De Groef An, Dams Lore, Moseley G Lorimer, Heathcote Lauren C, Wiles Louise K, Catley Mark, Vogelzang Anna, Hibbert Peter, Morlion Bart, Van Overbeke Marthe, Tack Emma, Van Dijck Sophie, Devoogdt Nele, Gursen Ceren, De Paepe Annick L, Mertens Michel, van Olmen Josefien, Willem Lander, Tjalma Wiebren, Nevelsteen Ines, Neven Patrick, Vanhoudt Rani, Wildemeersch Davina, De Backere Femke, Fieuws Steffen, Crombez Geert, Meeus Mira
Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium
Department of Rehabilitation Sciences, University of Antwerp, Antwerp, Belgium.
BMJ Open. 2025 Aug 22;15(8):e099241. doi: 10.1136/bmjopen-2025-099241.
Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).
A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The 'eHealth self-management support programme' begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The 'usual care programme' involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The 'face-to-face self-management support programme' mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.
The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.
ClinicalTrials.gov Identifier: NCT06308029.
乳腺癌治疗结束后持续存在的疼痛是一个常见且致残的问题。当前最先进的疼痛管理提倡，除了生物医学（非）药物治疗方法外，采用生物心理社会康复方法来解决持续性疼痛，将疼痛科学教育与通过自我调节技术促进积极的生活方式相结合。我们建议针对完成癌症治疗后仍有持续性疼痛的乳腺癌患者群体，测试一种创新的电子健康自我管理支持计划。这种提供方式被认为可以通过提供及时、安全且具有成本效益的援助来满足患者的生物心理社会需求，从而减少疼痛自我管理的障碍。利用聊天机器人形式，该电子健康计划提供疼痛科学教育并促进身体活动（PA），通过基于决策树的算法进行个性化设置以支持疼痛自我管理。该计划旨在使患者具备理解、应对技巧和自我管理技术，以减少与疼痛相关的残疾并增强日常生活参与度。主要目标是确定该计划与（1）常规护理（优越性）和（2）类似的面对面疼痛自我管理支持计划（非劣效性）相比的有效性。
2024年4月在比利时安特卫普大学医院和鲁汶大学医院以及初级保健机构开展了一项实用的三臂随机对照试验。参与者为完成癌症治疗后仍有持续性疼痛的乳腺癌幸存者。270名参与者将被随机分配到三个试验组之一：（1）电子健康自我管理支持计划，（2）常规护理或（3）面对面自我管理支持计划。“电子健康自我管理支持计划”首先是一个疼痛科学教育（PSE）模块，初步传达关键的疼痛相关概念并提供个性化的疼痛管理建议。然后，该计划进入日常活动规划，以促进积极的生活方式。在健康行动过程方法（HAPA）模型的指导下，参与者设定并回顾日常活动目标并跟踪进展。电子健康自我管理计划使用聊天机器人，可在任何数字设备上访问。“常规护理计划”包括通过邮政邮件向参与者发送一份特定研究的宣传册，不包括任何正式的PSE和/或PA计划。他们可以寻求或继续自行开始的护理。在比利时，常规护理主要包括药物治疗、关于PA的一般建议以及提供信息宣传册。“面对面自我管理支持计划”模仿电子健康干预，将PSE与PA指导相结合。它首先与一名经过培训的物理治疗师进行三次个人会诊，进行生物心理社会评估和PSE，随后进行六次关于目标设定和积极生活方式指导的会诊。教育内容以口头和书面形式提供。主要结局将是基线评估后6个月与疼痛相关的残疾情况。作为关键的次要结局，将在电子健康和面对面计划的教育部分之后（即基线后6周）调查对疼痛信念和态度的影响。与疼痛的其他维度以及身体、心理社会和健康经济结局相关的其他次要结局也将在基线后12周、6个月和12个月进行评估。
本研究将按照《赫尔辛基宣言》（2024年）进行。该方案已获得鲁汶大学医院和安特卫普大学医院伦理委员会的批准。结果将通过同行评审的科学期刊和在大会上的报告进行传播。鲁汶大学医院和安特卫普大学医院伦理委员会：BUN B3002023000132。
ClinicalTrials.gov标识符：NCT06308029。
