Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWER-SMS-GP effectiveness implementation randomised controlled trial

Introduction Australian breast cancer survivors are at increased risk of cardiovascular disease and mortality, partly due to behavioural risk factors, including unhealthy diet and physical inactivity. Guidelines recommend health promotion delivered by general practitioners (GPs), but resources (ie,...

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Main Authors: Karice K Hyun, Christine Mitchell, Julie Redfern, Nashid Hafiz, Rebecca Raeside, Brooke Nickel, Carolyn Ee, Jennifer McIntosh, Elisabeth Elder, Raymond J Chan, David Mizrahi, Stephanie R Partridge, Anna C Singleton, Allyson Ruth Todd, Kirsty E Stuart
Format: Article
Language:English
Published: BMJ Publishing Group 2024-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/12/e090984.full
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author Karice K Hyun
Christine Mitchell
Julie Redfern
Nashid Hafiz
Rebecca Raeside
Brooke Nickel
Carolyn Ee
Jennifer McIntosh
Elisabeth Elder
Raymond J Chan
David Mizrahi
Stephanie R Partridge
Anna C Singleton
Allyson Ruth Todd
Kirsty E Stuart
author_facet Karice K Hyun
Christine Mitchell
Julie Redfern
Nashid Hafiz
Rebecca Raeside
Brooke Nickel
Carolyn Ee
Jennifer McIntosh
Elisabeth Elder
Raymond J Chan
David Mizrahi
Stephanie R Partridge
Anna C Singleton
Allyson Ruth Todd
Kirsty E Stuart
author_sort Karice K Hyun
collection DOAJ
description Introduction Australian breast cancer survivors are at increased risk of cardiovascular disease and mortality, partly due to behavioural risk factors, including unhealthy diet and physical inactivity. Guidelines recommend health promotion delivered by general practitioners (GPs), but resources (ie, time and funding) are limited. Text message interventions sent from general practice to survivors may offer a low-resource solution but have not been evaluated. This randomised controlled trial (RCT) aims to evaluate the effectiveness and implementation of a text message intervention called EMPOWER-SMS-GP in Australian general practices.Methods and analysis Multi-centre single-blind hybrid I RCT (n=678; 1:1 allocation) comparing EMPOWER-SMS-GP (n=339) to usual care (n=339) at 6 months (postintervention), 12, 18 and 24 months (maintenance) and parallel mixed-methods process evaluation using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Inclusion: adults (≥18 years old) with early-stage breast cancer, completed active treatment ≤3 years ago, have a mobile phone and attended ≥1 GP appointment within 24 months. Primary outcome: between-group difference in mean physical activity (metabolic equivalent minutes/day) at 6 months, measured using an accelerometer. Secondary outcomes include self-reported physical activity, diet, quality of life, financial or psychological distress, fear of cancer recurrence, endocrine therapy adherence and body mass index. Statistical analyses (intention-to-treat) will include t-test (primary outcome) and linear and logistic mixed-effects regression models.Ethics and dissemination Approval received from the University of Sydney Human Research Ethics Committee (Number 2023/081). Trial results will be disseminated in peer-reviewed publications, presentations, lay summaries, videos and audio for scientific, government and public audiences.Trial registration number Australia and New Zealand Clinical Trial Registry (ACTRN12624000591550, 09/05/2024; U1111-1307-3454).
