related support from the employer (employee with cancer)
Measured using self-developed questions, including the frequency of contact and its average duration (4-items).
Measured: From enrollment to the end of the 12-month follow-up.
Satisfaction with work-related support from their employer (employee with cancer)
Measured on a self-developed 5-point Likert scale (1 item).
Measured: From enrollment to the end of the 12-month follow-up.
Quality of working life (employee with cancer)
The Quality of Working Life Questionnaire for cancer survivors (QWLQ-CS) will be used to measure the experiences and perceptions at work over the past 4 weeks of employees who have resumed work.
Measured: From enrollment to the end of the 12-month follow-up.
Self-efficacy in providing return to work support (employer)
Measured using an adapted version of the Competence scale of empowerment questionnaire (4 items).
Measured: From enrollment to the end of the 12-month follow-up.
Satisfaction with RTW process (employer)
Measured on a self-developed 5-point Likert scale (1 item).
Measured: From enrollment to the end of the 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start18 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Re-turn, Arbo Unie
- Responsible party
- Principal investigator, Michiel Greidanus, Amsterdam UMC, location AMC
- Investigators
- Sietske Tamminga, PhD, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672887
- Sponsor's protocol ID
- 2023.0524
- Acronym
- MiLES
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet determined
Publications
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.
PubMed 41102780
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06672887
- Acronym / sponsor ID
- MiLES / 2023.0524
- Keywords
- Cancer survivor, Employee with cancer, Employer, Return to work, Employment, Manager, Employee
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Cancer Society, Re-turn, Arbo Unie
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: MiLESEmployers randomized to the intervention group will get a personal link to the MiLES intervention. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiLESThe 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. | Other | Intervention group |
Primary outcome
Successful return to work (employee with cancer)
Time frame: From enrollment to the end of the 12-month follow-up.
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.
7 secondary outcomes
Current work situation (employee with cancer)
Time frame: From enrollment to the end of the 12-month follow-up.
Quality of life (employee with cancer)
Time frame: From enrollment to the end of the 12-month follow-up.
Received work-related support from the employer (employee with cancer)
Time frame: From enrollment to the end of the 12-month follow-up.
Satisfaction with work-related support from their employer (employee with cancer)
Time frame: From enrollment to the end of the 12-month follow-up.
Quality of working life (employee with cancer)
Time frame: From enrollment to the end of the 12-month follow-up.
Self-efficacy in providing return to work support (employer)
Time frame: From enrollment to the end of the 12-month follow-up.
Satisfaction with RTW process (employer)
Time frame: From enrollment to the end of the 12-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Derived from this study: PubMed 41102780Mollet 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.
- Individual participant dataSharing planned: Undecided. Not yet determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sietske Tamminga, PhD principal investigator
Amsterdam UMC, location AMC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MiLES in people with Cancer and Neoplasm, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith Mollet, MSc (+31205669111, milesonderzoek@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful return to work (employee with cancer) (time frame: From enrollment to the end of the 12-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06672887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.