The BrEasT cancer afTER-CARE (BETTER-CARE) programme to improve breast cancer follow-up: design and feasibility study results of a cluster-randomised complex intervention trial
Anna Horn,
Julia Wendel,
Isabella Franke,
Armin Bauer,
Harald Baumeister,
Eileen Bendig,
Sara Y. Brucker,
Thomas M. Deutsch,
Patricia Garatva,
Kirsten Haas,
Lorenz Heil,
Klemens Hügen,
Helena Manger,
Rüdiger Pryss,
Viktoria Rücker,
Jessica Salmen,
Andrea Szczesny,
Carsten Vogel,
Markus Wallwiener,
Achim Wöckel,
Peter U. Heuschmann,
the BETTER-CARE Study Group
Affiliations
Anna Horn
Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg
Julia Wendel
Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg
Isabella Franke
Department of Gynecology and Obstetrics, University Hospital Würzburg
Armin Bauer
Institute Women’s Health GmbH
Harald Baumeister
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm
Eileen Bendig
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm
Sara Y. Brucker
Department of Women’s Health, University Women’s Hospital Tübingen
Thomas M. Deutsch
University Hospital Heidelberg
Patricia Garatva
Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm
Kirsten Haas
Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg
Lorenz Heil
Faculty of Business Management and Economics, Julius-Maximilians-Universität Würzburg
Klemens Hügen
University Hospital Würzburg, Clinical Trial Center Würzburg
Helena Manger
Faculty of Business Management and Economics, Julius-Maximilians-Universität Würzburg
Rüdiger Pryss
Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg
Viktoria Rücker
Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg
Jessica Salmen
Department of Gynecology and Obstetrics, University Hospital Würzburg
Andrea Szczesny
Faculty of Business Management and Economics, Julius-Maximilians-Universität Würzburg
Carsten Vogel
Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg
Markus Wallwiener
University Women’s Hospital Halle
Achim Wöckel
Department of Gynecology and Obstetrics, University Hospital Würzburg
Peter U. Heuschmann
Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg
Abstract 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.
