Zhao Xia, Fan Min, Ding Yanan, Pan Yuqin, Zhang Xinqiong
School of Nursing, Anhui Medical University, Hefei, Anhui, China.
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
PLoS One. 2025 Aug 13;20(8):e0329834. doi: 10.1371/journal.pone.0329834. eCollection 2025.
BACKGROUND: Gastric 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. METHODS: The 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. DISCUSSION: This 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 REGISTRATION: The 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,患者常常因各种治疗而遭受严重的心理困扰。适应力,即积极应对挑战的能力,对胃癌患者的身心健康至关重要。尽管其重要性不言而喻,但旨在增强适应力的研究仍存在空白。本文介绍了一项过程评估方案,该方案嵌入了一项旨在增强胃癌患者化疗期间适应力的复杂干预措施中。该方案旨在了解实施过程、机制、影响因素和结果。 方法:过程评估将采用混合方法。选择实施研究综合框架(CFIR)和RE-AIM框架,以定性识别影响干预实施的因素和实施结果,包括覆盖范围、效果、采用率和维持率。将根据英国医学研究理事会关于评估复杂干预措施的指南评估实施过程。将通过目标达成日志分析保真度、剂量和依从性,并使用具有定量信息的平行潜在增长曲线模型评估干预实施的机制。将与干预工作人员和参与者进行半结构化访谈,分析目标达成日志中的数据,并分析主要和次要结果指标的数据以获取平行潜在增长曲线参数。 讨论:本研究概述了一项复杂干预措施的过程评估方案。该方案旨在进一步验证干预措施的有效性,并指导制定更全面的适应力策略,从而促进在其他慢性病患者群体中的更广泛应用。 试验注册:该试验已于2023年7月日进行前瞻性注册;ChiCTR2300073466。 (注:原文中“11 July 2023”的“日”未给出具体数字)
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