Understanding Cardiac Events in Breast Cancer (UCARE) - Pilot Cardio-Oncology Assessment and Surveillance Pathway for Breast Cancer Patients

In Ireland, over 3,000 patients are diagnosed with breast cancer annually, and 1 in 9 Irish women will be diagnosed with breast cancer in their lifetime. There is evidence that female breast cancer survivors are more likely to die of cardiovascular disease than their age-matched counterparts. This protocol describes a prospective, single arm, pilot feasibility study implementing a dedicated Cardio-Oncology assessment and surveillance pathway for patients receiving multimodal breast cancer treatment. It incorporates novel biomarker and radiomic surveillance and monitoring approaches for cancer-therapy related cardiac dysfunction into routine care for breast cancer patients undergoing adjuvant systemic chemotherapy. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05921279 ### Funding Statement Irish Cancer Society, The National Breast Cancer Research Institute and Science Foundation Ireland each fund elements of this study. 1.0 FTE Cardio-Oncology Nurse has been funded through Irish Cancer Society, NBCRI and SFI (Prof. Wijns). Funds are managed through a grant portal through University of Galway Research office. Funding will cover staff costs and running costs for the project. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Galway University Hospital research ethics board I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data is available upon request. * CTRCD : Cancer Treatment Related Cardiac Dysfunction ESC : European Society of Cardiology QOL : Quality of life ECG : Electrocardiogram PIL : Patient information leaflet ICF : Informed consent form TTE : Transthoracic echocardiography HFA-ICOS : Heart Failure Association – International Cardio-Oncology Society EORTC : The European Organisation for Research and Treatment of Cancer IPAQ-SF : International Physical Activity Questionnaire Short Form KCCQ : Kansas City Cardiomyopathy Questionnaire PSS-10 : Perceived Stress Scale STAI : State Trait Anxiety Inventory HSE : Health Service Executive GDPR : General Data Protection Regulation ISF : Investigator site file