Effects of Mobile Healthcare Applications on the Lifestyle of Patients With Breast Cancer: A Protocol for a Randomized Clinical Trial

移动医疗应用对乳腺癌患者生活方式的影响:一项随机临床试验方案

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Abstract

PURPOSE: Physical activity (PA) in patients with breast cancer is associated with improved quality of life (QoL); however, many breast cancer survivors do not meet the recommended PA level. This study aims to evaluate the effect of digital health interventions using mobile apps to promote PA and QoL in patients with postoperative breast cancer. This study will also identify effective digital intervention methods and perform an economic analysis. The main hypothesis is that the use of mobile healthcare apps will improve health-related quality of life (HRQOL), promote PA, and reduce healthcare costs. METHODS: The Promotion of a better lifestyle (PA) with Precise and Practicable digital healthcare in postoperative CANCER patients through a Multi-Disciplinary Network (P4CancerMDnet) study is examined by a prospective 4-group randomized controlled trial with a concurrent cost-utility evaluation. Patients are randomly assigned to 3 different mobile app intervention groups or control groups in a 1:1:1:1 ratio. The intervention group is encouraged to use the assigned mobile app. The targeted outcomes are HRQOL, metabolic health markers, and quality-adjusted life-years. The outcomes will be measured at the 6- and 12-month follow-ups. DISCUSSION: This study will contribute towards a better lifestyle and HRQOL through digital healthcare for postoperative breast cancer patients. These findings are expected to provide evidence of the effectiveness of mobile apps for breast cancer survivors. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0005447.

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