ONCORELIEF - A Digital Guardian Angel Supported by an AI System to Improve Cancer Patient Quality of Life, Wellbeing and Health Outcomes: Protocol for a Pilot Study (Preprint)

BACKGROUND According to the Europe’s Beating Cancer Plan the number of cancer survivors is growing every year and is now estimated at over 12 million in Europe. A main objective of the European Commission is to ensure that cancer survivors can enjoy a high quality of life, underlining the role of digital technology and eHealth applications and tools to achieve this. OBJECTIVE The main objective of this study is the development of a user-centered AI system to facilitate the input and integration of patient-related biopsychosocial data to improve post-treatment quality of life, wellbeing and health outcomes and examine the feasibility of this digitally assisted workflow in a real-life setting in patients with colorectal cancer (CRC) and acute myeloid leukemia (AML). METHODS A total of 60 patients with CRC and 30 with AML will be recruited from two clinical centers: Universitätsmedizin der Johannes Gutenberg-Universität Mainz (MAINZ, Germany) and IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” (IRST, Italy). Psychosocial data (e.g., emotional distress, fatigue, quality of life, subjective well-being, sleep problems, appetite loss) will be collected by questionnaires via a smartphone App, and physiological data (e.g., heart rate, skin temperature) movement (step count) will be collected by a customizable smart wrist-worn sensor device. Each patient will be assessed every 2 weeks over their 6-month participation on the ONCORELIEF study. Inclusion criteria: patients with diagnosis of acute myeloid leukemia (AML) or Colorectal cancer (CRC); adult patients ≥ 18 years old; life expectancy superior to 12 months; ECOG PS less or equal to 2 and have a smartphone and agree to use it for the purposes of the study. Exclusion criteria: patients with a reduced cognitive function (such as dementia) or technological illiteracy; other known active malignant neoplastic diseases (patients with medical history of treated neoplastic disease are included). RESULTS The pilot study started on 1 September 2022. As of January 2023, we enrolled 33 CRC patients and 7 AML patients. As of January 2023, we have not yet started the data analysis. We expect to get all data in June 2023 and expect the results to be published in the second semester of 2023. CONCLUSIONS A web application and a mobile application use methods from mathematical decision support and artificial intelligence through a closed-loop workflow that connects health professionals and patients. The ONCORELIEF system has the potential of continuously identifying, collecting, and processing data from diverse patient dimensions and to offer healthcare recommendations, supporting cancer patients to address their unmet needs and optimizing the survivorship care. CLINICALTRIAL German Clinical Trials Register (DRKS): 00027808