Kaiku Health is taking part in a study assessing the use of an electronic Patient-Reported Outcome (ePRO)-based model of care to evaluate onset of symptomatic immune-related adverse events in cancer patients and their detection by healthcare providers. This phase-II randomised controlled trial, comparing the ePRO-based model of care to the current standard model of care, is conducted at the Geneva University Hospitals and Lausanne University Hospital, Switzerland.
The patients participating in the trial are cancer patients treated with immune-checkpoint inhibitor (ICI) treatments. The patients will use Kaiku Health digital symptom monitoring and management platform to report their symptoms to their care teams. In the beginning of the treatment the patients will report their symptoms daily and then on a weekly basis. Clinical staff will review the symptom reports and help patients in managing them. This can include self-care advice, scheduling a consultation in the oncology department, or directing patients to the emergency department.
Early detection is a key factor in managing immune-related adverse events, which are common in ICI therapies and can be severe in nature.
“Between 60 and 85% of patients treated with a single immune checkpoint inhibitor experience at least one immune-related adverse event, about 20% of which are severe. With combined therapy the numbers are even higher: 95% of patients experience an immune-related adverse event of which 55% of are severe. Early detection and management lead potentially to more timely interventions which in turn could enable better experiences for patients and hopefully better treatment outcomes.”
explains Prof. Manuela Eicher, Associate professor and director of the Institute of Higher Education and Research in Healthcare at the Lausanne University and Lausanne University Hospital.
The current model of care, however, is based on pre-scheduled appointments, instead of symptom monitoring and alerts.
“In the current standard model of care, cancer patients treated with immunotherapies typically have follow-up consultations every two to three weeks. Even though patients are being educated on self-monitoring for potential adverse events, they can find it challenging to identify and connect symptoms to their treatment and to accurately report them at their follow-up appointment. The use of ePROs allows patients to report all symptoms in real time, which hopefully adds to patient safety. Furthermore ePROs have shown to enable the patients to properly report their symptoms, rather than having a healthcare staff member interpret and maybe over- or underestimate the symptom itself.”
states Dr. Alfredo Addeo, senior oncologist, from the Geneva University Hospitals.
Earlier studies have linked the use of ePROs with less decline in health-related quality of life as well as increased overall survival and decreased number of ER admissions of advanced cancer patients treated with chemotherapy. There is reason to expect that the use of ePROs would especially benefit patients treated with ICI therapies.
“Due to the importance of early detection of ICI treatment toxicities for their optimal management, the use of ePROs to monitor symptoms remotely represents a huge opportunity for patients treated with such therapies. However, even if previous studies have suggested a potential for this population to benefit from ePRO use, no randomized trials have been performed to date. This trial is the first of its kind, which only adds to its significance.”
concludes Prof. Olivier Michielin, Full professor and Head of the Precision Oncology Center of the Lausanne University Hospital.
The data collection started in November 2021 and will last for two years.