Establishment of electronic patient-reported-outcome symptom monitoring- alerting-intervening (ePRO-SMAI) pathway with metastatic cancer: a protocol for a mixed-design longitudinal cohort study

Abstract

Introduction: Patient-reported outcome (PRO)-based symptom assessment and evaluation of oncological treatment recovery are becoming increasingly important in clinical practice. Although electronic PRO systems are promising, their proactive integration into clinical practice for symptom management remains challenging. Our research aims to establish and explore an electronic PRO-based Symptom Monitoring-Alert-Intervening (ePRO-SMAI) system by emphasizing the importance of comprehensive symptom monitoring in cancer care. Methods and analysis: This mixed-method study integrates qualitative patient input with quantitative data to enhance the ePRO-SMAI pathway for symptom management in patients with metastatic cancer. The study follows a 3-step process: Phase 1 involves a bidirectional cohort study to describe symptom management and assess current models using patient input and expert panels from a hospital in China. This cohort study will enroll 168 patients with pathologically or clinically confirmed advanced malignant tumors. The primary outcome is the symptom burden using PROs and pre-designed at baseline (before treatment of the screen period), then once a week during the first month (weeks 1–4), and once semimonthly after 1 month until admission to the hospital for the next cycle of treatment. Phase 2 focuses on designing, developing, and optimizing a tailored ePRO platform for symptom management. Phase 3 explores the clinical pathways of the ePRO-SMAI system to improve patient care outcomes. Ethics and dissemination: The Ethics Committee of Shaoxing Second Hospital approved this study on August 28, 2023 (No. Shao Er Yi Lun Shen 2023 Yan Di 038), and all methods will carried out in accordance with relevant guidelines and regulations. The manuscript is based on the latest protocol, version 3.0, published on August 15, 2023. Any modification to the protocol will be submitted for subsequent review and approval. Trial registration number ChiCTR2300075430 Trial registration The Chinese Clinical Trial Registry (trial number ChiCTR2300075430) was registered on September 05, 2023 (https//www.chictr.org.cn/).