A multicenter telemonitoring-telecare study with automatic assessment of physiological parameters and patient-reported outcomes in remote pancreatic cancer patients on mFOLFIRINOX: Interim technology report.

e13617 Background: There is an unmet need for improved treatment outcomes along with safer care of patients (pts) at home, at risk of severe adverse events from chemotherapy. Methods: MultiDom (NCT04263948; Ramsay Santé Research GCS) aims to reduce emergency hospitalisations of pancreatic adenocarcinoma pts on mFOLFIRINOX with a novel telemonitoring-telecare platform (Clinikali). Accelerometry and body temperature are measured q1-min using a continuously-worn telecommunicating chest surface sensor, daily body weight is self-measured with a telecommunicating balance, and 23 electronic pt-reported outcomes (ePROs) are self-rated using a tablet for 1 week before (baseline) and 6 weeks after the first course. Hidden Markov, spectrum and other algorithms automatically compute physical activity, sleep, temperature, body weight change, ePROs severity, and dichotomy index I97.5%) and disrupted for 2 pts (I5%, A median of 6 alerts per pt was generated for one or more severe ePROs (pain, 7 pts; fatigue, 6 pts; impact on activity, 5 pts; anorexia, 4 pts). Supportive treatment was mostly initiated at home, avoiding undue hospitalization. Pts rated the median global evaluation factor as 5 (4-5), i.e. the highest score, in the 23-items research participation questionnaire. Conclusions: Continuous multidimensional telemonitoring of physiology and e-PROs met excellent patient compliance, thus supporting exploration of biological mechanisms linking e-PROs to circadian rhythms and treatment activity. Study is ongoing to assess whether such telemonitoring-telecare platform may drive practice-changes in patient pathways and digitized clinical trials in the current era of precision medicine. Clinical trial information: NCT04263948.