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

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

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.

Keywords: Breast cancer; Chemotherapy; Internet; Psychological well-being; Quality of life; Self-efficacy; Social support; Symptom distress.

Figures

Fig. 1
Fig. 1
Theoretical framework of the Breast Cancer e-Support Program - adapted from Shorey et al. [21]
Fig. 2
Fig. 2
Screenshots of the BCS program home page and the four modules
Fig. 3
Fig. 3
CONSORT flowchart of the study - adapted from Schulz et al. [38]. Note: SICPA: Stanford Inventory of Cancer Patient Adjustment; MSPSS: Multidimensional Scale of Perceived Social Support; MDASI: M.D. Anderson Symptom Inventory; FACT-B: Functional Assessment of Cancer Treatment-B; HADS: Hospital Anxiety and Depression Scale

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