Randomized Controlled Trial of a Smartphone-Based Intervention to Enhance 6-Minute Walk Distance During Breast Cancer Treatment: The SMART-BREAST Trial

HomeCirculationVol. 147, No. 7Randomized Controlled Trial of a Smartphone-Based Intervention to Enhance 6-Minute Walk Distance During Breast Cancer Treatment: The SMART-BREAST Trial Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBRandomized Controlled Trial of a Smartphone-Based Intervention to Enhance 6-Minute Walk Distance During Breast Cancer Treatment: The SMART-BREAST Trial Alexandra C. Murphy, Omar Farouque, Anoop N. Koshy, Belinda Yeo, Ron Dick, Voltaire Nadurata, Laura Roccisano, Christopher Reid and Matias B. Yudi Alexandra C. MurphyAlexandra C. Murphy Correspondence to: Alexandra C. Murphy, MBBS, BMedSci, Department of Cardiology, Austin Hospital, 145 Studley Rd, Heidelberg 3084, Victoria, Australia. Email E-mail Address: [email protected] https://orcid.org/0000-0002-4248-7537 Austin Health, Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). The University of Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). Olivia Newton-John Cancer Wellness & Research Centre, Melbourne, Australia (A.C.M., B.Y.). Epworth Richmond, Melbourne, Australia (A.C.M., R.D., M.B.Y.). Bendigo Health, Australia (A.C.M., V.N., M.B.Y.). Search for more papers by this author , Omar FarouqueOmar Farouque https://orcid.org/0000-0003-2821-1451 Austin Health, Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). The University of Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). Search for more papers by this author , Anoop N. KoshyAnoop N. Koshy https://orcid.org/0000-0002-8741-8631 Austin Health, Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). The University of Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). Search for more papers by this author , Belinda YeoBelinda Yeo Olivia Newton-John Cancer Wellness & Research Centre, Melbourne, Australia (A.C.M., B.Y.). Epworth Richmond, Melbourne, Australia (A.C.M., R.D., M.B.Y.). Search for more papers by this author , Ron DickRon Dick https://orcid.org/0000-0003-1447-8198 Search for more papers by this author , Voltaire NadurataVoltaire Nadurata Epworth Richmond, Melbourne, Australia (A.C.M., R.D., M.B.Y.). Bendigo Health, Australia (A.C.M., V.N., M.B.Y.). Search for more papers by this author , Laura RoccisanoLaura Roccisano https://orcid.org/0000-0003-3206-0166 Austin Health, Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). The University of Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). Search for more papers by this author , Christopher ReidChristopher Reid https://orcid.org/0000-0001-9173-3944 Curtin University, Perth, Australia (C.R). Search for more papers by this author and Matias B. YudiMatias B. Yudi Austin Health, Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). The University of Melbourne, Australia (A.C.M., O.F., A.N.K., L.R., M.B.Y.). Epworth Richmond, Melbourne, Australia (A.C.M., R.D., M.B.Y.). Bendigo Health, Australia (A.C.M., V.N., M.B.Y.). Search for more papers by this author Originally published7 Nov 2022https://doi.org/10.1161/CIRCULATIONAHA.122.062946Circulation. 2023;147:614–616This article is commented on by the following:Does Physical Activity During Cancer Treatment Preserve Exercise Capacity?Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: November 7, 2022: Ahead of Print Breast cancer is the most common cancer among women, and accounts for one-fourth of cancer diagnoses worldwide. Because of advancements in modern cancer therapy, we are now seeing higher rates of cure and the conversion of a terminal illness into a chronic disease.1 Accordingly, cardiovascular disease has become the leading cause of death in survivors of breast cancer,2 and attention to reducing the risk of cardiovascular disease should be a priority in their long-term management. Although cardio-oncology services have been successful in improving cardiovascular outcomes internationally, the substantial resources required limit their reach and sustainability. Easily disseminated and cost-effective programs may overcome these boundaries. In this respect, smartphone technology has the potential to revolutionize the cardiovascular care of patients with cancer. The SMART-BREAST (Smartphone Based Cardiovascular Risk Reduction in Breast Cancer Patients) trial evaluates the effect of a smartphone-based program on 6-minute walk test (6MWT) distance and cardiac risk factor modification in patients with breast cancer.Editorial, see p 546Patients with breast cancer were randomly assigned to standard care (SC), with or without the adjunctive smartphone (SP) application, BreastMate. The primary end point was between-group