Acti-Pair计划对前列腺癌患者身体活动的影响:Acti-Pair 2阶梯式楔形整群随机试验方案

Impact of the Acti-Pair programme on physical activity in patients with prostate cancer: protocol of the Acti-Pair 2 stepped-wedge cluster randomised trial.

作者信息

Baudot Amandine, Fayolle Evolene, Garros Maël, Barth Nathalie, Colin Florence, Presles Emilie, Oriol Mathieu, Collange Fanny, Chauvin Franck, Bourmaud Aurélie, Hupin David

机构信息

U1059 INSERM, SAINBIOSE, DVH, Lyon University, Jean Monnet University, Saint-Etienne, France.

INSERM, CIC 1408, University Hospital Centre, Saint-Etienne, France.

出版信息

BMJ Open Sport Exerc Med. 2024 Dec 22;10(4):e002344. doi: 10.1136/bmjsem-2024-002344. eCollection 2024.

Abstract

Regular physical activity (PA) reduces morbidity and mortality in prostate cancer. Prescribing PA in cancer is a necessary awareness but is a real challenge in the case of prostate cancer. Motivational peer support seems to be an innovative strategy for lifestyle change. Therefore, we developed the Acti-Pair programme and demonstrated its feasibility. We want to evaluate its effectiveness in promoting PA in patients with prostate cancer. The Acti-Pair 2 study is an interventional, comparative, multicentre, randomised, stepped-wedge cluster study. The control group will consist of patients being followed for prostate cancer and receiving advice and recommendations for PA during consultations to make patients more active in their daily lives (=usual practice, PA to be performed independently at home). The intervention group will consist of patients being followed up for prostate cancer and benefiting from the Acti-Pair programme, which combines three interventions: (1) motivational support from a peer; (2) construction of a personalised and realistic project and (3) support from health and adapted PA professionals. This study will assess the effectiveness, implementation and efficiency of the Acti-Pair programme. It will allow the identification of key success factors for implementing the Acti-Pair programme to prepare for its transferability. Trial registration number: Clinical trial, NCT05739565, registered on 20 February 2023, https://clinicaltrials.gov/study/NCT05739565..

摘要

规律的体育活动(PA)可降低前列腺癌的发病率和死亡率。在癌症治疗中开具体育活动的医嘱是一项必要的认知,但在前列腺癌治疗中却是一项真正的挑战。同伴激励支持似乎是一种促进生活方式改变的创新策略。因此,我们开发了“行动伙伴”计划并证明了其可行性。我们希望评估其在促进前列腺癌患者进行体育活动方面的有效性。“行动伙伴2”研究是一项干预性、对比性、多中心、随机、阶梯式楔形整群研究。对照组将包括接受前列腺癌随访且在咨询过程中接受体育活动建议的患者,以使患者在日常生活中更加活跃(即常规做法,在家中独立进行体育活动)。干预组将包括接受前列腺癌随访并受益于“行动伙伴”计划的患者,该计划结合了三项干预措施:(1)同伴的激励支持;(2)制定个性化且切实可行的计划;(3)健康及适应性体育活动专业人员的支持。本研究将评估“行动伙伴”计划的有效性、实施情况和效率。它将有助于确定实施“行动伙伴”计划的关键成功因素,为其可推广性做准备。试验注册号:临床试验,NCT05739565,于2023年2月20日注册,https://clinicaltrials.gov/study/NCT05739565

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0d6e/11664380/775b1a8bde54/bmjsem-10-4-g001.jpg

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