REBECCA – D7.4: Best practices for integration of multi-source RWD into existing clinical workflows

Executive Summary This deliverable presents the methodology and outcomes of co-creation and evidence synthesis activities conducted within the REBECCA project to support the integration of multi-source real-world data (RWD) into clinical workflows for breast cancer patient management. The REBECCA project, which was implemented between April 2021 and September 2025, aimed to leverage RWD collected from the patient application (pApp), smartphones, smartwatches, and patient-reported outcomes to complement traditional clinical research and enhance understanding of lifestyle, emotional well-being, and quality of life in breast cancer patients and survivors. The pApp is a mobile application for RWD collection that combines wearable connectivity, photo logging, short questionnaires, and GPS-based mobility tracking. A structured co-creation approach ensured that the digital tools developed were both clinically relevant and meaningful to patients. Breast cancer patients (BPCs), healthcare professionals (HCPs), and researchers from Sweden, Spain, and Norway actively participated in workshops, focus groups and validation sessions to enhance the integration of real-world data into existing clinical workflows. These collaborative efforts contributed to several improvements to the system and its usage. In this deliverable, we focus on two examples from the REBECCA project and analyse them as good practices for integrating RWD: the addition of the “Life Events” feature in the pApp and the creation of a unified advisory guide for HCPs. Specifically, in response to patient feedback, the “Life Events” feature was introduced in the pApp, replacing the original “environment stressor” annotation category. This change enabled patients to record both positive and negative daily experiences, offering a more balanced and comprehensive view of their life. Furthermore, to ensure consistent implementation of the REBECCA-assisted lifestyle consultations across the clinical sites, Karolinska Institutet developed a comprehensive advisory guide to support personalized lifestyle consultations. Drawing on international guidelines and adapting them to the REBECCA context, the guide was organized across six lifestyle domains plus an additional category of REBECCA-specific indicators, including mobility, work status, eating behaviours, and social support. The guide provided coded recommendations and practical examples to facilitate consistent, structured consultations by the HCPs across all clinical sites. The guide is publicly available as a standalone document on Zenodo at https://doi.org/10.5281/zenodo.17425256. Together, the enhanced reporting through the pApp and the development of the advisory guide for HCPs exemplify best practices for integrating patient-generated data into clinical workflows.