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一项针对癌症患者及康复者在监督下进行体育活动时增加行为咨询的随机对照试验(BOOST-UP-):一项关于远程实时提供行为改变干预措施的研究方案。

A randomized controlled trial adding behavioral counseling to supervised physical activity in people living with and beyond cancer (BOOST-UP-): a study protocol for a live remotely-delivered behavior change intervention.

作者信息

Trinh Linda, Rhodes Ryan E, Alibhai Shabbir M H, Campbell Kristin L, Langelier David M, Chang Eugene, Colella Tracey, Chan Brian, Santa Mina Daniel, Oh Paul, McAuley Edward

机构信息

Faculty of Kinesiology and Physical Education, University of Toronto, 55 Harbord Street, Toronto, ON, M5S 2W6, Canada.

School of Exercise Science, Physical and Health Education, University of Victoria, 11 Gabriola Rd, Victoria, British Columbia, V8P 5C2, Canada.

出版信息

BMC Cancer. 2025 May 9;25(1):847. doi: 10.1186/s12885-025-13904-8.

DOI:10.1186/s12885-025-13904-8
PMID:40346460
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12063396/
Abstract

BACKGROUND

For many people living with and beyond cancer (LWBC), physical activity (PA) declines significantly after supervised PA interventions. The effect of short-term, supervised PA interventions on motivational outcomes and longer-term PA in people LWBC is limited, especially theoretically-based approaches to identify key motivational outcomes for behavior change. The purpose of this study is to compare the effects of a 6-month virtual supervised PA group plus standard exercise counseling (PA + EC) versus a virtual supervised PA plus motivationally-enhanced behavioral counseling (PA + BC) group on moderate-to-vigorous intensity PA (MVPA) in people LWBC.

METHODS

This study is a two-armed, multi-site randomized controlled trial (RCT). People LWBC will be recruited and randomized to a 6-month virtual supervised PA intervention plus standard exercise counseling (PA + EC group; n = 118) or a 6-month virtual supervised PA plus behavioral counseling based on the Multi-Process Action Control (M-PAC) framework (PA + BC group; n = 118). Supervised PA will be delivered via synchronous Zoom classes that tapers to a home-based protocol at the end of the study. The goal of both groups is to gradually increase PA to the cancer PA guidelines (e.g., 90 min of MVPA/week). The PA + BC group will receive twelve behavioral counseling sessions with a qualified exercise professional (QEP), and the corresponding counseling session will be delivered bi-weekly. The behavioral counseling sessions will be based on the M-PAC's reflective, regulatory, and reflexive processes. In addition to the supervised PA classes, the PA + EC (i.e., attention control group) will receive twelve standard PA counseling sessions based on PA training principles. People LWBC will complete measures at baseline, midpoint, post-intervention (6-months), at 6-months follow-up, and 1-year follow-up. Self-reported measures include quality of life (QoL), motivational outcomes, health economics, and patient satisfaction. Objective measures include PA via accelerometry. Multilevel modelling will examine change in the primary (i.e., PA) and secondary outcomes (i.e., motivational outcomes from the M-PAC, physical function, QoL) at the five time points.

DISCUSSION

This study will create greater understanding on efficacious programming to support PA maintenance that can be used by clinical and community-based organizations as a low-cost, supportive care tool to improve health outcomes for people LWBC.

TRIAL REGISTRATION

Clinicaltrials.gov ID NCT06624930.

摘要

背景

对于许多癌症生存者及康复者(LWBC)而言,在有监督的体育活动干预后,身体活动(PA)显著下降。短期、有监督的PA干预对LWBC人群的动机结果和长期PA的影响有限,尤其是基于理论的确定行为改变关键动机结果的方法。本研究的目的是比较为期6个月的虚拟监督PA组加标准运动咨询(PA + EC)与虚拟监督PA加动机增强行为咨询(PA + BC)组对LWBC人群中等到高强度PA(MVPA)的影响。

方法

本研究是一项双臂、多中心随机对照试验(RCT)。将招募LWBC人群并随机分为为期6个月的虚拟监督PA干预加标准运动咨询组(PA + EC组;n = 118)或为期6个月的虚拟监督PA加基于多过程行动控制(M - PAC)框架的行为咨询组(PA + BC组;n = 118)。有监督的PA将通过同步Zoom课程进行,并在研究结束时逐渐过渡到家庭训练方案。两组的目标都是将PA逐渐增加到癌症PA指南的水平(例如,每周90分钟的MVPA)。PA + BC组将与合格的运动专业人员(QEP)进行十二次行为咨询,相应的咨询将每两周进行一次。行为咨询将基于M - PAC的反思、调节和自反过程。除了有监督的PA课程外,PA + EC组(即注意力控制组)将基于PA训练原则接受十二次标准PA咨询。LWBC人群将在基线、中点、干预后(6个月)、6个月随访和1年随访时完成测量。自我报告的测量包括生活质量(QoL)、动机结果、健康经济学和患者满意度。客观测量包括通过加速度计测量的PA。多层次建模将在五个时间点检查主要结果(即PA)和次要结果(即来自M - PAC的动机结果、身体功能、QoL)的变化。

讨论

本研究将使人们对支持PA维持的有效方案有更深入的了解,临床和社区组织可将其用作低成本的支持性护理工具,以改善LWBC人群的健康结果。

试验注册

Clinicaltrials.gov标识符NCT06624930。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cebd/12063396/455a95fa2b0a/12885_2025_13904_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cebd/12063396/50c4a91a9132/12885_2025_13904_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cebd/12063396/455a95fa2b0a/12885_2025_13904_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cebd/12063396/50c4a91a9132/12885_2025_13904_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cebd/12063396/455a95fa2b0a/12885_2025_13904_Fig2_HTML.jpg

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