Clinical Trial Protocol: Randomized Controlled Trial of Cancer Pain Monitoring System (CAPAMOS) in Patients with Advanced Cancer

摘要

Purpose: This randomized controlled trial (RCT) protocol was designed to evaluate the effectiveness of the Cancer Pain Monitoring System (CAPAMOS), a telenursing system designed to alleviate pain in ambulatory patients with advanced cancer. Methods: The study design involved a randomized controlled trial consisting of an intervention group using CAPAMOS and a control group that received usual care. At the time of enrollment, both groups will be given a questionnaire regarding issues, such as concerns related to cancer pain and self-management of opioid medication. Patients will then receive pain relief education based on the results of the questionnaire. Subjects in the control group will receive a pain diary and pain-relief pamphlet that acts as an educational tool. They could also call the outpatient clinic if they wanted to ask for a nursing consultation. The intervention group will be able to use CAPAMOS to manage their pain and receive video consultation with a telenurse, who is an oncology nursing specialist. Educational tools will be built into CAPAMOS. The study will be conducted for one month. The primary endpoint of this study was to calculate the Japanese Brief Pain Inventory score. The secondary endpoints were to assess the opioid medication self-management, Barriers Questionnaire, Japanese EuroQol 5-dimensions 5-level, and economic evaluation. Assessment items will be evaluated at registration and 2 and 4 weeks after registration. Conclusions: A RCT based on this protocol is expected to validate the efficacy of telenursing using CAPAMOS in patients with advanced cancer and pain.