澳大利亚全科医疗提供的短信干预以改善乳腺癌幸存者的身体活动和心血管危险因素：EMPOWER-SMS-GP有效性实施随机对照试验方案
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.
作者信息
Singleton Anna C, Partridge Stephanie R, Hyun Karice K, Mitchell Christine, Raeside Rebecca, Hafiz Nashid, Nickel Brooke, Mizrahi David, Todd Allyson Ruth, McIntosh Jennifer, Chan Raymond J, Stuart Kirsty E, Ee Carolyn, Elder Elisabeth, Redfern Julie
机构信息
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
Susan Wakil School of Nursing and Midwifery, The University of Sydney, Sydney, NSW, Australia.
出版信息
BMJ Open. 2024 Dec 11;14(12):e090984. doi: 10.1136/bmjopen-2024-090984.
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).
引言
澳大利亚乳腺癌幸存者患心血管疾病和死亡的风险增加，部分原因是行为风险因素，包括不健康饮食和缺乏身体活动。指南建议由全科医生（GP）开展健康促进工作，但资源（即时间和资金）有限。从全科诊所向幸存者发送短信干预可能提供一种低资源解决方案，但尚未得到评估。这项随机对照试验（RCT）旨在评估澳大利亚全科诊所中一种名为EMPOWER-SMS-GP的短信干预的有效性和实施情况。
方法与分析
多中心单盲混合I型RCT（n = 678；1:1分配），在6个月（干预后）、12个月、18个月和24个月（维持期）将EMPOWER-SMS-GP（n = 339）与常规护理（n = 339）进行比较，并使用覆盖范围、有效性、采用率、实施情况和维持框架进行平行混合方法过程评估。
纳入标准
年龄≥18岁的早期乳腺癌成年患者，在≤3年前完成积极治疗，拥有手机且在24个月内就诊≥1次全科医生预约。
主要结局
6个月时使用加速度计测量的组间平均身体活动（代谢当量分钟/天）差异。次要结局包括自我报告的身体活动、饮食、生活质量、经济或心理困扰、对癌症复发的恐惧、内分泌治疗依从性和体重指数。统计分析（意向性分析）将包括t检验（主要结局）以及线性和逻辑混合效应回归模型。
伦理与传播
获得悉尼大学人类研究伦理委员会批准（编号2023/081）。试验结果将在同行评审出版物、报告、通俗摘要、视频和音频中传播，面向科学、政府和公众受众。
试验注册号
澳大利亚和新西兰临床试验注册中心（ACTRN12624000591550，2024年5月9日；U1111 - 1307 - 3454）
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