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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article 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trial Judith Michelle Mollet, Michiel Greidanus, Cécile Boot, Christiaan Vis, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5415750/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 16 Oct, 2025 Read the published version in Trials → Version 1 posted 6 You are reading this latest preprint version Abstract Background: The employer-based MiLES intervention is aimed at enhancing return to work (RTW) of employees with cancer through interactive video’s, conversation checklists, and tips and information. In a previous study, the MiLES intervention proved to be a useful intervention that aligns with employers’ daily practice. The hypothesis is that the MiLES intervention will enhance the employers’ willingness, ability, and self-efficacy in providing RTW support, which in turn will enhance the RTW of employees with cancer. This paper describes the design of a randomized controlled trial (RCT), aimed at evaluating the effectiveness, cost-effectiveness and return on investment of the MiLES intervention. Parallel to the RCT, a process evaluation of the delivery of the MiLES intervention in a real world setting will be conducted. Methods: An RCT with 12-month follow-up period will be conducted involving 140 employer-employee dyads. The employees are diagnosed with cancer (<2 years earlier), aged 18-67 years, in paid employment with an employer, and currently fully or partly sick-listed (<2 years). The employer is the individual providing RTW support to the included employee. All dyads will either be allocated to the intervention group, of which the employer will get access to the MiLES intervention, or to the control group in which care as usual will be provided. The primary outcome will be successful RTW (encompassing the employee’s perspectives on RTW) at the level of the employee, secondary outcomes will include: 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. Discussion: This RCT will study the effectiveness, cost-effectiveness and return on investment of the MiLES intervention. This knowledge is needed to formulate recommendations regarding implementation of the MiLES intervention beyond the research setting. Trial registration: ClinicalTrials.gov, NCT06672887. Registered on October 25, 2024. Cancer survivors Employee Employer Intervention Manager Neoplasm randomized controlled trial protocol Return to work Full Text Supplementary Files Appendix1.SPIRITchecklistMiLES2.0.docx Appendix 1. Completed SPIRIT checklist Appendix2.MiLESinformedconsentforms.docx Appendix 2. Informed consent form employee and employer Appendix3.OverviewofoutcomesMiLES.docx Appendix 3. Overview of primary and secondary outcomes Appendix4.WHOtrialregustrationdatasetMiLES.docx Appendix 4. World Health Organization Trial Registration Data Set Cite Share Download PDF Status: Published Journal Publication published 16 Oct, 2025 Read the published version in Trials → Version 1 posted Editorial decision: Major revision 14 Jul, 2025 Reviewers agreed at journal 01 Jul, 2025 Reviewers invited by journal 29 Mar, 2025 Editor invited by journal 12 Feb, 2025 Editor assigned by journal 29 Jan, 2025 First submitted to journal 08 Nov, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5415750","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":435626226,"identity":"b4a6c9fd-53f8-4783-86c1-02e7f98c4a42","order_by":0,"name":"Judith Michelle Mollet","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAElEQVRIiWNgGAWjYBACxgYwZSHDwMB8ACqWAKXZ8WqR4GFgYwMpNUDSwozXMpAWHgPitDA3cCcw3aiQ4OGX7/n46cafP3Lm7clPN/Pm2DGY49DC2MC7gTnnjASPZBvvZuncNgNjmTPPzG7zbktmsGzGoyW3TYLH4BjvBuncBoPEGRIJIC0HGAwOE9Bif4zn8e+cPwb1MyTSvxGnxYCNh006h80gQUIih4AtzbwbDoP8InEszcw6t83YcAbPm7Kbc7cl8+DSYtjeu/FxToWNHH/z4ce3c/7IyUuwp2+78XabnZzB8QbsWoDBcgCrDA92OxgY5HFJjIJRMApGwSiAAwBafFUzLKYBvQAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0009-0008-2381-4310","institution":"Amsterdam UMC - Locatie AMC: Amsterdam UMC Locatie AMC","correspondingAuthor":true,"prefix":"","firstName":"Judith","middleName":"Michelle","lastName":"Mollet","suffix":""},{"id":435626227,"identity":"24b78d07-53cf-48f6-8c84-bfe97cc608c7","order_by":1,"name":"Michiel Greidanus","email":"","orcid":"","institution":"Amsterdam UMC - Locatie AMC: Amsterdam UMC Locatie AMC","correspondingAuthor":false,"prefix":"","firstName":"Michiel","middleName":"","lastName":"Greidanus","suffix":""},{"id":435626228,"identity":"52fc0453-b4f2-48ef-a9e2-3fc0740fe71e","order_by":2,"name":"Cécile Boot","email":"","orcid":"","institution":"Amsterdam UMC - VUMC location: Amsterdam UMC Locatie VUmc","correspondingAuthor":false,"prefix":"","firstName":"Cécile","middleName":"","lastName":"Boot","suffix":""},{"id":435626229,"identity":"e655b357-a19a-442f-80ec-c00460062938","order_by":3,"name":"Christiaan Vis","email":"","orcid":"","institution":"Amsterdam