An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study
BackgroundOver 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 s...
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JMIR Publications
2025-08-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Gaia Giulia Angela Sacco |
| collection | DOAJ |
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BackgroundOver 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.
ObjectiveUsing 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.
MethodsThis 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).
ResultsCARDIOCARE 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.
ConclusionsThe 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 RegistrationClinicalTrials.gov NCT06334445; https://clinicaltrials.gov/study/NCT06334445
International Registered Report Identifier (IRRID)DERR1-10.2196/63455 |
| format | Article |
| id | doaj-art-c6f25c9d9a36450fa51e4ca8e99f44cc |
| institution | Kabale University |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | JMIR Publications |
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| series | JMIR Research Protocols |
| spelling | doaj-art-c6f25c9d9a36450fa51e4ca8e99f44cc2025-08-20T03:36:54ZengJMIR PublicationsJMIR Research Protocols1929-07482025-08-0114e6345510.2196/63455An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric StudyGaia Giulia Angela Saccohttps://orcid.org/0000-0002-5450-5317Ketti Mazzoccohttps://orcid.org/0000-0003-1382-6779Anastasia Constantinidouhttps://orcid.org/0000-0001-5316-7574Andri Papakonstantinouhttps://orcid.org/0000-0002-4232-4658Davide Maurihttps://orcid.org/0000-0002-8501-5986Grigorios Kalliatakishttps://orcid.org/0000-0002-2194-7709Manolis Tsiknakishttps://orcid.org/0000-0001-8454-1450Domen Ribnikarhttps://orcid.org/0000-0001-5146-4524Dorothea Tsekourahttps://orcid.org/0000-0002-9896-964XValantis Aidarinishttps://orcid.org/0009-0004-7405-3217Kalliopi Keramidahttps://orcid.org/0000-0002-9533-6951Panagiotis Oikonomopouloshttps://orcid.org/0000-0002-6417-8241Athos Antoniadeshttps://orcid.org/0000-0002-5789-5103Cameron Brownhttps://orcid.org/0000-0002-6736-0620Federica Rizzihttps://orcid.org/0000-0002-4606-6553Anca Bucurhttps://orcid.org/0000-0002-1940-5652Elsa Pacellahttps://orcid.org/0009-0007-1141-8583Georgia Karanasiouhttps://orcid.org/0000-0001-9478-0375Daniela Cardinalehttps://orcid.org/0000-0002-4038-8033Carlo Cipollahttps://orcid.org/0000-0003-4168-1474Elisabetta Munzonehttps://orcid.org/0000-0003-3371-3878Dimitrios Fotiadishttps://orcid.org/0000-0002-7362-5082Giuseppe Curiglianohttps://orcid.org/0000-0003-1781-2518Gabriella Pravettonihttps://orcid.org/0000-0002-4843-4663 BackgroundOver 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. ObjectiveUsing 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. MethodsThis 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). ResultsCARDIOCARE 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. ConclusionsThe 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 RegistrationClinicalTrials.gov NCT06334445; https://clinicaltrials.gov/study/NCT06334445 International Registered Report Identifier (IRRID)DERR1-10.2196/63455https://www.researchprotocols.org/2025/1/e63455 |
| spellingShingle | 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 An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study JMIR Research Protocols |
| title | An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study |
| title_full | An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study |
| title_fullStr | An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study |
| title_full_unstemmed | An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study |
| title_short | An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study |
| title_sort | interdisciplinary ecosystem for the prevention of cardiotoxicity in older patients with breast cancer protocol for a prospective and multicentric study |
| url | https://www.researchprotocols.org/2025/1/e63455 |
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