NCT06334445

CARDIOCARE Prospective Clinical Study

CARDIOCARE Prospective Clinical Study An Interdisciplinary Approach for the Management of the Elderly Multimorbid Patient With Breast Cancer Therapy Induced Cardiac Toxicity

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 736 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective observational study for women with diagnosis of Breast Cancer (BC) who will undergo neoadjuvant and/or adjuvant treatment: 1. Women ≥ 60 years with a diagnosis of HER2-positive early/locoregional breast cancer with anti-HER2 therapy (trastuzumab or trastuzumab and pertuzumab) 2. Women ≥ 60 years with a diagnosis of early/locoregional breast cancer who will un-dergo neoadjuvant and/or adjuvant treatment with regimens including anthracy-clines and/or taxanes 3. Women ≥60 years with a diagnosis of early/locoregional breast cancer who will un-dergo neoadjuvant and/or adjuvant treatment with endocrine therapies +/- CDK 4/6 inhibitors 4. Women ≥ 60 years with HER2-positive metastatic breast cancer who will undergo first-line therapy with anti-HER2 therapy (trastuzumab or trastuzumab and per-tuzumab +/- chemotherapy). 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 1. psycho cognitive states (psychological and emotional states, QoL, cognitive function and memory, perceptions of aging, environmental and social factors), 2. mobility and locomotion (distance, balance, gait speed), and 3. vitality (exercise, electrocardiogram (ECG), Heart Rate Variability (HRV), grip strength, nutritional/energy state, sleep, fatigue), will be performed by means of sensors, wearables, electronic devices and validated patient reported outcome- and experience measures. 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Control group	Wearables/sensors and ePsycHeart App
BEHAVIORAL	Intervention group	Wearables/sensors and ePsycHeart App and eHealtHeart

Timeline

• Start date: 2023-09-14
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

1 site across 1 country: Italy