Smith-Turchyn Jenna, Sabiston Catherine M, Edward Holly, Richardson Julie, Nayiga Brenda K, Page Alicia, Brooks Dina, Mukherjee Som D
School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada
University of Toronto, Toronto, Ontario, Canada.
BMJ Open. 2025 Mar 27;15(3):e101013. doi: 10.1136/bmjopen-2025-101013.
The prevalence of cancer in Canada is growing, leading to multiple lasting side effects in survivors. The physical and psychosocial benefits of regular physical activity (PA) during and after treatment for individuals with cancer are well established, however, not well implemented in a clinical setting. The overall aim of this project is to build on previous work and conduct a multicentred randomised controlled trial (RCT) and evaluate the effectiveness of a novel implementation strategy using PA and self-management versus usual care during cancer treatment.
a hybrid implementation-effectiveness RCT will occur at five cancer centres across Ontario, Canada. eligible participants include adults with a cancer diagnosis (any type or stage) who are receiving treatment and cleared for exercise by their oncology care team. participants (n=129) will be randomised to one of three groups: (1) institution-based exercise and self-management (SM) (eight in-person sessions of aerobic exercise and eight SM modules), (2) SM alone (SM only: eight virtual modules) or (3) usual care (no intervention). the Reach, Effectiveness, Adoption, Implementation and Maintenance framework will assess implementation outcomes. The primary effectiveness outcome is self-report PA level postintervention. outcomes will be measured at four time points (baseline, postintervention, 6- and 12-month follow-up). Descriptive statistics will be used to present implementation outcomes. An analysis of covariance will assess change between groups over time.
Findings from this trial will build on previous work and inform the way PA services are provided within cancer institutions across Ontario, Canada, and inform decision-making on how to incorporate exercise evidence into real-world clinical practice in cancer care. The Hamilton Integrated Research Ethics Board (ID: 7673 & 17454) has approved this study. Results will be disseminated using a combination of peer-reviewed publications, conference presentations and community organisation presentations. Participants will contribute to dissemination by sharing 'participant perspectives', highlighting their experience in the project and thoughts on the implementation strategies used.
The study is registered on clinicaltrials.gov (ID: NCT06323707).
加拿大癌症的患病率正在上升，给幸存者带来多种长期副作用。对于癌症患者而言，治疗期间及治疗后进行规律体育活动（PA）对身体和心理社会方面有益，这一点已得到充分证实，但在临床环境中并未得到很好的实施。本项目的总体目标是在以往工作的基础上，开展一项多中心随机对照试验（RCT），并评估一种新颖的实施策略的有效性，该策略在癌症治疗期间使用体育活动和自我管理，与常规护理进行对比。
一项混合实施 - 效果RCT将在加拿大安大略省的五个癌症中心进行。符合条件的参与者包括患有癌症诊断（任何类型或阶段）且正在接受治疗并经肿瘤护理团队批准可进行运动的成年人。参与者（n = 129）将被随机分为三组之一：（1）基于机构的运动和自我管理（SM）（八次有氧运动面对面课程和八个SM模块），（2）仅自我管理（仅SM：八个虚拟模块）或（3）常规护理（无干预）。“覆盖、效果、采用、实施和维持”框架将评估实施结果。主要效果结果是干预后自我报告的PA水平。结果将在四个时间点（基线、干预后、6个月和12个月随访）进行测量。描述性统计将用于呈现实施结果。协方差分析将评估组间随时间的变化。
本试验的结果将基于以往工作，并为加拿大安大略省各癌症机构提供体育活动服务的方式提供信息，同时为如何将运动证据纳入癌症护理的实际临床实践的决策提供信息。汉密尔顿综合研究伦理委员会（ID：7673 & 17454）已批准本研究。结果将通过同行评审出版物、会议报告和社区组织报告相结合的方式进行传播。参与者将通过分享“参与者观点”来促进传播，突出他们在项目中的经历以及对所采用实施策略的看法。
该研究已在clinicaltrials.gov上注册（ID：NCT06323707）。