differences in the change in 6MWT distance at 12 months compared with baseline by using a linear mixed-effects model. A minimally important distance of 42 m was determined3 with a sample size calculation of 80 participants. Secondary end points included changes in cardiovascular risk factors and psychological well-being. BreastMate has been described previously in detail.4 In brief, BreastMate is a multifaceted intervention with emphasis on physical activity. It accesses the built-in pedometer in the smartphone for accurate, real-time reporting of step count, and incorporates all core aspects of cardiovascular risk reduction. Regardless of the treatment arm, all patients received standard-of-care treatment for their breast cancer. The Austin Health human research ethics committee granted approval for the trial (HREC/47081/Austin/2018). It conforms to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement, and was prospectively registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR12620000007932). All patients gave informed consent. The data that support the findings of this study are available from the corresponding author on reasonable request.A total of 103 patients (mean age, 60±12 years) underwent randomization, 23 of whom were lost to follow-up. Of the 80 patients who completed follow-up, 41 were in the SP group, and 39 were in the SC group. Patients in the SP group had a slightly higher body mass index (29.2±4 versus 26.8±6; P=0.03) at baseline. All other baseline demographics and cancer treatment modalities were comparable. For patients who completed follow-up, the 6MWT distance increased from a median 466 m (interquartile range [IQR], 431–522) to 528 m (IQR, 480–576; P<0.001) in the SP group and from 465 m (IQR, 400–501) to 490 m (IQR, 440–510) in the SC group (P=0.047). Compared with the SC group, the SP group demonstrated a significantly greater increase in 6MWT distance (median Δ46 m [IQR, 28–63] versus Δ8 m (IQR, –10 to 35; P<0.001; Table). Analysisperformed using a linear mixed-effects model to include the baseline values of subjects with only one measurement demonstrated consistent findings (β coefficient, 43.3 [95% CI, 14.4–72.3]; P=0.003). No significant differences in the secondary cardiovascular outcome measures or the SF-36 (36-item short-form) questionnaire at 12 months were noted when comparing the SP and SC groups (Table).Table. Clinical OutcomesSmartphone(n=41)Standard care(n=39)P value*6MWT distance at baseline, m, median (IQR)467 (430 to 526)469 (420 to 505)0.386MWT distance at 12 months, m, median (IQR)528 (480 to 576)490 (440 to 510)<0.001∆6MWT, m, median (IQR)46 (28 to 63)8 (–10 to 35)0.003∆Body mass index, kg/m2, median (IQR)–0.4 (–1.4 to 0.4)0 (–0.4 to 0.6)0.11∆Waist circumference, cm, median (IQR)–1.0 (–4.0 to 0)0 (–1.5 to 1.0)0.42∆Cholesterol panel, mg/dL, median (IQR) Total cholesterol–0.20 (–0.7 to 0.10)0 (–0.4 to 0.40)0.76 High-density lipoprotein cholesterol0 (–0.14 to 0.20)0.10 (–0.2 to 0.2)0.97 Low-density lipoprotein cholesterol–0.20 (–0.5 to 0.2)0.05 (–0.6 to 0.30)0.43∆Glucose metrics, median (IQR) Fasting glucose, mg/dL0.30 (–0.5 to 1.0)– 0.10 (–0.8 to 0.4)0.29 Hemoglobin A1C, %–0.10 (–0.30 to 0.10)0 (–0.1 to 0.3)0.93∆Blood pressure, mm Hg, median (IQR) Systolic blood pressure–5.0 (–10 to 0)0 (–10 to 7)0.33 Diastolic blood pressure0 (–5 to 5)0 (–5 to 10)0.77∆SF-36 questionnaire, median (IQR) Physical functioning0 (–5.0 to 10.0)0.0 (–5 to 15)0.97 Role limitations: functional0 (0 to 25)0 (0–25)0.89 Role limitations: emotional0 (0 to 33)0 (0 to 33)0.85 Vitality15 (0 to 25)2.5 (–10 to 15)0.33 Emotional well-being31 (15 to 47)22 (11 to 33)0.76 Social function25 (0 to 50)12.5 (0 to 37.5)0.81 Pain10 (0 to 25)1.25 (–12.5 to 22.5)0.09 General health0 (–5 to 10)0 (–10 to 10)0.53∆ represents the change from baseline to 12 months for patients with paired values. 6MWT indicates 6-minute walk test; IQR, interquartile range; and SF-36, 36-item short-form.* P values represent linear mixed-effects modeling, except for baseline and 12-month 6MWT comparison.It has been well established that cardiac risk factors contribute to total mortality and breast cancer–specific mortality.2 Of all lifestyle interventions, physical activity has the most robust effect on outcomes, with observational data suggesting a potential survival benefit in both cancer and cardiovascular disease.5 Despite this, most cancer survivors experience a significant decline in exercise levels after diagnosis, in particular, when undergoing treatment. Explanations for this include fatigue, symptoms associated with cancer and the treatment, lack of confidence regarding the safety of exercise, and the lack of access to individual recommendations or