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乳腺癌电子支持项目移动应用程序与常规护理用于中国乳腺癌化疗女性治疗的比较:一项随机对照试验的研究方案

A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial.

作者信息

Zhu Jiemin, Ebert Lyn, Liu Xiangyu, Chan Sally Wai-Chi

机构信息

Nursing Department, Medical College of Xiamen University, Xiangan Nan road, Xiangan District, Xiamen city, Fujian Province, 361102, People's Republic of China.

School of Nursing and Midwifery, Faculty of Health and Medicine, University of Newcastles, Richardson Wing, Callaghan University Drive, Callaghan, NSW, 2308, Australia.

出版信息

BMC Cancer. 2017 Apr 26;17(1):291. doi: 10.1186/s12885-017-3276-7.

DOI:10.1186/s12885-017-3276-7
PMID:28446141
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5406970/
Abstract

BACKGROUND

Women with breast cancer undergoing chemotherapy suffer from a number of symptoms and report receiving inadequate support from health care professionals. Innovative and easily accessible interventions are lacking. Breast Cancer e-Support is a mobile Application program (App) that provides patients with individually tailored information and a support group of peers and health care professionals. Breast Cancer e-Support aims to promote women's self-efficacy, social support and symptom management, thus improving their quality of life and psychological well-being.

METHODS

A single-blinded, multi-centre, randomised, 6-month, parallel-group superiority design will be used. Based on Bandura's self-efficacy theory and the social exchange theory, Breast Cancer e-Support has four modules: 1) a Learning forum; 2) a Discussion forum; 3) an Ask-the-Expert forum; and 4) a Personal Stories forum. Women with breast cancer (n = 108) who are commencing chemotherapy will be recruited from two university-affiliated hospitals in China. They will be randomly assigned to either control group that receives routine care or intervention group that receives routine care plus access to Breast Cancer e-Support program during their four cycles of chemotherapy. Self-efficacy, social support, symptom distress, quality of life, and anxiety and depression will be measured at baseline, then one week and 12 weeks post-intervention.

DISCUSSION

This is the first study of its kind in China to evaluate the use of a mobile application intervention with a rigorous research design and theoretical framework. This study will contribute to evidence regarding the effectiveness of a theory-based mobile application to support women with breast cancer undergoing chemotherapy. The results should provide a better understanding of the role of self-efficacy and social support in reducing symptom distress and of the credibility of using a theoretical framework to develop internet-based interventions. The results will provide evidence to support the implementation of an innovative and easily accessible intervention that enhances health outcomes.

TRIAL REGISTRATION

ACTRN: ACTRN12616000639426 , Registered 17 May, 2016.

摘要

背景

接受化疗的乳腺癌女性会出现多种症状,且她们表示从医护人员那里得到的支持不足。目前缺乏创新且易于获取的干预措施。乳腺癌电子支持是一个移动应用程序(App),为患者提供个性化定制信息以及由同龄人及医护人员组成的支持小组。乳腺癌电子支持旨在提高女性的自我效能感、社会支持和症状管理能力,从而改善她们的生活质量和心理健康。

方法

将采用单盲、多中心、随机、为期6个月的平行组优效性设计。基于班杜拉的自我效能理论和社会交换理论,乳腺癌电子支持有四个模块:1)学习论坛;2)讨论论坛;3)专家问答论坛;4)个人故事论坛。将从中国两家大学附属医院招募开始接受化疗的乳腺癌女性(n = 108)。她们将被随机分配到接受常规护理的对照组或在四个化疗周期中接受常规护理并可使用乳腺癌电子支持项目的干预组。将在基线时、干预后1周和12周测量自我效能感、社会支持、症状困扰、生活质量以及焦虑和抑郁情况。

讨论

这是中国首例采用严谨研究设计和理论框架评估移动应用干预措施使用情况的研究。本研究将为基于理论的移动应用对支持接受化疗的乳腺癌女性的有效性提供证据。研究结果应能让人更好地理解自我效能感和社会支持在减轻症状困扰方面的作用,以及使用理论框架开发基于互联网的干预措施的可信度。研究结果将为支持实施能改善健康结局的创新且易于获取的干预措施提供证据。

试验注册

ACTRN:ACTRN12616000639426,于2016年5月17日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad4/5406970/a0d3d54d8af0/12885_2017_3276_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad4/5406970/6ba39adb860d/12885_2017_3276_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad4/5406970/79f6b71b6e4e/12885_2017_3276_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad4/5406970/a0d3d54d8af0/12885_2017_3276_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad4/5406970/6ba39adb860d/12885_2017_3276_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad4/5406970/79f6b71b6e4e/12885_2017_3276_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ad4/5406970/a0d3d54d8af0/12885_2017_3276_Fig3_HTML.jpg

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