Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial

BACKGROUND: There are over 2 million newly diagnosed patients with breast cancer worldwide with more than 10,000 cases in Taiwan each year. During 2017-2018, the National Yang-Ming University, the Taiwan University of Science and Technology, and the Taiwan Breast Cancer Prevention Foundation collaborated to develop a breast cancer self-management support (BCSMS) mHealth app for Taiwanese women with breast cancer. OBJECTIVE: The aim of this study was to investigate the quality of life (QoL) of women with breast cancer in Taiwan after using the BCSMS app. METHODS: After receiving a first diagnosis of breast cancer, women with stage 0 to III breast cancer, who were recruited from social networking sites or referred by their oncologists or oncology case managers, were randomized 1:1 into intervention and control groups. Intervention group subjects used the BCSMS app and the control group subjects received usual care. Two questionnaires—the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and the EORTC Breast Cancer-Specific Quality-of-Life Questionnaire (QLQ-BR23)—were distributed to subjects in both arms. Paper-based questionnaires were used at baseline; paper-based or Web-based questionnaires were used at 1.5-month and 3-month follow-up evaluations. All evaluations were self-assessed and anonymous, and participants were blinded to their allocation groups. Descriptive analysis, the Pearson chi-square test, analysis of variance, and the generalized estimating equation were used to analyze the data. Missing values, with and without multi-imputation techniques, were used for sensitivity analysis. RESULTS: A total of 112 women were enrolled and randomly allocated to either the experimental group (n=53) or control group (n=59). The follow-up completion rate was 89.3% (100/112). The demographic data showed homogeneity between the two groups in age (range 50-64 years), breast cancer stage (stage II), marital status (married), working status (employed), and treatment status (receiving treatments). The mean total QoL summary scores from the QLQ-C30 (83.45 vs 82.23, P=.03) and the QLQ-BR23 (65.53 vs 63.13, P=.04) were significantly higher among the experimental group versus the control group, respectively, at 3 months. CONCLUSIONS: This research provides support for using a mobile health care app to promote the QoL among women in Taiwan after a first diagnosis of breast cancer. The BCSMS app could be used to support disease self-management, and further evaluation of whether QoL is sustained is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT004174248; https://clinicaltrials.gov/ct2/show/NCT04174248