Clinical trial of innovative health app reimagines care for elderly women with breast cancer therapy induced cardiac toxicity

A clinical trial testing an innovative health app, which aims to prevent cardiotoxicity and improve the physical and mental health of breast cancer patients over the age of 60 who also have multiple long-term diseases, has now recruited 600 patients.   

Funded by the European Union’s Horizon 2020 research and innovation programme, CARDIOCARE is a five-year journey to empower patients to actively participate in their care — supporting not only their physical health but also their psychological resilience as they navigate the challenges of cancer. 

“CARDIOCARE offers a novel paradigm for managing the intertwined challenges of breast cancer and cardiovascular risk in elderly women with multimorbidity. By integrating AI-driven risk prediction, real-time data, and patient-reported outcomes, we are transforming clinical care into a continuous, personalized, and proactive process,” explained Doctor Georgia Karanasiou.   

“We have been impressed by the willingness of elderly patients — many in their 70s — to engage with wearable technologies and mobile apps, actively participating in their own care pathways. This challenges long-held assumptions about technology adoption in older populations. Even more striking is how receptive healthcare providers have been to integrating these tools into clinical practice when supported by robust evidence and actionable insights,” Dr Karanasiou added. 

All patients participating in the trial are equipped with the CARDIOCARE mobile app, which continuously monitors quality of life, mobility, and mental health using wearable chest and heart rate sensors, smartwatches, and validated patient-reported outcome questionnaires, enabling dynamic risk assessment and personalized care planning. 

Some participants will be randomly allocated to a group where the app additionally includes functions to encourage healthy behaviours such as increased physical activity, healthy diet, games to improve memory and cognitive functioning. 

CARDIOCARE is one of the first large-scale projects in Europe to integrate real-time wearable data, biomarkers, psychological profiling, and explainable AI into a personalized care pathway for a highly vulnerable population. It has been developed by a consortium of cardiologists, oncologists, psychologists, molecular biologists, bioinformaticians, computer scientists and biomedical engineers from seven countries across Europe - Greece, Italy, Cyprus, Slovenia, Sweden, the Netherlands and France. 

The project has already been successful in enabling the development of several AI-driven models to assist clinicians to personalise the heart and cancer care elderly breast cancer patients receive. The models are continuously validated using real-world data from CARDIOCARE prospective and retrospective clinical studies. 

“CARDIOCARE doesn’t just monitor risk—it anticipates it, learns from it, and acts on it. This means we can anticipate what patients need and use this intelligence directly to tailor how we care for patients.” Dr Karanasiou concluded. 

Elderly cancer patients are widely under-represented in cancer clinical trials which means there is a lack of evidence-based practices to best care for these patients. Older patients are also often more at risk of heart damage, also known as cardiotoxicity, as a result of cancer treatment.   

-ENDS- 

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Funding: CARDIOCARE has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 945175 

http://ec.europa.eu/digital-single-market/ehealth 

Disclosures: None  

References and notes:  

1. Brown C, Mantzaris M, Nicolaou E, et al. A systematic review of miRNAs as biomarkers for chemotherapy-induced cardiotoxicity in breast cancer patients reveals potentially clinically informative panels as well as key challenges in miRNA research. Cardio-Oncology. 2022;8(1):16. doi:10.1186/s40959-022-00142-1 

1. Stamoulou E, Spanakis C, Manikis GC, et al. Harmonization Strategies in Multicenter MRI-Based Radiomics. J Imaging. 2022;8(11):1-22. doi:10.3390/jimaging8110303  

1. Gkikas S, Tsiknakis M. Automatic assessment of pain based on deep learning methods: A systematic review. Comput Methods Programs Biomed. 2023;231:107365. doi:10.1016/j.cmpb.2023.107365  

1. Alexandraki A, Papageorgiou E, Zacharia M, et al. New Insights in the Era of Clinical Biomarkers as Potential Predictors of Systemic Therapy-Induced Cardiotoxicity in Women with Breast Cancer: A Systematic Review. Cancers (Basel). 2023;15(13):3290. doi:10.3390/cancers15133290  

1. Sacco G, Mazocco K, Constantinidou A, et al. An interdisciplinary ecosystem for the psychosocial and behavioural management of Cardiotoxicity in elderly breast cancer patient: a prospective clinical study (Preprint). JMIR Research Protocols. 2024 doi:10.2196/preprints.63455  

1. Skaramagkas V, Kyprakis I, Karanasiou G, et al. A Review on Deep Learning for Quality of Life Assessment Through the Use of Wearable Data. IEEE EMBS. 2025 doi: 10.1109/OJEMB.2025.3526457  

1. Manikis G, Kalliatakis G, Marias K, et al. Association of echocardiographic radiomics-based features with cardiotoxicity effect in breast cancer patients from the CARDIOCARE project. European Heart Journal – Cardiovascular Imaging 2025 doi: 10.1093/ehjci/jeae333.028  

1. Tsiouris K, Mitsis A, Grigoriadis G, et al. Risk Stratification for Cardiotoxicity in Breast Cancer Patients: Predicting Early Decline of LVEF After Treatment. 2023 IEEE 45th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) doi: 10.1109/EMBC40787.2023.10340316 

1. Casini C, Monzani D, Masiero M, et al. Incorporating psycho-social factors in cancer treatment adverse events studies. Ann Oncol. 2022;33:S1199. (poster presentation) doi:10.1016/j.annonc.2022.07.1535 

1. Karanasiou G, Grigoriadis G, Alexandraki A, et al. A multimodal approach for the management of co-morbid cardiotoxicity in the elderly breast cancer patients. Eur J Cancer. 2022;175:S40. (poster presentation) doi:10.1016/S0959-8049(22)01456-3 

Researchers involved will share latest developments of CARDIOCARE at a symposium at the European Society of Cardiology Cardio-Oncology 2025 Conference on June 20, 2025, in Florence, Italy. 

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