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spelling doaj-art-7779023496e042d3982e29cd52d8d3572025-08-20T02:36:54ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-090984Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWER-SMS-GP effectiveness implementation randomised controlled trialKarice K Hyun0Christine Mitchell1Julie Redfern2Nashid Hafiz3Rebecca Raeside4Brooke Nickel5Carolyn Ee6Jennifer McIntosh7Elisabeth Elder8Raymond J Chan9David Mizrahi10Stephanie R Partridge11Anna C Singleton12Allyson Ruth Todd13Kirsty E Stuart14School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaConsumer Representative Group, Breast Cancer Network Australia, Camberwell, Victoria, AustraliaInstitute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, AustraliaSchool of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaSusan Wakil School of Nursing and Midwifery, The University of Sydney, Sydney, NSW, AustraliaSydney Health Literacy Lab, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaCaring Futures Institute, Flinders University, Adelaide, South Australia, AustraliaMelbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, AustraliaSydney Medical School, The University of Sydney, Sydney, New South Wales, AustraliaCaring Futures Institute, Flinders University, Adelaide, South Australia, AustraliaThe Daffodil Centre, a joint venture between the University of Sydney and Cancer Council New South Wales, The University of Sydney, Sydney, New South Wales, AustraliaSusan Wakil School of Nursing and Midwifery, The University of Sydney, Sydney, NSW, AustraliaThe Daffodil Centre, a joint venture between the University of Sydney and Cancer Council New South Wales, The University of Sydney, Sydney, New South Wales, AustraliaSusan Wakil School of Nursing and Midwifery, The University of Sydney, Sydney, NSW, AustraliaWestmead Breast Cancer Institute, Westmead Hospital, Western Sydney Local Health District, Sydney, New South Wales, AustraliaIntroduction Australian breast cancer survivors are at increased risk of cardiovascular disease and mortality, partly due to behavioural risk factors, including unhealthy diet and physical inactivity. Guidelines recommend health promotion delivered by general practitioners (GPs), but resources (ie, time and funding) are limited. Text message interventions sent from general practice to survivors may offer a low-resource solution but have not been evaluated. This randomised controlled trial (RCT) aims to evaluate the effectiveness and implementation of a text message intervention called EMPOWER-SMS-GP in Australian general practices.Methods and analysis Multi-centre single-blind hybrid I RCT (n=678; 1:1 allocation) comparing EMPOWER-SMS-GP (n=339) to usual care (n=339) at 6 months (postintervention), 12, 18 and 24 months (maintenance) and parallel mixed-methods process evaluation using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Inclusion: adults (≥18 years old) with early-stage breast cancer, completed active treatment ≤3 years ago, have a mobile phone and attended ≥1 GP appointment within 24 months. Primary outcome: between-group difference in mean physical activity (metabolic equivalent minutes/day) at 6 months, measured using an accelerometer. Secondary outcomes include self-reported physical activity, diet, quality of life, financial or psychological distress, fear of cancer recurrence, endocrine therapy adherence and body mass index. Statistical analyses (intention-to-treat) will include t-test (primary outcome) and linear and logistic mixed-effects regression models.Ethics and dissemination Approval received from the University of Sydney Human Research Ethics Committee (Number 2023/081). Trial results will be disseminated in peer-reviewed publications, presentations, lay summaries, videos and audio for scientific, government and public audiences.Trial registration number Australia and New Zealand Clinical Trial Registry (ACTRN12624000591550, 09/05/2024; U1111-1307-3454).https://bmjopen.bmj.com/content/14/12/e090984.full
spellingShingle Karice K Hyun
Christine Mitchell
Julie Redfern
Nashid Hafiz
Rebecca Raeside
Brooke Nickel
Carolyn Ee
Jennifer McIntosh
Elisabeth Elder
Raymond J Chan
David Mizrahi
Stephanie R Partridge
Anna C Singleton
Allyson Ruth Todd
Kirsty E Stuart
Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWER-SMS-GP effectiveness implementation randomised controlled trial
BMJ Open
title Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWER-SMS-GP effectiveness implementation randomised controlled trial
title_full Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWER-SMS-GP effectiveness implementation randomised controlled trial
title_fullStr Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWER-SMS-GP effectiveness implementation randomised controlled trial
title_full_unstemmed Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWER-SMS-GP effectiveness implementation randomised controlled trial
title_short Text message intervention delivered from Australian general practices to improve breast cancer survivors’ physical activity and cardiovascular risk factors: protocol for the EMPOWER-SMS-GP effectiveness implementation randomised controlled trial
title_sort text message intervention delivered from australian general practices to improve breast cancer survivors physical activity and cardiovascular risk factors protocol for the empower sms gp effectiveness implementation randomised controlled trial
url https://bmjopen.bmj.com/content/14/12/e090984.full
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