Over its duration, the project designed, developed and deployed the REBECCA platform, an integrated infrastructure for collecting and analysing real-world data. The platform includes a patient mobile app (linked to commercial wearables), a companion app for caregivers, a web browser plug-in to capture online behaviour, and a clinical dashboard that allows researchers and health professionals to visualise patients’ trajectories over time. The final version of the platform was deployed in three countries and used in six prospective clinical studies involving breast cancer survivors and, in one study, prostate cancer patients.
The project enriched RWD with behavioural, lifestyle and physiological indicators. These cover mobility patterns, physical activity and heart rate, sleep, and aspects of emotional well-being inferred from patients’ online behaviours. REBECCA developed new “digital biomarkers” and data-driven models that summarise functional and emotional status. An Early Warning System was also implemented to flag abrupt changes in behaviour or adherence that may require attention.
To move beyond simple correlations, REBECCA developed and tested a full causal analysis framework for RWD. At the heart of this framework, Directed Acyclic Graphs capture the complex associations between treatments, behaviours, patient variables and patient-reported outcomes. A federated analysis library was developed to enable cross-country studies without sharing sensitive individual-level data.
On the clinical side, REBECCA successfully ran six studies in Sweden, Norway and Spain, ranging from observational studies to feasibility and intervention trials. These studies showed that continuous digital monitoring is feasible and acceptable to cancer patients, survivors and health care professionals. In one of the intervention trials, conducted in Spain, the REBECCA-assisted consultations were associated with statistically significant improvements in emotional and social functioning. Another intervention study in Norway found more modest, non-significant effects on physical functioning but still provided important insights. To support the delivery of REBECCA-assisted interventions, an “Advisory Guide for Health Care Professionals” was developed that links lifestyle advice to REBECCA measurements.
REBECCA placed strong emphasis on data protection, ethics and FAIR (Findable, Accessible, Interoperable, Reusable) data principles. The Data Management Plan and Data Protection Impact Assessment were kept up to date in line with recommendations from independent ethics advisors, and a public Zenodo community was created to host open deliverables, scientific publications and dataset metadata.
A comprehensive cost–benefit analysis using data from one of the intervention studies in Norway quantified the economic value of the REBECCA approach, indicating a positive cost–benefit ratio and suggesting that the intervention can become cost-effective after roughly two years in the examined scenario. This provides an important input for decision-makers considering reimbursement and wider deployment of similar solutions.
On the exploitation front, the consortium developed 14 individual exploitation plans for specific tools and services, 12 collaborative plans involving several partners, and a joint exploitation plan for the REBECCA platform, with a total of 28 exploitable assets identified. Dissemination activities were extensive, with numerous scientific and non-scientific publications, presentations at conferences and events, multiple newsletters and online campaigns, as well as engagement and collaboration with other EU-funded projects to align approaches and maximise impact.