NCT05425550

Evaluation of the Medidux™ Digital Health Application in Patients With HER2-positive Breast Cancer.

Evaluation of the Medidux™ Digital Health Application in Patients With HER2-positive Breast Cancer During Chemotherapy in Combination With HER2-targeted Therapy (Including Tyrosine Kinase Inhibitors [TKI]) or an Antibody-drug Conjugate Therapy: a Multicenter Randomized Controlled Trial.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Palleos Healthcare GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, prospective, randomised and controlled study to evaluate the medidux™ app during an observation period of 12 weeks (maximum 16 weeks in case of shifts in the initially planned therapy).

Detailed description

The PRO2 study is being conducted by palleos healthcare GmbH, the sponsor of the study, with the participation of an expected 585 patients at 40 study sites in Germany and 10 study sites in the German-speaking part of Switzerland with the aim of investigating the medical benefit of the smartphone application medidux™ (app) with regard to the occurrence of side effects in breast cancer therapy. Furthermore, the potential impact on the application of the chemotherapy or antibody-drug conjugate, respectively, the number of unplanned doctor visits, as well as hospitalizations and how often the app is used will be investigated. The app was developed by mobile Health AG and is intended to accompany therapy. It is an approved CE-marked medical device that will be used in the study within the intended purpose. Study participants can use the app to document symptoms and well-being, as well as vital signs (e.g., blood pressure), and complete a test that can be used to assess mental performance. The entries can be viewed by the study physician through the medidux™ web application. The study participants can refer to the entries during the treatment visit to explain the course of therapy and perceived symptoms. As part of the study, use of the app will be compared to the normal treatment routine (without the app). A randomization process will determine whether study participants receive the app. The probability of receiving the app is 50%. If study participants receive the app, it can be used after installation on the personal smartphone. The approximately 12- to a maximum of 16-week observation period begins with the regular breast cancer therapy. The specific treatment of the breast cancer is not interfered with during the study, i.e. the administration of the therapy itself is carried out in the same way as it would be without the app.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	medidux™ app	Use of the regular medidux™ application for 12 (maximum 16) weeks

Timeline

• Start date: 2022-08-29
• Primary completion: 2025-06-05
• Completion: 2025-06-05
• First posted: 2022-06-21
• Last updated: 2025-09-22

Locations

1 site across 1 country: Switzerland