Horn A, Wendel J, Franke I, Bauer A, Baumeister H, Bendig E, Brucker SY, Deutsch TM, Garatva P, Haas K, Heil L, Hügen K, Manger H, Pryss R, Rücker V, Salmen J, Szczesny A, Vogel C, Wallwiener M, Wöckel A, and Heuschmann PU
Background: The risk of breast cancer patients for long-term side effects of therapy such as neurotoxicity and cardiotoxicity as well as late effects regarding comorbidities varies from individual to individual. Personalised follow-up care concepts that are tailored to individual needs and the risk of recurrences, side effects and late effects are lacking in routine care in Germany., Methods: We describe the methodology of BETTER-CARE, a parallel-arm cluster-randomised controlled trial conducted at 15 intervention and 15 control centres, aiming to recruit 1140 patients, and the results of the pilot phase. The needs- and risk-adapted complex intervention, based on existing development frameworks, includes a multidisciplinary network and digital platforms for symptom and need documentation and just-in-time adaptive interventions. The control group comprises usual care according to clinical guidelines. The primary outcome is health-related quality of life (EORTC QLQ-C30 global health), and secondary outcomes include treatment adherence., Results: The 2-month pilot phase comprising 16 patients in one intervention and one control pilot centre demonstrated the feasibility of the BETTER-CARE approach., Discussion: BETTER-CARE is a feasible intervention and study concept, investigating individualised needs- and risk-adapted breast cancer follow-up care in Germany. If successful, the approach could be implemented in German routine care., Trial Registration: German Clinical Trial Register DRKS00028840. Registered on April 2022., Competing Interests: Declarations Ethics approval and consent to participate The study was approved in April 2022 by the central ethics committee in Würzburg (registry number 12/22-sc). All centres have obtained approval by the local ethics committees before recruitment. Written informed consent was obtained from all subjects before study participation. Consent for publication Not applicable. Competing interests The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AH, JW, IF, AB, TMD, PG, KiH, LH, KH, HM, VR, AS, CV declare that they or a family member have not had any economic or personal ties in the last 3 years. HB reports research grants from the Federal Joint Committee (G-BA) within the Innovationfond, during the conduct of the study; royalties or licenses from HelloBetter, consulting fees from Roche, speaker honoraria as a member of the digital agenda BPtK and for E-Mental-Health Lectures DRV-BW, SAMA, Medical Centre Göppingen, and Participation on a Data Safety Monitoring Board for IMMERSE EU-Project. EB reports Honoraria for a workshop at “6. Hamburger Tag der Psychoonkologie ´Krebs und Innovation´ “. SYB reports research grants from the Federal Joint Committee (G-BA) within the Innovationfond, during the conduct of the study; Advisory board honoraria and speaker fees received from Medtronic, Sanofi, Köhler, AstraZeneca, Lilly, MSD, Hologic, Roche. JeS reports speaker honoraria received from AstraZeneca, Clovis Oncology, Dajichi Sanko, GILEDA, GSK, Lilly, Novartis Pharma GmbH, Pfizer, SEAGEN; support for attending meetings and/or travel received from Dajichi Sanko, GILEDA, Lilly. MW reports research grants from the Federal Joint Committee (G-BA) within the Innovationfond, during the conduct of the study; personal fees, non-financial support, speaker fees, consultancy honoraria or grants received from Novartis, Pfizer, Roche, Celgene, Daiichi Sankyo, AstraZeneca. RP reports research grants from the Federal Joint Committee (G-BA) within the Innovationfond, during the conduct of the study. AW reports research grants from the Federal Joint Committee (G-BA) within the Innovationfond, during the conduct of the study; consulting fees received from AstraZeneca, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, MSD, Pierre Fabre, Clovis, Organon, Seagen, Exact Sciences, Gilead, Dajichi Sanko; speaker honoraria received from Aurikamed and Onkowissen; support for attending meetings and/or travel received from Pfizer, Dajichi Sanko, Seagan; leadership or fiduciary role in AGO, S3-Guideline Breast Cancer, German Society of Breast Cancer, BGGF. PUH reports research grants from the Federal Joint Committee (G-BA) within the Innovationfond, during the conduct of the study; research grants from the German Ministry of Research and Education, Federal Joint Committee (G-BA), European Union, German Parkinson Society, University Hospital Würzburg, German Heart Foundation, German Research Foundation, Bavarian State, German Cancer Aid, Charité – Universitätsmedizin Berlin (within Mondafis; supported by an unrestricted research grant to the Charité from Bayer), University Göttingen (within FIND-AF randomised; supported by an unrestricted research grant to the University Göttingen from Boehringer-Ingelheim), University Hospital Heidelberg (within RASUNOA-prime; supported by an unrestricted research grant to the University Hospital Heidelberg from Bayer, BMS, Boehringer-Ingelheim, Daiichi Sankyo), outside the submitted work., (© 2024. The Author(s).)