Effectiveness of Digital Remote Symptom Monitoring in Cancer Patients Using the Resilience PRO App (RC-102 Study)

Many patients with cancer suffer from side effects of their treatment or symptoms of their disease, which are often not discussed with their treating physicians until their next follow-up appointment. Promptly recording symptoms and adjusting treatment could help alleviate discomfort more quickly and improve care. Resilience PRO is a medical software that enables patients to regularly report their symptoms and well-being electronically (known as patient-reported outcomes, ePRO). The app analyzes this data and sends alerts to the treatment team when clinically significant symptoms are detected, so that the team can adjust therapy or supportive measures. The goal of this Phase 3 study is to determine whether using Resilience PRO in addition to standard medical care improves patients’ quality of life compared to standard care alone. Patients will be randomly assigned to two groups. The study arm uses the Resilience PRO app in addition to usual care. The control arm receives only standard medical care. The study is open-label, meaning that both medical staff and patients know which treatment group they have been assigned to. The primary endpoint of the study is health-related quality of life after 3 months, measured using a standardized questionnaire (EORTC QLQ-C30). In addition, health economic aspects, overall survival after 36 months, and the experiences of patients and medical staff will also be examined. Patients aged 18 and older with a cancer diagnosis (any stage) who are receiving systemic cancer therapy are eligible to participate. Prerequisites include owning a smartphone and being able to use the app. Excluded are patients with a life expectancy of less than 6 months, patients already participating in another remote monitoring study, and patients receiving a stem cell transplant or CAR-T cell therapy.