IMPACT - Implementing Patients' Competence in Oral Breast Cancer Therapy - a randomized, controlled study of standardized patient coaching versus patient management according to local practice for patients with HR positive HER2 negative metastatic breast cancer treated with Abemaciclib
Welslau M.1, Nabieva N.2,3, Decker T.4, Belleville E.5, Knapp O.5, Lothar H.3, Fasching P.6, Tesch H.7
1Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg, Aschaffenburg, Deutschland, 2Erlangen University Hospital, Department of Gynecology and Obstetrics, Erlangen, Deutschland, 3Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Erlangen, Deutschland, 4Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg, Ravensburg, Deutschland, 5ClinSol GmbH & Co. KG, Würzburg, Deutschland, 6Institut für Frauengesundheit GmbH (IFG) Erlangen, Erlangen, Deutschland, 7Centrum für Hämatologie und Onkologie Bethanien Frankfurt, Frankfurt am Main, Deutschland
Purpose: Oral agents, like CDK4/6 inhibitors, provide an attractive approach for the treatment of metastatic breast cancer. However, this type of therapy requires a high level of self-management competence by the patient. The non-interventional study (NIS) IMPACT intends to evaluate the effectiveness of a standardized patient education and coaching for therapy management provided by specially trained oncology nurses regarding persistence rate, side effects management and unplanned therapy interruptions in outpatient oncology care for patients under Abemaciclib treatment.
Methods: 212 Patients with HR+, HER2- metastatic breast cancer who are treated with Abemaciclib according to clinical routine will be enrolled in approx. 30 sites. Patients will be randomized to standardized patient coaching (based on MOATT©) or patient management according to local practice, respectively. Follow up is documented for a maximum of 24 weeks.
Results: Data of 212 MBC patients regarding a potential effect of standardized patient coaching on the persistence rate after 24 weeks of Abemaciclib therapy will be presented. Quality of live data as well as data regarding patient reported self-efficacy, side-effects, health related stress and therapy related knowledge will be presented.
Conclusions: The effectiveness of standardized patient coaching is observed and analyzed in a real-world setting to understand its benefits for MBC patients under Abemaciclib treatment with regard to therapy adherence and patient self-management competence.