Electronic symptom monitoring of patient-reported outcomes among patients with hepatocellular carcinoma during immunotherapy (PRIME-HCC): protocol for a randomised controlled trial

Introduction Electronic patient-reported outcome (ePROs)-based symptom monitoring benefits health-related quality of life (HRQoL) in various cancers. However, despite the high disease and economic burden of hepatocellular carcinoma (HCC) and the complex symptom profile during immunotherapy, the effectiveness and implementation of ePROs-based interventions in this population remain unclear. This study aims to evaluate the clinical and implementation outcomes of ePROs-based symptom monitoring among patients with HCC receiving immunotherapy in China. Methods and analysis The trial is a two-arm randomised controlled trial (RCT). Approximately 238 patients with HCC undergoing immunotherapy in China will be recruited and randomly assigned (1:1) to an intervention or control group. The intervention group will receive an 18 week, weekly ePROs symptom monitoring survey via a WeChat-based platform, featuring reactive alerts that provide patients with automated, evidence-based self-management advice when predefined thresholds are exceeded. The control group will receive usual care. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) Framework and normalisation process theory (NPT), the study employs a mixed-methods approach. The primary outcome is the between-group difference in HRQoL at 18 weeks. Secondary effectiveness outcomes include physical function, symptom burden, overall survival, mental health and healthcare utilisation. Key implementation outcomes, assessed quantitatively and qualitatively, include acceptability, feasibility, fidelity, cost-effectiveness and the contextual mechanisms influencing sustainability and scalability. Ethics and dissemination The study has been approved by the Institutional Review Board of Peking University (IRB No. 00001052-24066). This protocol is based on V2.0, 6 July 2024 of the protocol. Electronic informed consent is obtained from all participants. Findings will be disseminated through peer-reviewed publications and academic conferences, providing evidence to inform scalable integration of digital symptom monitoring into oncology care. Trial registration number NCT06938945 .