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Publications

Journal Article Clinical Trial Protocol Epublish

PubMed: 40810441 DOI: 10.2196/63455

An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study.

JMIR Res Protoc 14:e63455

Authors: Gaia Giulia Angela Sacco, Ketti Mazzocco, Anastasia Constantinidou, Andri Papakonstantinou, Davide Mauri, Grigorios Kalliatakis, Manolis Tsiknakis, Domen Ribnikar, Dorothea Tsekoura, Valantis Aidarinis, Kalliopi Keramida, Panagiotis Oikonomopoulos, Athos Antoniades, Cameron Brown, Federica Rizzi, Anca Bucur, Elsa Pacella, Georgia Karanasiou, Daniela Cardinale, Carlo Cipolla, Elisabetta Munzone, Dimitrios Fotiadis, Giuseppe Curigliano, Gabriella Pravettoni

Affiliations

  • European Institute of Oncology, IRCCS, Milan, Italy.
  • Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.
  • Medical Oncology Department, Bank of Cyprus Oncology Centre, Nicosia, Cyprus.
  • Oncology-Pathology Dept. Karolinska Institutet - Cancer Center Karolinska (CCK), Solna, Sweden.
  • Medical Oncology Department, General Hospital of Lamia, Lamia, Greece.
  • Computation, Computational BioMedicine Laboratory (CBML), Foundation for Research and Technology-Hellas (FORTH), Heraklion, Greece.
  • Department of Electrical & Computer Engineering, Hellenic Mediterranean University (HMU), Chania, Greece.
  • Medical Oncology Department, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
  • 2nd Department of Surgery, Aretaieio University Hospital, National and Kapodistrian University of Athens, Athens, Greece.
  • 2nd Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.
  • Stremble Ventures LTD, Limassol, Cyprus.
  • IMS - Istituto di Management Sanitario, Bresso, Italy.
  • Philips Research Europe, Eindhoven, The Netherlands.
  • ESC, European Society of Cardiology, Sophia Antipolis, France.
  • Department of Materials Science and Engineering, UOI - University of Ioannina, Ioannina, Greece.

Abstract

BACKGROUND

Over 50% of newly diagnosed patients with breast cancer are aged ≥65 years. Due to age-related factors and the presence of comorbidities, these patients are particularly vulnerable to developing cardiac toxicity associated with cancer treatments, which may lead to suboptimal interventions and undertreatment, resulting in poorer health outcomes, quality of life (QoL) deterioration, and increased health care costs. Given the underrepresentation of older patients with breast cancer in clinical trials and the increasing recognition of the impact of psychosocial and behavioral factors on cardiovascular disease onset, broader and interdisciplinary studies are required to develop new and innovative best practices for this clinical population.

OBJECTIVE

Using an innovative eHealth approach combining the CARDIOCARE (An Interdisciplinary Approach for the Management of the Elderly Multimorbid Patient with Breast Cancer Therapy Induced Cardiac Toxicity-grant agreement 945175) mobile app and technologically advanced wearable devices (ie, the Garmin Venu SQ watch and Polar H10 sensor), the CARDIOCARE prospective study pursues a twofold aim: (1) testing the effectiveness of the CARDIOCARE mobile app to monitor and assess the intrinsic capacity and QoL of older patients with breast cancer and evaluating the CARDIOCARE eHealth interventions' effectiveness on these parameters and (2) developing a holistic, patient-centered risk prediction model specific for the detection of cardiotoxicity before it clinically emerges.

METHODS

This prospective and multicentric study involves 6 clinical and 5 technical partners across Europe. In total, 750 older patients with breast cancer (aged ≥60 years) are assigned to either the standard practice or enhanced monitoring group, with only patients in the latter receiving access to eHealth psychological, behavioral, and functional interventions implemented on the CARDIOCARE eHealtHeart app. Patients will be recruited in 6 clinical centers and will undergo clinical procedures to collect multimodal data, including clinical data, cardiac imaging, biochemical and psychological biomarkers and omics, intrinsic capacity, and QoL indicators measured at baseline (T0) and every 3 months up to 12 months (T5).

RESULTS

CARDIOCARE is a project funded by Horizon 2020, and enrollment started in May 2023. As of October 17, 2024, a total of 50% (375/750) of the target number of patients had been recruited.

CONCLUSIONS

The CARDIOCARE prospective study will contribute to developing new best practice guidelines for managing older patients with breast cancer and multimorbidity while preserving their intrinsic capacity and improving their QoL. Furthermore, the CARDIOCARE mobile app and the wearable devices will allow clinicians to identify trajectories across the cardiotoxicity disease continuum and thus intervene in a preventative way among patients at higher risk. Such a health care approach will also benefit the health care system, which currently spends almost 40% of its resources on patients aged >60 years, with long-term care and hospital admissions being the primary cost drivers.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06334445; https://clinicaltrials.gov/study/NCT06334445.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

DERR1-10.2196/63455.

MeSH

Breast Neoplasms, Neoplasms, Ecosystem, Aged, Breast, Cardiotoxicity, Wearable Electronic Devices, Mobile Applications, Therapeutics, Prospective Studies