Multicenter Cardiac Decision Impact Study in People With Breast Cancer (CarDI)
ARTILLERY-CarDI, Early Detection of Non-communicable Disease Risk in People With Breast Cancer: Multicenter Cardiac Decision Impact Study
Background:
Breast cancer is the most common cancer in women, and advances in early detection and treatment have led to steadily improved survival rates. Today, nearly 80% of breast cancer survivors are over 50 years of age. With longer survival, comes a greater burden of chronic disease, particularly cardiovascular disease (CVD), which is more common in breast cancer survivors than in the general population. This elevated risk is driven by treatment-related effects, such as chemotherapy- and radiotherapy-induced cardiotoxicity, metabolic changes including (therapy-associated) weight gain, and shared lifestyle risk factors such as obesity and physical inactivity. In routine clinical care, approximately 65% of breast cancer patients undergo local radiotherapy (RT) and will receive a planning computed tomography (CT) scan. These scans, while intended for RT planning, also capture valuable information on coronary artery calcifications (CAC), a well-established marker risk factor of CVD risk.
The ARTILLERY-CarDI study is a multinational decision impact trial which will evaluate calculating CAC-based CVD risk (Agatston score) and communicating personalized, risk-based management recommendations to breast cancer patients.
Aims and outcomes:
In this study, CVD risk is estimated based on the manual CAC (Agatston) score using RT planning CT scans and a corresponding CVD risk-based recommendation is provided to breast cancer patients. The main aim of this study is to disclose this estimated CVD risk to treating physicians and patients and investigate how this risk affects:
- breast cancer treatment (retrospectively) and cardiovascular care (i.e., no further action, recommendation for lifestyle changes, referral to a cardiologist or general practitioner (GP)), and
- patients' satisfaction with their decision to receive their estimated CVD risk and the corresponding CVD risk-based management.
Secondary aims are to evaluate whether the knowledge of estimated CVD risk and corresponding CVD-risk based management impacts patients' decisions regarding their lifestyle and habits, decisional conflict regarding lifestyle decision changes, patient reported outcomes (PROs) and changes in CVD risk factors and CVD treatment.
Methods:
ARTILLERY-CarDI is a multinational, multicenter, prospective decision impact trial, designed as a within-subject trial in which participants serve as their own controls. A total of 1,000 patients with breast cancer will be enrolled over 1.5 years across five centers in four countries (the Netherlands with two participating centers, Germany, Portugal, and Denmark). Each participant will be followed for six months.
The intervention is the CVD risk estimation based on the CAC (Agatston) score using RT planning CT scans, and the subsequent disclosure of the estimated CVD risk and corresponding CVD risk-based management to the patient using the ARTILLERY manual. The CAC (Agatston) score will be measured after the RT planning CT scan is made, which is usually one or two weeks before the start of RT. The Agatston score is a validated method for CVD risk assessment using the amount of CAC. CVD risk is categorized in 5 groups with an Agatston score of 0, 1-10, 11-100, 101-400, and >400. In the current trial, endpoints will be analyzed according to low, moderate, and high-CVD-risk groups corresponding to score ranges 0-10, 11-100, and >100, respectively.
Following a study-specific manual , eligible patients will be referred to a cardiologist or GP if a previously unknown moderate to high risk of CVD according to CAC is determined (Agatston score >10). Thereafter, these patients will be treated accordingly as part of standard care. We expect that the timely measurement of estimated CVD risk by the amount of CAC on a planning CT scan and the disclosure of CVD risk-based management is beneficial for patients. The CVD risk measurement will lead to the identification of breast cancer patients with a previously unknown moderate to high estimated CVD risk and possibly undertreated cardiac conditions. The disclosure of CVD risk-based management is intended to empower patients to manage their own physical health and well-being. Also, we expect that the CVD risk measurement and CVD risk-based management will create more awareness among doctors and citizens about CVD risk in breast cancer patients. A potential side-effect of CAC- based CVD risk measurement and disclosure of CVD risk-based management is that, some patients may experience increased anxiety leading to dissatisfaction or regret about their decision to participate. The Satisfaction with Decision (SWD) questionnaire will be used to measure patients' satisfaction about their decision as one of the primary outcomes and the level of anxiety by the Hospital Anxiety and Depression Scale, at baseline, at one month and at six months after the intervention.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Verkooijen
- Número de teléfono: +31 (0) 88 755 6689
- Correo electrónico: cardi@umcutrecht.nl
Ubicaciones de estudio
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München, Alemania
- Aún no reclutando
- LMU University Hospital
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Contacto:
- Nadia Harbeck
- Número de teléfono: +4989440077581
- Correo electrónico: cardi@umcutrecht.nl
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Copenhagen, Dinamarca
- Aún no reclutando
- RegionH
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Contacto:
- Maja Maraldo
- Número de teléfono: +45 56513101
- Correo electrónico: cardi@umcutrecht.nl
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Amsterdam, Países Bajos
- Aún no reclutando
- Amsterdam University Medical Center
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Contacto:
- Desiree van den Bongard
- Número de teléfono: +31611467542
- Correo electrónico: cardi@umcutrecht.nl
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Utrecht, Países Bajos
- Reclutamiento
- St. Antonius Hospital
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Contacto:
- Annemiek Doeksen
- Correo electrónico: cardi@umcutrecht.nl
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Lisbon, Portugal
- Aún no reclutando
- Champalimaud Foundation
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Contacto:
- Eva Batista
- Número de teléfono: +351967220171
- Correo electrónico: cardi@umcutrecht.nl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- diagnosed with breast cancer or ductal carcinoma in situ
- Planned for radiotherapy
- From 35 years of age onwards
Exclusion Criteria:
- Pregnancy
- Breastfeeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Estimating CVD-risk by measuring coronary artery calcifications (Agatston score) on routine CT scans
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The cardiovascular disease (CVD) risk will be estimated based on the amount of coronary artery calcifications (Agatston score) using routine radiotherapy planning CT scans.
Subsequently, this estimated CVD risk and the corresponding disease management will be disclosed to the patient.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Changes in breast cancer treatment decisions (retrospective) and CVD risk- based management (cardiovascular care), and patients' satisfaction with their decision to receive personalized CVD-risk estimation and CVD risk-based management.
Periodo de tiempo: From enrollment to 6 months after the personalized CVD-risk (based on coronary artery calcifications, Agatston score) disclosure.
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From enrollment to 6 months after the personalized CVD-risk (based on coronary artery calcifications, Agatston score) disclosure.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NL010708
- 101080983 (Otro número de subvención/financiamiento: Horizon Europe, European Commission)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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