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This is a prospective observational study to refine and validate risk stratification algorithms aimed at identifying elderly patients at higher risk of developing cardiotoxicity (us-ing risk factors and potential blood and stool biomarkers) and at assessing whether integrated patient-oriented behavioral and psychological interventions can mitigate, prevent or delay the onset of cardiotoxicity from chemotherapy.
This is a prospective observational study for women with diagnosis of Breast Cancer (BC) who will undergo neoadjuvant and/or adjuvant treatment:
The study primary objective is to evaluate the onset of cardiotoxicity, where: subclinical car-diotoxicity is defined as preserved Left Ventricular Ejection Fraction (LVEF).
All patients will receive, in addition to standard of care, supportive care. Patients in the control and in the intervention group will receive wearable and will be invited to complete the mobile ePsycHeart evaluation. ePsycHeart will assess patients' intrinsic capacity indicators that may be associated with including
In addition, patients in the intervention group will receive the eHealtHeart: Behavioral and psychological interventions will be delivered to the intervention arm via the eHealtHeart mobile application to mitigate potential risk factors associated with cardiotoxicity and deterioration of QoL. eHealtHeart interventions will target patients and care givers aiming at improving patients' intrinsic capacity including psychological inter-ventions (e.g. emotional, dispositional states, biofeedback self-regulation, best possible self), cognitive stim-ulation (e.g. cognitive restructuring plus card games to improve memory and executive functions), sensory screening, physical activity and performance exercises, vision and hearing suggestions, dietary guidance on nutrition, guidance to improve management of urinary inconti-nence (e.g. alerts, self-monitoring) and falls together with providing education and support to caregivers. At month 6 the patient will have to return the wearables used for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Wearables/sensors and ePsycHeart App |
| |
| Intervention group | Wearables/sensors and ePsycHeart App and eHealtHeart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Behavioral | Wearables/sensors and ePsycHeart App |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the onset of cardiotoxicity | Subclinical cardiotoxicity is defined as preserved Left Ventricular Ejection Fraction (LVEF) with >15% reduction in Global Longitudinal Strain (GLS) relative to baseline and/or new rise in cardiac Troponin I or Natriuretic peptides levels in plasma. Clinical cardiotoxicity is defined as the reduction of LVEF by ≥ 10% from baseline to a value below 50%, incurred at any timepoint during study Follow Up (FU) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-patient assessment of major adverse cardiac events (MACEs) |
|
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Inclusion Criteria:
Exclusion Criteria:
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The prospective clinical study will enroll a total of 750 breast cancer patients over 12 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriella Pravettoni | Contact | +39 02 57489.731 | gabriella.pravettoni@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Gabriella Pravettoni | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40810441 | Derived | Sacco GGA, Mazzocco K, Constantinidou A, Papakonstantinou A, Mauri D, Kalliatakis G, Tsiknakis M, Ribnikar D, Tsekoura D, Aidarinis V, Keramida K, Oikonomopoulos P, Antoniades A, Brown C, Rizzi F, Bucur A, Pacella E, Karanasiou G, Cardinale D, Cipolla C, Munzone E, Fotiadis D, Curigliano G, Pravettoni G. An Interdisciplinary Ecosystem for the Prevention of Cardiotoxicity in Older Patients With Breast Cancer: Protocol for a Prospective and Multicentric Study. JMIR Res Protoc. 2025 Aug 14;14:e63455. doi: 10.2196/63455. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Whole blood and plasma, stool
| Intervention group |
| Behavioral |
Wearables/sensors and ePsycHeart App and eHealtHeart |
|
| 12 months |
| Intra-patient assessment of plasma Troponin I | Intra-patient assessment of plasma Troponin I during follow up and association/agreement with LVEF | 12 months |
| Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation | Intra-patient assessment of plasma Brain natriuretic peptide (BNP) elevation | 12 months |
| Percentage in the two arm of hospital admission | Hospital admissions from cardiovascular causes or falls in order to evaluate the percentage in the two arms | 12 months |
| Number of Cardiovascular death in the two arms | Number of Cardiovascular death in the two arms | 12 months |
| Number of Non-cardiovascular death in the two arms | Number of Non-cardiovascular death in the two arms | 12 months |
| Evaluation of Health Related Quality of Life in the two arms | Evaluation of Health Related Quality of Life in the two arms assessed by EORTC QLQ-BR23, validated breast cancer Patient Re-ported Outcome Measure (PROM) | 12 months |
| Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-adjusted life-years (QALYs) in the two arms | Cost-effectiveness of provided healthcare pathways determined by costs combined with quality-ad-justed life-years (QALYs). Costs will consider healthcare provided, numbers of admission and days spent in hospital and patient costs for out-of-pocket expenses associated with their condition (i.e., travel expenses (of both patient and caregiver), over-the-counter medicines and supplements, com-plementary therapies not supported by Healthcare system, home help, and time away from work). | 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008722 | Methods |