1. 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
- Author
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Mohamed Bouchahda, Ayhan Ulusakarya, Anne Thirot-Bidault, Elise Colle, Amal Attari, Rachel Bossevot, Malika Ali, Qi Huang, Agnès Fritsch, Gabrièle Breda, Pascal Hammel, Rene Adam, and Francis Levi
- Subjects
Cancer Research ,Oncology - Abstract
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 I7 data were teletransmitted. At baseline, rest-activity rhythm was robust for 7 pts (I97.5%) and disrupted for 2 pts (IoC 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.
- Published
- 2022
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