School of Medicine, Xiamen University, Xiamen, Fujian Province, P. R. China.
President Office, Tung Wah College, Hong Kong, P. R. China.
J Adv Nurs. 2021 May;77(5):2539-2548. doi: 10.1111/jan.14809. Epub 2021 Feb 23.
Patients with gynaecological cancer often experience high levels of uncertainty in illness during chemotherapy and report unmet supportive care needs. Mobile applications (apps) are increasing being used as an easily accessible alternative to support these patients, but a lack of rigorous trials have been conducted to explore their effectiveness. Based on Mishel's uncertainty in illness theory, the Mobile Gynaecological Cancer Support (MGCS) program is an app-based program that includes four modules: 1) weekly topics, 2) emotional care, 3) discussion centre and 4) health consultation. The aim of this study is to assess the effectiveness of MGCS for Chinese patients with gynaecological cancer receiving chemotherapy in respect of reducing uncertainty in illness and symptom distress and improving quality of life and social support.
A multi-centre randomized controlled trial will be used.
One hundred and sixty-eight patients with gynaecological cancer commencing chemotherapy will be recruited from three university affiliated hospitals and assigned to the control or intervention group with block randomization. The control group will only receive routine care. The intervention group will access the MGCS program for 24 weeks and receive routine care. Health outcomes will be evaluated at baseline, 12 weeks, and 24 weeks. Repeated measures multivariate analysis of covariance (intention-to-treat) will be used to assess the effectiveness of MGCS.
This is the first trial to explore the effectiveness of an app-based program for patients with gynaecological cancer using a robust and rigorous study design in China. If effective, this trial will provide evidence for an app-based program to support these patients.
The knowledge gained can be applied to develop other culturally appropriate app-based programs for cancer groups worldwide, and provide evidence for health policymakers to allocate more resources and train staff for e-health.
ChiCTR2000033678 (Chinese Clinical Trial Registry Registered 08 June, 2020).
妇科癌症患者在化疗期间经常经历高度的疾病不确定性，并报告未满足的支持性护理需求。移动应用程序（apps）越来越多地被用作支持这些患者的便捷替代方式，但缺乏严格的试验来探索其有效性。基于米舍尔的疾病不确定性理论，移动妇科癌症支持（MGCS）计划是一个基于应用程序的计划，包括四个模块：1）每周主题，2）情绪护理，3）讨论中心和 4）健康咨询。本研究旨在评估 MGCS 对接受化疗的中国妇科癌症患者在降低疾病不确定性和症状困扰、提高生活质量和社会支持方面的有效性。
将使用多中心随机对照试验。
将从三所大学附属医院招募 168 名开始化疗的妇科癌症患者，并采用区组随机分组将其分配到对照组或干预组。对照组仅接受常规护理。干预组将在 24 周内访问 MGCS 计划并接受常规护理。将在基线、12 周和 24 周评估健康结果。将使用重复测量多元协方差分析（意向治疗）来评估 MGCS 的有效性。
这是第一项在中国使用稳健而严格的研究设计探索基于应用程序的程序对妇科癌症患者有效性的试验。如果有效，该试验将为基于应用程序的程序为这些患者提供支持提供证据。
获得的知识可应用于为全球癌症群体开发其他文化上适当的基于应用程序的程序，并为卫生政策制定者提供证据，以分配更多资源并培训员工使用电子健康。
ChiCTR2000033678（中国临床试验注册中心于 2020 年 6 月 8 日注册）。
