Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)

What this Trial Is About

This research aims to better understand how patients experience using a mobile app called Vigilant to monitor symptoms while receiving immune checkpoint inhibitor therapy for melanoma or other malignant skin cancers. The study also collects early data on the frequency of severe immune-related side effects or emergency room visits within 100 days after starting treatment with ipilimumab and nivolumab. This observational study focuses on the feasibility and potential clinical benefits of remote symptom monitoring. Participants receive standard treatment with the drugs ipilimumab and nivolumab. They use the Vigilant app to answer questions and report symptoms during their therapy. Those who wear a compatible smartwatch also have their vital signs recorded alongside symptom entries. Depending on symptom severity, the app may advise patients to contact their healthcare team or visit the emergency room. Participants also complete surveys and may have their medical records reviewed as part of the study. During the study, researchers monitor patient-reported symptoms, vital signs, survey responses, and medical chart data to assess the app's usability and ability to detect serious adverse events. The primary outcome measured is the rate of grade 3 or 4 immune-related side effects or emergency visits within 100 days of treatment start. The study involves ongoing remote symptom tracking and data collection while patients undergo standard care, lasting at least 100 days after treatment initiation.

Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App