Study to Evaluate the Benefits of a Digital Health Application (DiGa: Medidux™)

Breast cancer is a malignant disease of the breast that primarily affects women. Since various biological characteristics of the tumor cells—such as hormone receptor status or HER2 status—shape the clinical picture, treatment approaches also vary. The goal of every treatment is to control tumor growth and maintain quality of life. However, side effects of the therapy may necessitate additional doctor’s visits or require an adjustment to the treatment.

The PRO2 study is investigating the use of the Medidux™ app, a medically approved smartphone application that patients use to document their health status. This includes vital signs such as blood pressure and pulse, general well-being, as well as scheduled and unscheduled visits to doctors.

The goal is to provide treating physicians with relevant information on the course of the disease and to support patients in managing side effects. As part of the study, patients are randomly assigned to either the intervention group (using the app) or the control group (not using the app). Both groups know which group they belong to (open-label study). The observation period lasts 12 to a maximum of 16 weeks, depending on the planned treatment. The actual cancer treatment is not affected by the use of the app.

Women and men aged 18 and older with HER2-positive breast cancer who are scheduled to receive combination therapy consisting of chemotherapy and HER2-targeted treatment are eligible to participate in the study. The breast cancer may be hormone receptor-positive or negative. A prerequisite is good overall health—participants should be able to perform light physical or sedentary activities (ECOG ≤ 1). In addition, patients must be familiar with using a smartphone in order to operate the app.