Periodic Reporting for period 2 - CAPABLE (CAncer PAtients Better Life Experience) Reporting period: 2021-07-01 to 2022-12-31 Summary of the context and overall objectives of the project Cancer patients today have a life expectancy never seen before, which is also associated with longer home treatment periods making many patients comparable to chronically ill patients. The disease must be monitored over the long term, while encouraging patients to adhere to therapy, even when adverse effects occur, empowering them and their caregivers in daily living, including facilitation for return to productive life. The overall objective of CAPABLE is to improve their quality of life, by combining the most advanced technologies with a sound socio-psychological approach. CAPABLE provides a patient’s coaching system and a doctor’s dashboard. Patients will be equipped with a smartphone and a smartwatch, to monitor their health status between control visits (see Figure). The app does not replace the doctor, but helps coping with mild/moderate adverse events, according to validated clinical practice guidelines. The app allows symptoms reporting and promote the patient's physical and mental well-being and adherence to therapies through a set of activities planned with the clinicians. The app also reminds entering some important data on a regular basis. Doctors will be provided with a web app, showing possible warnings, so that he can intervene promptly. Moreover, predictive prognostic models are implemented. Data from wearable devices will help following vital signs, sleep and physical activity. At the control visits, the doctors will be already informed of everything that happened since the last encounter, thus better using the limited time for a better understanding of the patient’s needs. The pilot studies will mainly involve patients with metastatic renal cell carcinoma and melanoma in 3 different clinical settings in Italy and the Netherlands. Other cancer types will be considered to test the generalisability of the application. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far First period (M1-M18)To coordinate the efforts of the 12 partners involved, 3 task forces have been set up, TF1 (technical development), TF2 (demonstrations), and TF3 (user interface), working on:- functional requirements, involving literature review, AIMAC forum content, and interviews with potential users in order to get feedback on the app mockups- implementation of the system components: the "case manager" coordinating all the other components; the "Data Platfom", providing a persistent data layer using the OMOP Common Data Model with some extensions; HL7 FHIR resources as standard for data exchange (6 resources developed); user interface mockups; physician decision support system implementing GLs, and the Virtual Coach, implementing the patient guide; two GLs (ESMO Diarrhoea and Immunotoxicity-section diarrhoea) have been modeled with the Composer tool, and validated by the oncologists; the component detecting recommendations or drug-drug interactions; the component implementing data abstractions; the AI-based predictive models- M12-demo (diarrhea guideline scenario ) and M18-demo (extended with predictive models)- harmonisation of the clinical pathways related to oncologists, psychologists and nutritionists' visits - enrollment of control patients for assessing basal values of QoL - market analysis and survey to detect possible competitors. A workshop was held to discuss the innovation potential of CAPABLE, how to compete and start paving options for business models- dissemination through website, conferences, scientific journals, local and national press. Moreover, we involved two artists with extensive experience in disseminating AI project results to broad audience (capable-project.eu/art-visualizations)Second period (M19-M36)Since this period has been devoted to the final system development, TF2 was no longer used and all the technical work has been coordinated by TF1, which monitored the evolution of all CAPABLE components. In particular, the last needed 4 FHIR resources have been implemented as well as the remaining GLs (Fatigue, Skin Toxicity and Mucositis). Furthermore a comprehensive testing (involving simulation of a high number of realistic clinical scenarios) and internal deployment strategy has been developed and the technical aspects connected to the different study phases (patient enrollment, clinical study execution, results gathering) have been agreed among the different partners. At the end of the reporting period, the system is in the final test phase before the starting of the pilot study.TF3 (User Interface) continued the process of collecting and handling the requirements. Those were collected in parallel with different prototypes preparation, carrying out an intensive (weekly) activity to implement and test the required functionalities. Moreover, since regulatory (ethical and legal) aspects are of paramount importance to finalise any study on human subjects, an additional task force, TF4, has been set up, caring for: preparing the study protocols to be submitted to Ethical Committees; preparing the notifications to the Ministry of Health, needed because CAPABLE is a medical device in risk class IIa; following the bureaucratic processes leading to all the necessary approvals.Additional progresses have been:- finalising the enrollment of the control patients cohort and provided a statistical analysis of the data collected, which will be considered as the baseline for the comparison with the data that will be collected during the pilot study;- continuing the activities devoted to the possible exploitation of the project results, in particular we started cooperation with the CS_AIW (Cancer Survivorship - AI for Well-being) cluster that collects 9 EU-funded projects wieth similar goals. Moreover, with the support of HRB PDES (Horizon Result Booster -- Portfolio Dissemination and Exploitation Strategy) we also formed a smaller cluster of 4 EU projects (CAPABLE, ASCAPE, BD4QL, and FAITH). Finally, at National level, CAPABLE entered the TAV (Lombardy Region Cluster for Ambient Assisted Living Technologies) cluster- enhancing the dissemination strategies. In particular, in addition to the "traditional" scientific publications on journals and conference proceedings, we posted a lot of contents on social media (Instagram, Facebook) and we promoted the project at local level through brochures and posters in the hospital waiting rooms. The artists' work so far available has been shown at the SMAU exposition in Milan.- enhancing the educational material accessible through the patient's app, in particular adding explanations and warnings for the execution of the physical exercises, and adding links to validated web contents. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Progress and impact- Adopting standards of communication and of vocabularies for data representation - Enhancing the GLs representation language with predictive models and multimorbidity management algorithms, - Incorporating AI into the patient’s app, to personalise as much as possible the virtual coach interventions. - Having the patient’s goals as the main focus in patients with multiple comorbidities, allowing detection and mitigation of drug-drug interactions, drug-disease interactions, and GLs recommendation conflicts- Providing novel and appealing modalities for presenting educational content to patients. - Delivering both mental and physical wellbeing interventions, considering the overall needs of cancer patients. - Delivering telemedicine/telemonitoring services also according to the needs realised during the Covid pandemics The overall functional architecture of the CAPABLE project
