Control group psychological nursing content.

BackgroundGastric cancer represents a global health burden, with patients often experiencing significant psychological distress due to various treatments. Resilience, the ability to adapt positively to challenges, is crucial for the mental and physical well-being of gastric cancer patients. Despite its importance, there are still gaps in research aimed at enhancing resilience. This paper presents a process evaluation protocol embedded within a complex intervention aimed at enhancing resilience in gastric cancer patients during chemotherapy. The protocol aims to understand the implementation process, mechanisms, influencing factors, and outcomes.MethodsThe process evaluation will use a mixed-methods approach. The Consolidated Framework for Implementation Research (CFIR) and the RE-AIM framework were chosen to qualitatively identify the factors that influence intervention implementation and the outcomes of implementation, including the reach, efficacy, adoption and maintenance. The implementation process will be assessed based on the UK Medical Research Council’s guidance on evaluating complex interventions. The fidelity, dose and adherence will be analysed through the goal achievement log book, and the mechanisms of intervention implementation will be assessed using parallel latent growth curve model with quantitative information. Semi-structured interviews will be conducted with intervention staff and participants, data from the goal achievement log book will be analyzed, and data from the primary and secondary outcome indicators will be analyzed for parallel latent growth curve parameters.DiscussionThis study outlines a process evaluation protocol for a complex intervention. The protocol aims to further validate the effectiveness of the intervention and guide the development of more comprehensive resilience strategies, thus promoting broader application among other chronic disease patient populations.Trial registrationThe trial has been prospectively registered on 11 July 2023; ChiCTR2300073466.背景 胃癌是一项全球性的健康负担，患者常因各类治疗手段承受显著的心理痛苦。韧性（resilience）指个体积极适应困境的能力，对胃癌患者的心理与生理健康至关重要。尽管其重要性不言而喻，但针对提升胃癌患者韧性的相关研究仍存在缺口。本文介绍了一项嵌入于复杂干预方案的过程评估方案，该方案旨在提升化疗期间胃癌患者的韧性。本方案旨在解析干预的实施流程、作用机制、影响因素与实施效果。 方法 本过程评估将采用混合研究方法。研究选取整合实施研究框架（Consolidated Framework for Implementation Research, CFIR）与RE-AIM框架，通过定性分析识别影响干预实施的相关因素及实施效果，包括干预的覆盖范围、有效性、采纳度与维持性。本研究将依据英国医学研究理事会（UK Medical Research Council）针对复杂干预评估的指南开展实施流程评估。干预的实施保真度、实施剂量与执行贴合度将通过目标达成日志进行分析；干预实施的作用机制将结合定量数据，采用平行潜变量增长曲线模型进行评估。此外，本研究将对干预实施人员与受试者开展半结构化访谈，对目标达成日志数据进行分析，并针对主要与次要结局指标的数据开展平行潜变量增长曲线参数分析。 讨论 本研究提出了一套针对复杂干预方案的过程评估方案，旨在进一步验证该干预措施的有效性，为制定更完善的韧性提升策略提供指导，进而推动该方案在其他慢性病患者群体中的更广泛应用。 试验注册 本试验已于2023年7月11日进行前瞻性注册，注册编号为ChiCTR2300073466。