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SMARTphone Based Cardiovascular Risk Reduction in BREAST Cancer Patients (SMART-BREAST): A Randomised Controlled Trial Protocol - 04/08/21

Doi : 10.1016/j.hlc.2021.03.271 
Alexandra C. Murphy, MBBS a, b, c, d, Omar Farouque, MBBS, PhD a, b, Belinda Yeo, MD c, Ron Dick, MBBS d, Anoop N. Koshy, MBBS a, b, Laura Roccisano, RN a, Christopher Reid, BA, MSc, PhD e, Jaishankar Raman, MBBS a, b, f, g, Leighton Kearney, MBBS, PhD a, b, Matias B. Yudi, MBBS, PhD a, b, d,
a Department of Cardiology, Austin Health, Melbourne, Vic, Australia 
b Department of Medicine, University of Melbourne, Vic, Australia 
c Department of Oncology, The Olivia Newton John Cancer and Wellness Centre, Melbourne, Vic, Australia 
d Department of Cardiology, Epworth HealthCare, Melbourne, Vic, Australia 
e School of Public Health, Curtin University, Perth, WA, Australia 
f Department of Medicine, Deakin University, Geelong, Vic, Australia 
g Department of Medicine, The University of Illinois, Champaign, IL, USA 

Corresponding author at: Department of Cardiology, Austin Hospital, 145 Studley Road, Heidelberg 3084, Vic, AustraliaDepartment of CardiologyAustin Hospital145 Studley RoadHeidelbergVic3084Australia

Abstract

Introduction

Breast cancer survivors are at greater risk for cardiovascular-related mortality compared to women without breast cancer. Accordingly, attention to reducing the risk of cardiovascular disease must be a priority in the long-term management of these patients. With the exponential rise in cancer survivors, there is a need for innovative cardio-oncology programs. This paper describes the study design of a randomised controlled trial assessing the effectiveness of a smartphone-based cardiovascular risk reduction program in improving physical activity and cardiovascular health in patients undergoing treatment for breast cancer.

Methods and Analysis

The aim of this study is to assess the efficacy and usability of a smartphone-based model of care for exercise promotion, cardiovascular risk reduction and community engagement in women undergoing treatment for breast cancer. This will be achieved by testing our personalised smartphone application “BreastMate”, as an adjunct to standard care in a single-blinded, parallel, randomised controlled trial. The primary outcome of the trial is change in exercise capacity, as measured by the 6-minute walk test distance at 12 months compared to baseline. Secondary endpoints include improvements in cardiovascular risk factor status and quality of life, received dose intensity of chemotherapy and major adverse cardiovascular events.

Ethics

Multicentre ethical approval has been granted by the Austin Hospital (HREC/47081/Austin/2018).

Dissemination of Results

The analysed results will be published in a peer reviewed journal on completion of the clinical trial.

Registration Details

SMART-BREAST has been prospectively registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR12620000007932).

El texto completo de este artículo está disponible en PDF.

Keywords : Cardiovascular risk reduction, Breast cancer, Digital health, Smartphone, Cardio-oncology, Randomised controlled trial protocol


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© 2021  Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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Vol 30 - N° 9

P. 1314-1319 - septembre 2021 Regresar al número
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