Periodic Reporting for period 3 - CAPABLE (CAncer PAtients Better Life Experience)
Periodo di rendicontazione: 2023-01-01 al 2024-01-31
The overall objective of CAPABLE is to improve quality of life (QoL) of cancer patients, by combining the most advanced technologies with a sound socio-psychological approach. CAPABLE provides a patient’s coaching system and a doctor’s dashboard. The latter allows patient's profiling and patients' data monitoring with alerts. Patients are equipped with a smartphone app, to monitor their health status between control visits and with a smartwatch for self monitoring of fitness parameters (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 promotes 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 are provided with a web app, showing possible warnings, so that they can intervene promptly. At the control visits, the doctors are 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 mainly involved patients with metastatic renal cell carcinoma and melanoma in 3 different clinical settings in Italy and the Netherlands. Patients with other cancer types have been enrolled to test the generalisability of the application. The primary outcome of our project is the QoL, which was measured through validated questionnaires at the beginning, in the middle and at the end of the study period (minimum 6 months). Values measured for the "CAPABLE patients" were compared with values measured in a cohort of patients that did not use the system. Results show that CAPABLE improves the patients' QoL.
First period (M1-M18)
we set up 3 task forces: 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; HL7 FHIR resources as standard for data exchange; user interface mockups; physician decision support system implementing GLs, and the Virtual Coach, implementing the patient guide;
- 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/national press. We also involved two artists with extensive experience in disseminating AI project results to broad audience (capable-project.eu/art-visualizations)
Second period (M19-M36)
Being this period devoted to the final system development, TF2 was no longer used and technical work was coordinated by TF1, which monitored the evolution of all CAPABLE components. 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;
- continuing the activities devoted to the possible exploitation of the project results: cooperation with the CS_AIW cluster that collects 9 EU-funded projects wieth similar goals. Moreover, with the support of HRB PDES, we also formed a smaller cluster of 4 EU projects. Finally, at National level, CAPABLE entered the TAV (Lombardy Region Cluster for Ambient Assisted Living Technologies) cluster
- enhancing the dissemination strategies. In particular, 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.
Third Period (M37-M49)
- finalising the system deployment at ICSM and NKI hospitals
- finalising the legal steps for the notifications of the app as medical devices
- enrolling the patients in the pilot studies (56 in Italy and 31 in the Netherlands)
- monitoring the system status (the correct functioning of each component)
- organising events to maintain the patients' engagement (such as focus groups, workshops, exhibitions, etc)
- evaluation of the results by analysing the collected data (QoL trend over time was improved in Capable cohort with respect to the control cohort)
- continuing the dissemination and exploitation activities (10 dissemination events, 6 journal papers, 6 international workshop papers and 1 book chapter)
we set up 3 task forces: 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; HL7 FHIR resources as standard for data exchange; user interface mockups; physician decision support system implementing GLs, and the Virtual Coach, implementing the patient guide;
- 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/national press. We also involved two artists with extensive experience in disseminating AI project results to broad audience (capable-project.eu/art-visualizations)
Second period (M19-M36)
Being this period devoted to the final system development, TF2 was no longer used and technical work was coordinated by TF1, which monitored the evolution of all CAPABLE components. 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;
- continuing the activities devoted to the possible exploitation of the project results: cooperation with the CS_AIW cluster that collects 9 EU-funded projects wieth similar goals. Moreover, with the support of HRB PDES, we also formed a smaller cluster of 4 EU projects. Finally, at National level, CAPABLE entered the TAV (Lombardy Region Cluster for Ambient Assisted Living Technologies) cluster
- enhancing the dissemination strategies. In particular, 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.
Third Period (M37-M49)
- finalising the system deployment at ICSM and NKI hospitals
- finalising the legal steps for the notifications of the app as medical devices
- enrolling the patients in the pilot studies (56 in Italy and 31 in the Netherlands)
- monitoring the system status (the correct functioning of each component)
- organising events to maintain the patients' engagement (such as focus groups, workshops, exhibitions, etc)
- evaluation of the results by analysing the collected data (QoL trend over time was improved in Capable cohort with respect to the control cohort)
- continuing the dissemination and exploitation activities (10 dissemination events, 6 journal papers, 6 international workshop papers and 1 book chapter)
Progress and impact
- Adopting standards of communication and of vocabularies for data representation (CAPABLE also contributed to SNOMED enrichment)
- 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
- Demonstrating the usabiliy and acceptability of the solution, considering the complexity due to the involvement of a multidisciplinary medical team (ocologists, nutritionists, psychologists)
- As mantioned, results show that CAPABLE is effective in improving the QoL. A preliminary cost analysis has also been performed to show the economic sustainability of such a solution.
- Adopting standards of communication and of vocabularies for data representation (CAPABLE also contributed to SNOMED enrichment)
- 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
- Demonstrating the usabiliy and acceptability of the solution, considering the complexity due to the involvement of a multidisciplinary medical team (ocologists, nutritionists, psychologists)
- As mantioned, results show that CAPABLE is effective in improving the QoL. A preliminary cost analysis has also been performed to show the economic sustainability of such a solution.