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
Year: 2024
Type: article
Study design: Study Protocol
Abstract: 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).
Source: BMJ Open
Institutions: The University of Sydney, Cancer Council NSW, Concord Repatriation General Hospital, Anzac Research Institute, Breast Cancer Network Australia, The University of Melbourne, Flinders University, Caring Futures Institute, Westmead Hospital, Western Sydney Local Health District, Western Sydney University, Bond University
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
Awards: SMARTERscreen: A randomised controlled trial of patient SMS messaging in general practice to increase participation in the National Bowel Cancer Screening Program, G2231760287, The impact of breast density notification in Australia, Tackling Australia’s low screening participation to prevent bowel cancer morbidity and deaths, Solving the long-standing evidence-practice gap associated with cardiac rehabilitation and secondary prevention of coronary heart disease (SOLVE-CHD), Modernising cardiac rehabilitation and secondary prevention of heart disease, Improving influenza vaccination rate for the prevention of cardiovascular events, G5674839156, Optimising Primary Care for Cancer Survivorship, Scalable Survivorship Support after Cancer (CanSupport): Evaluation of a co-designed and automated eHealth intervention to support cancer survivors in primary care
OpenAlex ID: W4405349371