This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06675643.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Active
Contact: Svetomir Nenad Markovic
Phone: 507-284-2511
PRIMARY OBJECTIVES:
I. Optimize the patient (Aim 1) experience of the VIGILANT app workflow.
II. Gather preliminary data on the number of patients who develop Grade 3 + 4 irAE or require ER visit within 100 days of registration and treatment with IPI/NIVO.
OUTLINE: This is an observational study.
Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorSvetomir Nenad Markovic
