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MiLES

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

MiLES · 1 trial · 2 indications

Phase 2 1
NCT06672887Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)Cancer
RECRUITING140 Analytics
PHASE2RECRUITING
Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)
CancerUnlock trial analytics

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 to 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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Frequently asked questions about MiLES

What is MiLES used for?

MiLES is an investigational intervention being studied for use in cancer. It is designed to support employers in enhancing the successful return to work of employees with cancer. The intervention is currently being evaluated in a Phase 2 clinical trial in the Netherlands.

Who makes MiLES?

MiLES is being developed by Turn Therapeutics Inc., a company traded under the ticker TTRX. The company is conducting a Phase 2 clinical trial to evaluate the intervention's effectiveness in supporting cancer patients' return to work.

What phase is MiLES in?

MiLES is currently in Phase 2 clinical development. It is an investigational intervention and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to assess its impact on return-to-work outcomes for cancer patients.

What clinical trials is MiLES in?

MiLES is being studied in one active Phase 2 clinical trial with the identifier NCT06672887. The trial, titled 'Enhancing Successful Return to Work of Employees With Cancer, by Supporting Employers (MiLES Intervention)', is recruiting 140 participants in the Netherlands and is open to adults aged 18 and older.

Is MiLES a randomized controlled trial?

Yes, the Phase 2 clinical trial of MiLES is randomized and controlled, but it is not double-blind. The control group receives no treatment, and the trial uses biomarker selection. The study is designed to evaluate the intervention's effect on return-to-work outcomes in cancer patients.