Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Nov 14;25(1):767.
doi: 10.1186/s13063-024-08614-8.

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  1 , Julia Wendel  2 , Isabella Franke  3 , Armin Bauer  4 , Harald Baumeister  5 , Eileen Bendig  5 , Sara Y Brucker  6 , Thomas M Deutsch  7 , Patricia Garatva  5 , Kirsten Haas  2 , Lorenz Heil  8 , Klemens Hügen  9 , Helena Manger  8 , Rüdiger Pryss  2   10 , Viktoria Rücker  2 , Jessica Salmen  3 , Andrea Szczesny  8 , Carsten Vogel  2   10 , Markus Wallwiener  11 , Achim Wöckel #  3 , Peter U Heuschmann #  2   9   10 ; BETTER-CARE Study Group
Collaborators, Affiliations

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 et al. Trials. .

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.

Keywords: Breast cancer; Complex intervention; Follow-up care; Pilot study; Study protocol.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments of the BETTER-CARE trial
Fig. 2
Fig. 2
Trial course of control and intervention group in the BETTER-CARE trial. QLQ-FA-12, EORTC Quality of Life Module Measuring Cancer Related Fatigue; GAD-7, Generalised Anxiety Disorder 7-Item; PHQ-8, Patient Health Questionnaire 8-Item
Fig. 3
Fig. 3
The 30 participating centres of the BETTER-CARE trial: 15 intervention and 15 control regions. The graphic was created with R version 4.2.2 ©2022 The R Foundation for Statistical Computing, packages maps and mapadata
See this image and copyright information in PMC

References

    1. Sung H, Ferlay J, Siegel R, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Ca-a Cancer Journal For Clinicians. 2021;71(3):209–49. - PubMed
    1. Zentrum für Krebsregisterdaten, Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. Krebs in Deutschland für 2017/2018. Berlin: Robert-Koch-Institut; 2021. https://www.krebsdaten.de/Krebs/DE/Content/Publikationen/Krebs_in_Deutsc....
    1. Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, et al. Global surveillance of trends in cancer survival 2000–14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018;391(10125):1023–75. - PMC - PubMed
    1. Fiszer C, Dolbeault S, Sultan S, Bredart A. Prevalence, intensity, and predictors of the supportive care needs of women diagnosed with breast cancer: a systematic review. Psychooncology. 2014;23(4):361–74. - PubMed
    1. Faller H, Schuler M, Richard M, Heckl U, Weis J, Kuffner R. Effects of Psycho-Oncologic Interventions on Emotional Distress and Quality of Life in Adult Patients With Cancer: Systematic Review and Meta-Analysis. J Clin Oncol. 2013;31(6):782–93. - PubMed

Publication types

LinkOut - more resources