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.
Authors: Bouchahda Mohamed , Ulusakarya Ayhan , Thirot-Bidault Anne , Colle Elise , Attari Amal , Bossevot Rachel , Ali Malika , Huang Qi , Fritsch Agnès , Breda Gabrièle , Hammel Pascal , Adam Rene , Levi Francis 
Published: June 2022

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 I<O of the circadian rest-activity rhythm (% activity In-bed below median activity Out-of-bed), one to four times daily. Alerts are automatically generated and sent to a coordination platform of health professionals, with trackable follow-up. Results: From 6/2021 to 2/2022, 16 of 42 planned pts (38%) from 4 centers have been included (females/males, 10/6 pts; aged 64-79 years; PS 0/1, 8/8 pts; 2 borderline/locally-advanced, and 14 metastatic (liver, 9; lymph nodes, 8; lung, 4). This technology report involves 9 pts on study for a median duration of 57 days (d) (range, 49-70d), whilst receiving 3 mFOLFIRINOX courses, with tumor control in 8 pts. Nearly 1.2x107 data were teletransmitted. At baseline, rest-activity rhythm was robust for 7 pts (I<O >97.5%) and disrupted for 2 pts (I<O <96%). Median compliance rates per pt (range) were 81% (67-92%) for rest-activity and body temperature, 96% (53-100%) for body weight, and 89% (78-100%) for self-rated e-PROMs. The median number of alerts generated for each pt (range) was 3 (0-10) for disrupted rest-activity rhythm (I<O <96%) or high temperature (2.5oC above median), and 2 (0-9) for body weight loss >5%, 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.