An interdisciplinary ecosystem for the psychosocial and behavioural management of Cardiotoxicity in elderly breast cancer patient: a prospective clinical study (Preprint)
Authors: Sacco Gaia Giulia Angela , Mazzocco Ketti , Constantinidou Anastasia , Papakonstantinou Andri , Mauri Davide , Kalliatakis Grigorios , Tsiknakis Manolis , Ribnikar Domen , Tsekoura Dorothea , Aidarinis Valantis , Kalliopi Keramida , Panagiota Oikonomopoulou , Antoniades Athos , Rizzi Federica , Karanasiou Georgia , Bucur Anca , Pacella Elsa , Cardinale Daniela , Cipolla Carlo , Munzone Elisabetta , Fotiadis Dimitris , Curigliano Giuseppe , Pravettoni Gabriella 
Published: June 2024

BACKGROUND

Over 50% of newly diagnosed breast cancer patients are 65+ years old. 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 healthcare costs. Given the underrepresentation of elderly breast cancer patients in clinical trials and the increasing recognition of psycho-social and behavioural factors’ impact on cardiovascular (CV) 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 (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 (i.e., the Garmin Venu SQ watch and the Polar h10), the CARDIOCARE prospective study pursues a twofold aim: 1) testing the effectiveness of the CARDIOCARE mobile App to monitor and assess elderly breast cancer patients’ intrinsic capacity and QoL and evaluating CARDIOCARE eHealth interventions effectiveness on these parameters 2) developing a holistic, patient-centred risk prediction model, specific for the detection of cardiotoxicity before it clinically emerges.

METHODS

The study is prospective and multicentric and involves six clinical and five technical partners across Europe. Seven hundred fifty elderly breast cancer patients (≥ 60years old) are randomised into either the intervention group or the control arm, with only patients in the former receiving access to eHealth psychological, behavioural, and functional interventions implemented on the CARDIOCARE eHealtHeart App. Patients will be recruited in the six clinical centres and will undergo clinical procedures to collect multi-modal data including clinical data, cardiac imaging, biochemical and psychological biomarkers and omics, intrinsic capacity, and QoL indicators, measured at baseline (T0) and every three months, up to 12 months (T5).

RESULTS

CARDIOCARE is a project funded by Horizon 2020 and enrollment (WP4) started in May 2023. Recruitment and first data analysis are currently underway.

CONCLUSIONS

The CARDIOCARE prospective study will contribute to developing new best practice guidelines for managing elderly multimorbid breast cancer patients 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 on higher-risk patients. Such a healthcare approach will also benefit the healthcare system, which currently spends almost 40% of its resources on patients over 60, with long-term care and hospital admissions being the primary cost drivers.

CLINICALTRIAL

NCT06334445