MELIORA Consortium will jointly work with local actors at different levels for the realization of eight (8) in total tailor-made lifestyle intervention and behavioural modification studies, including Artificial intelligence and digital tools, to promote sustainable behavioural changes among three target populations: i) healthy women at risk of developing breast cancer, ii) breast cancer patients and iii) breast cancer survivors. The studies will take place across 4 different European countries (Greece, Sweden, Spain and Lithuania) and 6 piloting centres targeting 2000 women in urban and rural areas including participants throughout the socioeconomic spectrum. Primary health care centres, hospitals or patients’/survivors’ organisations will be used as entry points to the community. The goal of the MELIORA Virtual Coach interventions is to evaluate its effectiveness, through assessing the effect of multiple individual and contextual factors to the uptake and sustainability of behavioural changes. At the same time, identification of specific bottlenecks and barriers that prevent the uptake of sustainable behavioural change will support the development of approaches on how to best reach and involve disadvantaged socio-economic population groups, vulnerable groups, and people living in rural areas, and will provide best practices for behavioural intervention uptake and scale-up. Regular monitoring will be ongoing during the implementation to allow corrective actions and ensure effective adaptation and uptake. Based on the study outcomes, the health economic evaluation and budget impact analysis, and data deriving from the scalability assessment, national and European stakeholders will be invited to evaluate, through workshops, the potential for adoption of the MELIORA Virtual Coach Interventions in other regions or countries in Europe. This action is part of the Cancer Mission cluster of projects on “Prevention & early detection (behavioural change).

The REBECCA proposal aspires to tap into the potential of Real-world Data (RWD) for supporting groundbreaking clinical research on complex chronic conditions (CCC) as a complement to Randomised Controlled Trials (RCT). REBECCA moves beyond the analysis of Electronic health records (EHR), by combining it with detailed monitoring data from multiple wearable, online behaviour and registry data to monitor patients’ functional, emotional and Quality of Life trajectories, with high temporal granularity. REBECCA also proposes explainable causal modelling combined with deep learning to account for observed and latent confounders in RWD analysis. The project will focus on the complex array of chronic comorbidities developed during breast cancer recovery, in particular studying the impact of primary and adjuvant cancer treatment on patients’ quality of life and assessing the value of detailed patient monitoring as a means for improved patient care, but will also demonstrate the extensibility of REBECCA to other forms of cancer. To this end, a total of seven studies in Sweden, Norway and Spain will produce new knowledge on clinical management of cancer patients that will shape future guidelines and practices for post-cancer treatments. Best practices resulting from the REBECCA studies will be disseminated to researchers, public health and regulatory bodies throughout Europe to facilitate wider adoption of RWD in clinical research. In addition, the REBECCA platform, capable of detailed monitoring and privacy-preserving federated cross-country data analysis, will provide an infrastructure for continued progress on use of RWD beyond the end of the project. Through these activities, REBECCA aims at the mass adoption of RWD for understanding CCCs and ultimately at establishing RWD as a valuable clinical research and patient management tool.