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
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
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乳腺癌电子支持计划的移动应用与常规护理在中国乳腺癌化疗女性治疗中的比较：随机对照试验的研究方案
DOI：
10.1186/s12885-017-3276-7
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发表时间：
2017-04-26
期刊：
影响因子：
3.8
通讯作者：
Chan, Sally Wai-Chi
中科院分区：
文献类型：
--
作者：
Zhu, Jiemin;Ebert, Lyn;Chan, Sally Wai-Chi
背景：接受化疗的乳腺癌妇女患有许多症状，并报告没有得到卫生保健专业人员的充分支持。缺乏创新和易于获得的干预措施。乳腺癌电子支持是一个移动应用程序（App），为患者提供量身定制的信息，以及由同行和医疗保健专业人员组成的支持小组。乳腺癌e-Support旨在提高女性的自我效能感、社会支持和症状管理，从而改善她们的生活质量和心理健康。方法采用单盲、多中心、随机、6个月、平行组优势设计。基于Bandura的自我效能理论和社会交换理论，乳腺癌e-Support有四个模块：1)学习论坛；2)论坛；3)专家提问论坛；4)个人故事论坛。开始化疗的乳腺癌女性（n= 108）将从中国两所大学附属医院招募。她们将被随机分配到对照组接受常规护理或干预组在四个化疗周期中接受常规护理并获得乳腺癌电子支持项目。自我效能、社会支持、症状困扰、生活质量、焦虑和抑郁将在干预后1周和12周进行基线测量。这是中国同类研究中首次以严谨的研究设计和理论框架来评估移动应用程序干预的使用。这项研究将为基于理论的移动应用程序的有效性提供证据，以支持接受化疗的乳腺癌妇女。研究结果可以更好地理解自我效能感和社会支持在减少症状困扰中的作用，以及使用理论框架开发基于互联网的干预措施的可信度。研究结果将提供证据，支持实施一种创新的、易于获得的干预措施，以提高健康结果。试验注册actrn: ACTRN12616000639426, 2016年5月17日注册。
BackgroundWomen 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.MethodsA 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.DiscussionThis 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 registrationACTRN: ACTRN12616000639426 , Registered 17 May, 2016.