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ACTIVity And TEchnology(ACTIVATE)试验的研究设计与方法

Study design and methods for the ACTIVity And TEchnology (ACTIVATE) trial.

作者信息

Lynch Brigid M, Nguyen Nga H, Reeves Marina M, Moore Melissa M, Rosenberg Dori E, Wheeler Michael J, Boyle Terry, Vallance Jeff K, Friedenreich Christine M, English Dallas R

机构信息

Cancer Epidemiology and Intelligence Division, Cancer Council Victoria, Melbourne, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Australia; Physical Activity Laboratory, Baker Heart and Diabetes Institute, Melbourne, Australia.

Cancer Epidemiology and Intelligence Division, Cancer Council Victoria, Melbourne, Australia.

出版信息

Contemp Clin Trials. 2018 Jan;64:112-117. doi: 10.1016/j.cct.2017.10.015. Epub 2017 Oct 31.

DOI:10.1016/j.cct.2017.10.015
PMID:29097298
Abstract

BACKGROUND

Physical activity is positively associated with survival and quality of life among breast cancer survivors. Despite these benefits, the majority of breast cancer survivors are insufficiently active. The potential health benefits of reducing sedentary behaviour (sitting time) in this population have not been extensively investigated. The ACTIVATE Trial will evaluate the efficacy of an intervention that combines wearable technology (the Garmin Vivofit2®) with traditional behavioural change approaches to increase physical activity and reduce sedentary behaviour performed by breast cancer survivors.

METHODS/DESIGN: This randomised controlled trial includes inactive, postmenopausal women diagnosed with stage I-III breast cancer who have completed their primary treatment. Participants are randomly assigned to the primary intervention group (Garmin Vivofit2®; behavioural feedback and goal setting session; and, five telephone-delivered health coaching sessions) or to the wait-list control group. The primary intervention is delivered over a 12-week period. The second 12-week period comprises a maintenance phase for the primary intervention group, and an abridged intervention (Garmin Vivofit2® only) for the wait-list control group. Moderate- to vigorous-intensity physical activity (MVPA) and sedentary behaviour are assessed by accelerometry at baseline (T1), end of intervention (T2), and end of maintenance phase (T3).

DISCUSSION

The ACTIVATE Trial is one of the first studies to incorporate wearable technology into an intervention for cancer survivors. If the use of wearable technology (in combination with behaviour change strategies, or alone) proves efficacious, it may become an inexpensive and sustainable addition to the health promotion strategies available to health care providers in the cancer survivorship context.

TRIAL REGISTRATION

ACTRN12616000175471.

摘要

背景

体育活动与乳腺癌幸存者的生存率和生活质量呈正相关。尽管有这些益处,但大多数乳腺癌幸存者的活动量仍不足。减少该人群久坐行为(坐姿时间)对健康的潜在益处尚未得到广泛研究。ACTIVATE试验将评估一种干预措施的效果,该措施将可穿戴技术(佳明Vivofit2®)与传统行为改变方法相结合,以增加乳腺癌幸存者的体育活动并减少其久坐行为。

方法/设计:这项随机对照试验纳入了已完成初始治疗、被诊断为I-III期乳腺癌的绝经后不活动女性。参与者被随机分配到主要干预组(佳明Vivofit2®;行为反馈和目标设定环节;以及五次电话健康指导课程)或等待名单对照组。主要干预为期12周。第二个12周阶段包括主要干预组的维持阶段,以及等待名单对照组的简化干预(仅使用佳明Vivofit2®)。在基线(T1)、干预结束时(T2)和维持阶段结束时(T3)通过加速度计评估中度至剧烈强度的体育活动(MVPA)和久坐行为。

讨论

ACTIVATE试验是首批将可穿戴技术纳入癌症幸存者干预措施的研究之一。如果使用可穿戴技术(与行为改变策略结合或单独使用)被证明有效,它可能成为医疗保健提供者在癌症幸存者背景下可采用的健康促进策略中一种经济且可持续的补充。

试验注册

ACTRN12616000175471。

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