Advertisement
Heart, Lung and Circulation

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

Published:April 22, 2021DOI:https://doi.org/10.1016/j.hlc.2021.03.271

      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).

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Heart, Lung and Circulation
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Jemal A.
        • Bray F.
        • Center M.M.
        • Ferlay J.
        • Ward E.
        • Forman D.
        Global cancer statistics.
        CA Cancer J Clin. 2011; 61: 69-90
        • Chang H.M.
        • Moudgil R.
        • Scarabelli T.
        • Okwuosa T.M.
        • Yeh E.T.H.
        Cardiovascular complications of cancer therapy: best practices in diagnosis, prevention, and management: part 1.
        J Am Coll Cardiol. 2017; 70: 2536-2551
        • Patnaik J.L.
        • Byers T.
        • DiGuiseppi C.
        • Dabelea D.
        • Denberg T.D.
        Cardiovascular disease competes with breast cancer as the leading cause of death for older females diagnosed with breast cancer: a retrospective cohort study.
        Breast Cancer Res. 2011; 13: R64
        • Lancellotti P.
        • Suter T.M.
        • López-Fernández T.
        • Galderisi M.
        • Lyon A.R.
        • Van der Meer P.
        • et al.
        Cardio-oncology services: rationale, organization, and implementation.
        Eur Heart J. 2019; 40: 1756-1763
        • Beatty A.L.
        • Fukuoka Y.
        • Whooley M.A.
        Using mobile technology for cardiac rehabilitation: a review and framework for development and evaluation.
        J Am Heart Assoc. 2013; 2: e000568
        • Bradford N.K.
        • Caffery L.J.
        • Smith A.C.
        Telehealth services in rural and remote Australia: a systematic review of models of care and factors influencing success and sustainability.
        Rural Remote Health. 2016; 16: 4268
        • Ibrahim E.M.
        • Al-Homaidh A.
        Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies.
        Med Oncol. 2011; 28: 753-765
        • Murphy A.C.
        • Meehan G.
        • Koshy A.N.
        • Kunniardy P.
        • Farouque O.
        • Yudi M.B.
        Efficacy of Smartphone-based secondary preventive strategies in coronary artery disease.
        Clin Med Insights Cardiol. 2020; 14 (1179546820927402)
        • Murphy A.C.
        • Koshy A.N.
        • Mousley J.
        • Meehan G.
        • Kunniardy P.
        • Clark D.
        • et al.
        Efficacy of mobile health cardiovascular risk-reduction strategies in cancer survivors.
        Eur J Prev Cardiol. 2020; (2047487320907548)
        • Yudi M.B.
        • Clark D.J.
        • Tsang D.
        • Jelinek M.
        • Kalten K.
        • Joshi S.
        • et al.
        SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes [SMART-REHAB Trial]: a randomized controlled trial protocol.
        BMC Cardiovasc Disord. 2016; 16: 170
        • Rasekaba T.
        • Lee A.L.
        • Naughton M.T.
        • Williams T.J.
        • Holland A.E.
        The six-minute walk test: a useful metric for the cardiopulmonary patient.
        Intern Med J. 2009; 39: 495-501
        • Schmidt K.
        • Vogt L.
        • Thiel C.
        • Jager E.
        • Banzer W.
        Validity of the six-minute walk test in cancer patients.
        Int J Sports Med. 2013; 34: 631-636
        • Coleman M.P.
        • Quaresma M.
        • Berrino F.
        • Lutz J.M.
        • De Angelis R.
        • Capocaccia R.
        • et al.
        Cancer survival in five continents: a worldwide population-based study (CONCORD).
        Lancet Oncol. 2008; 9: 730-756
        • Smith S.C.
        • Allen J.
        • Blair S.N.
        • Bonow R.O.
        • Brass L.M.
        • Fonarow G.C.
        • et al.
        AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update endorsed by the National Heart, Lung, and Blood Institute.
        J Am Coll Cardiol. 2006; 47: 2130-2139
        • Law W.
        • Johnson C.
        • Rushton M.
        • Dent S.
        The Framingham risk score underestimates the risk of cardiovascular events in the HER2-positive breast cancer population.
        Curr Oncol. 2017; 24: e348-e353
        • Foley M.P.
        • Hasson S.M.
        • Kendall E.
        Effects of a translational community-based multimodal exercise program on quality of life and the influence of start delay on physical function and quality of life in breast cancer survivors: a pilot study.
        Integr Cancer Ther. 2018; 17: 337-349

      Linked Article

      • Digital Technologies to Help Delivery of Cardio–Oncology Care
        Heart, Lung and CirculationVol. 30Issue 9
        • Preview
          Breast cancer is the second most common cancer in Australian women and is often perceived as the leading cause of mortality amongst women, ahead of cardiovascular disease [1,2]. However, the most recent Australian Bureau of Statistics (ABS) data from 2019 demonstrates that ischaemic heart disease, which is ranked second in overall mortality, accounted for 7,422 deaths and an age-standardised death rate of 37.7. Breast cancer was ranked as the sixth leading cause of death in Australian women in 2019, accounting for 3,230 deaths and an age-standardised death rate of 20 [1].
        • Full-Text
        • PDF