CARDIOCARE Prospective Clinical Study (CARDIOCARE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Control group; Behavioral: Intervention group

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.

• Study Type: Observational
• Enrollment (Estimated): 736

Contacts and Locations

• Study Contact: Name: Gabriella Pravettoni; Phone Number: +39 02 57489.731; Email: gabriella.pravettoni@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Gabriella Pravettoni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The prospective clinical study will enroll a total of 750 breast cancer patients over 12 months.

Description

Inclusion Criteria:

1. Women ≥ 60 years with a diagnosis of early/locoregional breast cancer who will undergo neoadju-vant and/or adjuvant treatment with regimens including anthracyclines and/or taxanes.
2. Women ≥ 60 years with a diagnosis of HER2-positive locoregional breast cancer who will undergo neoadjuvant and/or adjuvant treatment with anti-HER2 therapy (trastuzumab or trastuzumab and pertuzumab).
3. Women ≥ 60 years with a diagnosis of early/locoregional breast cancer who will undergo neoadju-vant 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 pertuzumab +/- chemotherapy).
5. Women with age ≥ 60 years before starting the aforementioned treatment for breast cancer.
6. Women eligible ≥ 60 years who will undergo first-line therapy in the metastatic setting with any type of treatment (chemotherapy, immunotherapy, biological agents).
7. Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures
8. Written informed consent.
9. Participant affiliated to a social security system.
10. Life expectancy of at least 12 months.

Exclusion Criteria:

1. Age < 60 years.
2. Diagnosed severe psychiatric or neurological disorders that might impair the ability to give informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Wearables/sensors and ePsycHeart App	Behavioral: Control group; Wearables/sensors and ePsycHeart App
Intervention group; Wearables/sensors and ePsycHeart App and eHealtHeart	Behavioral: Intervention group; Wearables/sensors and ePsycHeart App and eHealtHeart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-patient assessment of major adverse cardiac events (MACEs)	Angina pectoris;; Acute myocardial infarction;; Major ventricular arrhythmias;; Pacemaker implantation;; Acute heart failure (New York Heart Association (NYHA) class 4);; Acute ischemic brain disease with neurological persistence evidence;; Severe hypertension requiring treatment with Angiotensin-converting enzyme (ACE) and or beta blockers.	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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Gabriella Pravettoni, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IEO 1874

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No