A self-management application “pain-housekeeper” to control cancer pain: a randomized controlled trial study protocol†

Abstract

Abstract Objective Pain is a prevalent and distressing symptom in patients with cancer which has a significant impact on patients’ physical health, psychological well-being, and quality of life (QOL). Deficiency of pain care, inadequate pain communication, and reluctance toward pain medication contribute to the difficulties in improving the situation of patients with cancer pain. Fortunately, the integration of self-management and professional healthcare provides new opportunities for patients with cancer pain. Methods A two-arm randomized controlled trial will be conducted to assess the effectiveness of self-management application compared with routine care among patients with cancer pain. Based on Orem's self-care theory and Naylor's transitional care theory, cancer pain self-management application “Pain-housekeeper” was developed with dual client: patient client and medical client. A total of 120 patients with cancer pain are recruited from two university-affiliated tertiary public hospitals in China. They are randomly assigned to the control group and the intervention group. The patients in the control group get routine care while the patients in the intervention group get routine care and Pain-housekeeper App. The intervention is delivered by registered doctors, nurses, and postgraduate nursing students specialized in pain care. Effect measurements for both groups are carried out with questionnaires at baseline (T0), after 4 weeks (T1) and after 12 weeks (T2). The primary outcomes include pain condition, self-efficacy, and QOL. The secondary outcomes include pain medication adherence, satisfaction, anxiety, and depression. Compliance of data submission, economic evaluation, usage, and clinical data are also considered in the test. Data for the evaluation are gathered continuously during the study period. Discussion This article provides insight into the effectiveness of a theory-based self-management mobile application intervention delivered to patients with uncontrolled cancer pain. The results are used to help patients to improve cancer pain control, self-efficacy, and QOL. Conclusions The findings of this article provide evidence to support the implementation of an innovative and easily accessible intervention that enhances health outcomes. Trial registration ChiCTR: ChiCTR1800020295, Registered 22 December, 2018.