UMC - Locatie VUMC: Amsterdam UMC Locatie VUmc","correspondingAuthor":false,"prefix":"","firstName":"Christiaan","middleName":"","lastName":"Vis","suffix":""},{"id":435626230,"identity":"00caad19-bd50-4d7f-a19f-57604b3d70a4","order_by":4,"name":"Johanna van Dongen","email":"","orcid":"","institution":"Vrije Universiteit Amsterdam","correspondingAuthor":false,"prefix":"","firstName":"Johanna","middleName":"van","lastName":"Dongen","suffix":""},{"id":435626231,"identity":"5ff9fbcb-d2d0-4eb1-b322-758e8b322d16","order_by":5,"name":"Angela de Boer","email":"","orcid":"","institution":"Amsterdam UMC - Locatie AMC: Amsterdam UMC Locatie AMC","correspondingAuthor":false,"prefix":"","firstName":"Angela","middleName":"","lastName":"de Boer","suffix":""},{"id":435626232,"identity":"f6b05aa8-0745-40ce-a0df-9f3cc2b91318","order_by":6,"name":"Sietske Tamminga","email":"","orcid":"","institution":"Amsterdam UMC - Locatie AMC: Amsterdam UMC Locatie AMC","correspondingAuthor":false,"prefix":"","firstName":"Sietske","middleName":"","lastName":"Tamminga","suffix":""}],"badges":[],"createdAt":"2024-11-08 10:23:17","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5415750/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5415750/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-025-09092-2","type":"published","date":"2025-10-16T15:56:50+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":93955767,"identity":"0cd77812-f59d-4b86-9289-30f268ec14d9","added_by":"auto","created_at":"2025-10-20 15:59:37","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":651187,"visible":true,"origin":"","legend":"","description":"","filename":"ProtocoldesignpaperMiLES2.0241102.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5415750/v1_covered_d3b78320-aa60-4217-947d-5e424b289e5b.pdf"},{"id":80851261,"identity":"8bc4b536-851e-4b00-a66f-f3a4ade1ee0f","added_by":"auto","created_at":"2025-04-17 18:44:33","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":41679,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 1. Completed SPIRIT checklist\u003c/p\u003e","description":"","filename":"Appendix1.SPIRITchecklistMiLES2.0.docx","url":"https://assets-eu.researchsquare.com/files/rs-5415750/v1/e916f00e2bf172a3984e9cae.docx"},{"id":80851264,"identity":"e7afeb4f-90b0-484c-ad0f-d021c34afbb4","added_by":"auto","created_at":"2025-04-17 18:44:33","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":32046,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 2. Informed consent form employee and employer\u003c/p\u003e","description":"","filename":"Appendix2.MiLESinformedconsentforms.docx","url":"https://assets-eu.researchsquare.com/files/rs-5415750/v1/f425d0412dedba2d12ef789d.docx"},{"id":80851265,"identity":"239999c5-134c-4dc8-88f5-4f5eb11370d3","added_by":"auto","created_at":"2025-04-17 18:44:33","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":29203,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 3. Overview of primary and secondary outcomes\u003c/p\u003e","description":"","filename":"Appendix3.OverviewofoutcomesMiLES.docx","url":"https://assets-eu.researchsquare.com/files/rs-5415750/v1/6ce15c0b68124c37f677c894.docx"},{"id":80851266,"identity":"d4bbec5a-4d64-4cf8-98f5-7255889cfb51","added_by":"auto","created_at":"2025-04-17 18:44:33","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":27049,"visible":true,"origin":"","legend":"\u003cp\u003eAppendix 4. 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In a previous study, the MiLES intervention proved to be a useful intervention that aligns with employers’ daily practice. The hypothesis is that the MiLES intervention will enhance the employers’ willingness, ability, and self-efficacy in providing RTW support, which in turn will enhance the RTW of employees with cancer. This paper describes the design of a randomized controlled trial (RCT), aimed at evaluating the effectiveness, cost-effectiveness and return on investment of the MiLES intervention. Parallel to the RCT, a process evaluation of the delivery of the MiLES intervention in a real world setting will be conducted.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMethods: An RCT with 12-month follow-up period will be conducted involving 140 employer-employee dyads. The employees are diagnosed with cancer (\u0026lt;2 years earlier), aged 18-67 years, in paid employment with an employer, and currently fully or partly sick-listed (\u0026lt;2 years). The employer is the individual providing RTW support to the included employee. All dyads will either be allocated to the intervention group, of which the employer will get access to the MiLES intervention, or to the control group in which care as usual will be provided. The primary outcome will be successful RTW (encompassing the employee’s perspectives on RTW) at the level of the employee, secondary outcomes will include: 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. 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