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MiLES

Phase 2

Cancer | Unknown | Oncology |Turn Therapeutics Inc.|Last Updated: Nov 4, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06672887Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)PHASE2 RECRUITING 140Dec 18, 2023Dec 1, 2025Nov 4, 20245 Netherlands
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Study Endpoints
Primary Endpoints
Successful return to work (employee with cancer)
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.

Secondary Endpoints
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.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
Intervention groupEXPERIMENTALEmployers randomized to the intervention group will get a personal link to the MiLES intervention.
Control groupNO_INTERVENTIONThe 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
NameTypeDescription
MiLESOTHERThe 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.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion criteria employees with cancer: * 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 occupationa...

Countries:Netherlands
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06672887studyFirstPostDate: changed