Periodic Reporting for period 1 - CARDIOCARE (AN INTERDISCIPLINARY APPROACH FOR THE MANAGEMENT OF THE ELDERLY MULTIMORBID PATIENT WITH BREAST CANCER THERAPY INDUCED CARDIAC TOXICITY)
Période du rapport: 2021-07-01 au 2022-12-31
Breast cancer is the most diagnosed cancer in Europe, accounting for 13,3% of all new cancer cases in 2020. Female breast cancer is the most frequent cancer reaching 355.000 cases in EU-27 in 2020. 1 in 11 women in EU-27 will develop breast cancer by the age of 74. About half of all new breast cancer patients are diagnosed at the age of 65 and above. Although breast cancer mortality rates have been declining each year in Europe, one of the main causes of non-cancer related death in women with breast cancer over the age of 50 is cardiotoxicity. Cardiotoxicity is the damage caused to the heart due to the cancer therapy complications, reducing life expectancy and Quality of Life significantly. The majority of the newly diagnosed breast cancer patients are older than 65 years of age, adding further complexity to the management and care of this patient population. Currently evidence-based best practices for risk stratification and management of the elderly cancer patients, including older women with breast cancer, are still lacking.
CARDIOCARE is an ambitious 5-year project which aims to rationally change the current state-of-the-art in the management of co-morbid cardiotoxicity in the elderly breast cancer patients. CARDIOCARE provides comprehensive solutions and actionable insights to assist prevention, improved stratification, early detection, and treatment of cardiotoxicity in the elderly breast cancer patients focusing on interventions for preserving the Quality of Life and intrinsic capacity in order to improve healthcare pathways.
To achieve its objectives, the consortium of CARDIOCARE is composed of highly multidisciplinary group of researchers with remarkable track record and complementarity. The CARDIOCARE consortium encompasses partners from 6 clinical centers, 3 private companies (2 SMEs), 1 research institute and 2 universities. Key partner of the project is the European Society of Cardiology, a world leader in the dissemination of best practices in cardiovascular medicine.
CARDIOCARE is an ambitious 5-year project which aims to rationally change the current state-of-the-art in the management of co-morbid cardiotoxicity in the elderly breast cancer patients. CARDIOCARE provides comprehensive solutions and actionable insights to assist prevention, improved stratification, early detection, and treatment of cardiotoxicity in the elderly breast cancer patients focusing on interventions for preserving the Quality of Life and intrinsic capacity in order to improve healthcare pathways.
To achieve its objectives, the consortium of CARDIOCARE is composed of highly multidisciplinary group of researchers with remarkable track record and complementarity. The CARDIOCARE consortium encompasses partners from 6 clinical centers, 3 private companies (2 SMEs), 1 research institute and 2 universities. Key partner of the project is the European Society of Cardiology, a world leader in the dissemination of best practices in cardiovascular medicine.
The technical progress of the project follows the principles and work described in the Grant Agreement. More specifically, all the tasks which have started are implemented and critical objectives are progressing according to the plan.
Following a detailed literature review and analysis and a Delphi study, Key Performance Indicators have been identified and have yielded the selection of self-reported measures to be included in the CARDIOCARE mobile application. Literature review allowed the development of specific interventions for breast cancer patients with cardiological problems which are to be included in the eHealtHeart app. The eHealth patient-oriented CARDIOCARE application has been developed and includes two sub-applications: (i) the ePsycHeart mobile application, and (ii) the eHealtHeart mobile application, for enabling efficient monitoring of health status and QoL and implementation of behavioural and psychological interventions.
The validated novel set of the key performance indicators including new imaging, biochemical and molecular (SNPs, miRNAs, microbiome) biomarkers and psycho-markers will be performed as soon as data from the clinical study are being collected and analyzed through the application of the risk stratification models. In this phase, there are candidate indicators to be considered. Regarding the biochemical and molecular biomarkers, a detailed protocol for the collection of bio-samples for biomarker discovery from patients in the prospective clinical study was designed and agreed among the project consortium.
For the development and validation of the machine learning risk stratification models, retrospective and prospective data are used. Currently the retrospective data collection is completed, with data collected from 1587 unique patients out of a total of 1,560 expected in the DoA. The analysis is performed using: (i) Non- imaging and (ii) Imaging data. The measurements that have been collected from each clinical site were analyzed to ensure that the same features were correctly identified and assigned to their equivalent feature IDs in the collective retrospective database. On imaging data, various deep learning segmentation networks have been developed for delineating cardiac structures using two-dimensional (2D) echocardiography images. At this stage of development, publicly available data that consist of 2D echocardiographic sequences and their corresponding annotations have been used for the segmentation models.
The study protocol to collect data to fine tune the cardiotoxicity predictive model and to test the efficacy of behavioral and psychological interventions included in the CARDIOCARE mobile applications was developed. Analytical definitions of all aspects of the clinical study have been defined in close collaboration and interaction with the technical partners. Ethical issues associated with data privacy protection have been discussed to share data within the consortium..
In this period, we have also performed an initial design of the platform architecture and delivered a first version of the platform for multi-dimensional data collection, harmonisation, storage and processing and provision of eHealth services implementing appropriate privacy and data protection principles.
