Hu Yuru, Peng Huan, Su Guoqiang, Chen Bo, Yang Zhiping, Ye Yafang, Zhou Beiyun, Lin Sumin, Deng Huili, Zhang Jiajun, Xie Yaojie, He Honggu, Ruan Zheng, Shen Qu
School of Medicine, Xiamen University, Xiamen, China.
Teaching and Research Section of Clinical Nursing, Xiangya Hospital of Central South University, Changsha, China.
Digit Health. 2024 Nov 18;10:20552076241295542. doi: 10.1177/20552076241295542. eCollection 2024 Jan-Dec.
Regular rehabilitation during or after cancer treatment can bring numerous benefits to colorectal cancer survivors. However, there is a lack of convenient and mobile rehabilitation support systems tailored specifically for this group. The metaverse, as a virtual reality environment, offers an innovative platform for implementing rehabilitation. Hence, our study aims to develop a metaverse-based multimodal rehabilitation program and assess its effects on enhancing outcome measures such as quality of life in colorectal cancer patients.
This study was designed as a randomized, single-blind controlled trial design featuring two arms: a rehabilitation group and a conventional care group. Sixty colorectal cancer survivors who have undergone curative surgery followed by adjuvant chemotherapy will be recruited for this study. The intervention will take place within the metaverse over a 4-week period. Assessments will be conducted at baseline and after 4 weeks. The intervention is grounded in the behavior change wheel framework and encompasses dietary intervention, exercise intervention, psychological support, and behavior management. Through the implementation of diverse strategies such as training, education, and motivation, our objective is to enhance patients' capacity, opportunities, and motivation, ultimately fostering healthy behaviors. Outcome measures will encompass quality of life, fear of recurrence, and lifestyle.
The analysis includes statistical description and inference. Quantitative data will be summarized using mean ± standard deviation for normally distributed data and medians with percentiles for non-normally distributed data. Categorical data will be presented as frequencies and percentages. Statistical tests will detect significant differences between pre- and post-intervention periods. Subgroup analysis will explore CRC stage, age, and gender in relation to outcome measures to identify factors affecting intervention efficacy.
The findings from this research will offer valuable insights and practical implications for the implementation of remote interventions and family-based interventions in the context of colorectal cancer survivorship.
NCT05956990 (Registered 21 July 2023).
癌症治疗期间或之后的定期康复可为结直肠癌幸存者带来诸多益处。然而,目前缺乏专门为该群体量身定制的便捷移动康复支持系统。元宇宙作为一种虚拟现实环境,为实施康复提供了一个创新平台。因此,我们的研究旨在开发一个基于元宇宙的多模式康复项目,并评估其对改善结直肠癌患者生活质量等结局指标的效果。
本研究设计为随机、单盲对照试验,分为两组:康复组和常规护理组。将招募60名接受了根治性手术并随后接受辅助化疗的结直肠癌幸存者参与本研究。干预将在元宇宙中进行,为期4周。将在基线和4周后进行评估。该干预基于行为改变轮框架,包括饮食干预、运动干预、心理支持和行为管理。通过实施培训、教育和激励等多种策略,我们的目标是提高患者的能力、机会和动力,最终促进健康行为。结局指标将包括生活质量、对复发的恐惧和生活方式。
分析包括统计描述和推断。对于正态分布的数据,定量数据将使用均值±标准差进行汇总,对于非正态分布的数据,将使用中位数和百分位数进行汇总。分类数据将以频率和百分比的形式呈现。统计检验将检测干预前后的显著差异。亚组分析将探讨结直肠癌分期、年龄和性别与结局指标的关系,以确定影响干预效果的因素。
本研究的结果将为在结直肠癌幸存者背景下实施远程干预和家庭干预提供有价值的见解和实际意义。
NCT05956990(2023年7月21日注册)。