cancer-specific exercise programs.5 This was evident in our study, as patients in the SC group did not achieve the predefined minimally clinically significant improvement of 42 m in 6MWT distance during the 12 months of observation. In keeping with our primary hypothesis, patients enrolled in the BreastMate program demonstrated a relative 5-fold improvement in 6MWT distance compared with the SC arm. The clinical implication of this cannot be ignored, as exercise, although not an alternative to anticancer treatment, should be seen as a critical synergistic therapy. It is conceivable that a model of care that increases physical activity through constant engagement using a smartphone application may lead to improved patient outcomes.As is a risk of small trials, the imbalance in randomized groups at baseline raises the plausibility that differences that occurred reflect regression to the mean rather than intervention effect. This underlines the importance of further research with larger populations, stratified by cancer therapy exposure with longer follow-up, that are powered to assess for changes in cardiovascular risk factors and events. Government-mandated border closures, restricted access to the hospital system, and quarantine requirements resulted in a higher-than-expected dropout rate. Finally, although there have been exponential growth and availability of smartphone technology over the past decade, digital interventions may exclude vulnerable subpopulations without access to this technology. However, we have demonstrated the role of an easily disseminated and broad-reaching program that improved the 6MWT distance at 12 months. This model of care overcomes resource and geographic barriers, and has the potential to have a significant effect on the cardiovascular health and well-being of patients with breast cancer.Article InformationSources of FundingThe SMART-BREAST (Smartphone-Based Cardiovascular Risk Reduction in Breast Cancer Patients) trial was funded by the Epworth Medical Foundation Meadownick grant, which did not have any role in the design of the study protocol or conduct of the trial. Dr Murphy is supported by the Cardiac Society of Australia and New Zealand PhD Scholarship and the joint National Heart Foundation of Australia and National Health and Medical Research Council PhD Scholarship. Dr Koshy is supported by a postdoctoral scholarship from the National Heart Foundation of Australia.Nonstandard Abbreviations and Acronyms6MWT6-minute walk testSCStandard careSPSmartphoneDisclosures None.FootnotesThis article is part of the Science Goes Red™ collection. Science Goes Red™ is an initiative of Go Red for Women®, the American Heart Association’s global movement to end heart disease and stroke in women.For Sources of Funding and Disclosures, see page 616.Circulation is available at www.ahajournals.org/journal/circRegistration: URL: https://www.anzctr.org.au/TrialSearch.aspx; Unique identifier: ANZCTR12620000007932.Correspondence to: Alexandra C. Murphy, MBBS, BMedSci, Department of Cardiology, Austin Hospital, 145 Studley Rd, Heidelberg 3084, Victoria, Australia. Email alex.murphy@austin.org.auReferences1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics.CA Cancer J Clin. 2011; 61:69–90. doi: 10.3322/caac.20107CrossrefMedlineGoogle Scholar2. Vo JB, Ramin C, Barac A, Berrington de Gonzalez A, Veiga L. Trends in heart disease mortality among breast cancer survivors in the US, 1975–2017.Breast Cancer Res Treat. 2022; 192:611–622. doi: 10.1007/s10549-022-06515-5CrossrefMedlineGoogle Scholar3. Granger CL, Holland AE, Gordon IR, Denehy L. Minimal important difference of the 6-minute walk distance in lung cancer.Chron Respir Dis. 2015; 12:146–154. doi: 10.1177/1479972315575715CrossrefMedlineGoogle Scholar4. Murphy AC, Farouque O, Yeo B, Dick R, Koshy AN, Roccisano L, Reid C, Raman J, Kearney L, Yudi MB. SMARTphone based cardiovascular risk reduction in BREAST cancer patients (SMART-BREAST): a randomised controlled trial protocol.Heart Lung Circ. 2021; 30:1314–1319. doi: 10.1016/j.hlc.2021.03.271CrossrefMedlineGoogle Scholar5. Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies.Med Oncol. 2011; 28:753–765. doi: 10.1007/s12032-010-9536-xCrossrefMedlineGoogle Scholar eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. 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Circulation. 2023;147:546-548 February 14, 2023Vol 147, Issue 7 Advertisement Article InformationMetrics © 2023 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.122.062946PMID: 36342665 Originally publishedNovember 7, 2022 Keywordsmobile applicationsbreast neoplasmssmartphonewalk testcardiovascular diseasesPDF download Advertisement SubjectsClinical Studies