Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334445
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-21
Brief Title:
CARDIOCARE Prospective Clinical Study
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
CARDIOCARE Prospective Clinical Study An Interdisciplinary Approach for the Management of the Elderly Multimorbid Patient With Breast Cancer Therapy Induced Cardiac Toxicity
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARDIOCARE
Brief 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 andor adjuvant treatment
1 Women 60 years with a diagnosis of HER2-positive earlylocoregional breast cancer with anti-HER2 therapy trastuzumab or trastuzumab and pertuzumab
2 Women 60 years with a diagnosis of earlylocoregional breast cancer who will un-dergo neoadjuvant andor adjuvant treatment with regimens including anthracy-clines andor taxanes
3 Women 60 years with a diagnosis of earlylocoregional breast cancer who will un-dergo neoadjuvant andor adjuvant treatment with endocrine therapies - CDK 46 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 nutritionalenergy 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 eg emotional dispositional states biofeedback self-regulation best possible self cognitive stim-ulation eg 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 eg 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
1 Women 60 years with a diagnosis of HER2-positive earlylocoregional breast cancer with anti-HER2 therapy trastuzumab or trastuzumab and pertuzumab
2 Women 60 years with a diagnosis of earlylocoregional breast cancer who will un-dergo neoadjuvant andor adjuvant treatment with regimens including anthracy-clines andor taxanes
3 Women 60 years with a diagnosis of earlylocoregional breast cancer who will un-dergo neoadjuvant andor adjuvant treatment with endocrine therapies - CDK 46 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 nutritionalenergy 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 eg emotional dispositional states biofeedback self-regulation best possible self cognitive stim-ulation eg 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None