gms | German Medical Science

Gesundheit – gemeinsam. Kooperationstagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), Deutschen Gesellschaft für Sozialmedizin und Prävention (DGSMP), Deutschen Gesellschaft für Epidemiologie (DGEpi), Deutschen Gesellschaft für Medizinische Soziologie (DGMS) und der Deutschen Gesellschaft für Public Health (DGPH)

08.09. - 13.09.2024, Dresden

Article

Send article

Concept for a process evaluation of a needs- and risk-adapted complex intervention as part of the BrEasT cancer afTERcare program (BETTER-CARE)

Meeting Abstract

Search Medline for

  • Julia Wendel - Institute of Clinical Epidemiology and Biometry, Julius-Maximilians University Würzburg, Würzburg, Germany
  • Anna Horn - Institute of Clinical Epidemiology and Biometry, Julius-Maximilians University Würzburg, Würzburg, Germany
  • Viktoria Rücker - Institute of Clinical Epidemiology and Biometry, Julius-Maximilians University Würzburg, Würzburg, Germany
  • Armin Bauer - Institute Women’s Health GmbH, Tübingen, Germany
  • Harald Baumeister - Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany
  • Sara Brucker - University Hospital Tübingen, Tübingen, Germany
  • Thomas Maximilian Deutsch - University Hospital Heidelberg, Heidelberg, Germany
  • Isabella Franke - University Hospital Würzburg, Department of Gynecology and Obstetrics, Würzburg, Germany
  • Kirsten Haas - Institute of Clinical Epidemiology and Biometry, Julius-Maximilians University Würzburg, Würzburg, Germany
  • Klemens Hügen - Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany
  • Rüdiger Pryss - Institute of Clinical Epidemiology and Biometry, Julius-Maximilians University Würzburg, Würzburg, Germany; University Hospital Würzburg, Institute for medical Data Science, Würzburg, Germany
  • Kim-Alizee Schönberger - Institute of Clinical Epidemiology and Biometry, Julius-Maximilians University Würzburg, Würzburg, Germany
  • Andrea Szczesny - Faculty of Business Management and Economics, Julius-Maximilians-Universität Würzburg, Würzburg, Germany
  • Carsten Vogel - Institute of Clinical Epidemiology and Biometry, Julius-Maximilians University Würzburg, Würzburg, Germany
  • Achim Wöckel - University Hospital of Würzburg, Department of Gynaecology and Obstetrics, Würzburg, Germany
  • Peter Heuschmann - Institute of Clinical Epidemiology and Biometry, Julius-Maximilians University Würzburg, Würzburg, Germany; University Hospital Würzburg, Institute for medical Data Science, Würzburg, Germany

Gesundheit – gemeinsam. Kooperationstagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), Deutschen Gesellschaft für Sozialmedizin und Prävention (DGSMP), Deutschen Gesellschaft für Epidemiologie (DGEpi), Deutschen Gesellschaft für Medizinische Soziologie (DGMS) und der Deutschen Gesellschaft für Public Health (DGPH). Dresden, 08.-13.09.2024. Düsseldorf: German Medical Science GMS Publishing House; 2024. DocAbstr. 228

doi: 10.3205/24gmds320, urn:nbn:de:0183-24gmds3200

Published: September 6, 2024

© 2024 Wendel et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

Text

Introduction: The risk of long-term treatment side effects, including neurological and cardiac toxicities, as well as late effects associated with comorbidities varies among breast cancer patients. In routine care in Germany, there is a lack of personalized aftercare concepts that are specifically tailored to individual needs. As part of the cluster-randomized intervention study BETTER-CARE, a multidisciplinary network, digital platforms for symptom and needs documentation and digital applications with just-in-time adaptive interventions (JITAIs) are implemented. The aim is to optimize the follow-up care of patients after primary breast cancer.

Methods: A process evaluation will be conducted to assess the implementations in terms of the quality and delivery of the study intervention in the intervention regions, as well as its impact on primary and secondary endpoints (primary outcome: health-related quality of life). An analysis of intervention fidelity will be conducted to assess the extent to which the interventions were implemented according to the initial plans. Contextual factors influencing the intervention will be explored, identifying both facilitating and inhibiting factors. The research question will be addressed using a mixed-method approach.

Results: A comprehensive process evaluation concept was developed. This involves evaluating administrative data from the study coordination (e.g. number of signed cooperation agreements with gynecologists in private practice) as well as documentation from the study centers (e.g. screening logs, dropout lists). In addition, the usage data of the digital applications will be analyzed and an end-user version of the Mobile Application Rating Scale will be used to evaluate the quality of the application. The influence of contextual factors will be assessed using semi-structured interviews. We will conduct approximately 15 interviews with patients and aim to interview at least one representative from each intervention center. The first interviews with patients and participating centers are currently being conducted. Interim results will be presented at the time of the congress.

Implications: In the context of complex interventions, a process evaluation can be helpful to gain insight into the implementation process and its possible impact on the outcome of the study. A focus should therefore be placed on the development of a comprehensive evaluation concept for process evaluations.

The authors declare that they have no competing interests.

The authors declare that a positive ethics committee vote has been obtained.