Project related communication and dissemination activities started with the presentation of the project identity kit (logo, color guide and typeface) at the end of M1. Until the end of the first reporting period, the consortium delivered the following relevant outcomes: 1 website (URL: https://cardiocare-project.eu/) 3 social media channels, 3 posters, 2 brochures, 2 newsletters, 3 press releases, 2 videos, 6 conference presentations (3 regarding the overall project presentation and 3 regarding individual project results), 1 journal publication, 5 events (for communicating the project and its objectives to patient association and healthcare experts), 1 Workshop @ IEEE BHI conference, 7 synergies with other EU funded programs. In what concerns the exploitation, a preliminary analysis has been performed. In more detail, in this period, we defined the initial exploitable assets of CARDIOCARE project and the main users. We also defined the business model canvas for the identified exploitable assets providing details on the: key partners, key activities, key resources, value propositions, customer segments and relationships, channels, cost structure and revenue streams.
Finally, preliminary considerations on regulatory and ethical aspects have been already developed.
Following a detailed literature review and analysis and a Delphi study, Key Performance Indicators have been identified and have yielded the selection of self-reported measures to be included in the CARDIOCARE mobile application. Literature review allowed the development of specific interventions for breast cancer patients with cardiological problems which are to be included in the eHealtHeart app. The eHealth patient-oriented CARDIOCARE application has been developed and includes two sub-applications: (i) the ePsycHeart mobile application, and (ii) the eHealtHeart mobile application, for enabling efficient monitoring of health status and QoL and implementation of behavioural and psychological interventions.
The validated novel set of the key performance indicators including new imaging, biochemical and molecular (SNPs, miRNAs, microbiome) biomarkers and psycho-markers will be performed as soon as data from the clinical study are being collected and analyzed through the application of the risk stratification models. In this phase, there are candidate indicators to be considered. Regarding the biochemical and molecular biomarkers, a detailed protocol for the collection of bio-samples for biomarker discovery from patients in the prospective clinical study was designed and agreed among the project consortium.
For the development and validation of the machine learning risk stratification models, retrospective and prospective data are used. Currently the retrospective data collection is completed, with data collected from 1587 unique patients out of a total of 1,560 expected in the DoA. The analysis is performed using: (i) Non- imaging and (ii) Imaging data. The measurements that have been collected from each clinical site were analyzed to ensure that the same features were correctly identified and assigned to their equivalent feature IDs in the collective retrospective database. On imaging data, various deep learning segmentation networks have been developed for delineating cardiac structures using two-dimensional (2D) echocardiography images. At this stage of development, publicly available data that consist of 2D echocardiographic sequences and their corresponding annotations have been used for the segmentation models.
The study protocol to collect data to fine tune the cardiotoxicity predictive model and to test the efficacy of behavioral and psychological interventions included in the CARDIOCARE mobile applications was developed. Analytical definitions of all aspects of the clinical study have been defined in close collaboration and interaction with the technical partners. Ethical issues associated with data privacy protection have been discussed to share data within the consortium..
In this period, we have also performed an initial design of the platform architecture and delivered a first version of the platform for multi-dimensional data collection, harmonisation, storage and processing and provision of eHealth services implementing appropriate privacy and data protection principles.
Project related communication and dissemination activities started with the presentation of the project identity kit (logo, color guide and typeface) at the end of M1. Until the end of the first reporting period, the consortium delivered the following relevant outcomes: 1 website (URL: https://cardiocare-project.eu/) 3 social media channels, 3 posters, 2 brochures, 2 newsletters, 3 press releases, 2 videos, 6 conference presentations (3 regarding the overall project presentation and 3 regarding individual project results), 1 journal publication, 5 events (for communicating the project and its objectives to patient association and healthcare experts), 1 Workshop @ IEEE BHI conference, 7 synergies with other EU funded programs. In what concerns the exploitation, a preliminary analysis has been performed. In more detail, in this period, we defined the initial exploitable assets of CARDIOCARE project and the main users. We also defined the business model canvas for the identified exploitable assets providing details on the: key partners, key activities, key resources, value propositions, customer segments and relationships, channels, cost structure and revenue streams.
Finally, preliminary considerations on regulatory and ethical aspects have been already developed.
The project will employ an interdisciplinary patient-oriented approach by acquiring, processing and analyzing multidimensional datasets. Data will be obtained retrospectively from the available records of the participating hospitals and a multimodal dataset will be generated through a prospective clinical trial designed and executed as part of the CARDIOCARE project.
During the study, imaging, biochemical and molecular data will be combined with wearable devices and sensors, user application inputs, patient and caregiver questionnaires. Data will be stored, managed and processed using a data management platform while state-of-the-art algorithms will be developed and deployed for delivering a risk prediction model to assist clinical decision making towards better health and care, economic growth and sustainability of health systems.
During the study, imaging, biochemical and molecular data will be combined with wearable devices and sensors, user application inputs, patient and caregiver questionnaires. Data will be stored, managed and processed using a data management platform while state-of-the-art algorithms will be developed and deployed for delivering a risk prediction model to assist clinical decision making towards better health and care, economic growth and sustainability of health systems.