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

Anna C Singleton; Stephanie R Partridge; Karice K Hyun; Christine Mitchell; Rebecca Raeside; Nashid Hafiz; Brooke Nickel; David Mizrahi; Allyson Ruth Todd; Jennifer McIntosh; Raymond J Chan; Kirsty E Stuart; Carolyn Ee; Elisabeth Elder; Julie Redfern

doi:10.1136/bmjopen-2024-090984

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. 2024 Dec 11;14(12):e090984. doi: 10.1136/bmjopen-2024-090984.

Authors

Anna C Singleton^{1

2}, Stephanie R Partridge^{2

3}, Karice K Hyun^{4

5}, Christine Mitchell⁶, Rebecca Raeside², Nashid Hafiz⁵, Brooke Nickel^{7

8}, David Mizrahi⁹, Allyson Ruth Todd^{2

3}, Jennifer McIntosh¹⁰, Raymond J Chan¹¹, Kirsty E Stuart^{12

13

14}, Carolyn Ee^{11

15

16}, Elisabeth Elder^{12

14}, Julie Redfern¹⁷

Affiliations

¹ The Daffodil Centre, a joint venture between the University of Sydney and Cancer Council New South Wales, The University of Sydney, Sydney, New South Wales, Australia anna.singleton@sydney.edu.au.
² Susan Wakil School of Nursing and Midwifery, The University of Sydney, Sydney, NSW, Australia.
³ Charles Perkins Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁴ ANZAC Research Institute, Concord Repatriation General Hospital, Concord, New South Wales, Australia.
⁵ School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁶ Consumer Representative Group, Breast Cancer Network Australia, Camberwell, Victoria, Australia.
⁷ Sydney Health Literacy Lab, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁸ Wiser Healthcare, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁹ The Daffodil Centre, a joint venture between the University of Sydney and Cancer Council New South Wales, The University of Sydney, Sydney, New South Wales, Australia.
¹⁰ Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
¹¹ Caring Futures Institute, Flinders University, Adelaide, South Australia, Australia.
¹² Westmead Breast Cancer Institute, Westmead Hospital, Western Sydney Local Health District, Sydney, New South Wales, Australia.
¹³ Radiation Oncology Network, Western Sydney Local Health District, Sydney, New South Wales, Australia.
¹⁴ Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
¹⁵ NICM Health Research Institute, Western Sydney University, Sydney, New South Wales, Australia.
¹⁶ Translational Health Research Institute, Western Sydney University, Sydney, New South Wales, Australia.
¹⁷ Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia.

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).

Keywords: Cell Phone; Health Services; Implementation Science; ONCOLOGY; PUBLIC HEALTH; Primary Care.

Publication types

Clinical Trial Protocol
Randomized Controlled Trial

MeSH terms

Australia
Breast Neoplasms*
Cancer Survivors*
Cardiovascular Diseases / prevention & control
Exercise*
Female
General Practice / methods
Health Promotion / methods
Heart Disease Risk Factors
Humans
Randomized Controlled Trials as Topic
Single-Blind Method
Text Messaging*