Clinical Trial

Electronic Symptom Monitoring of Patient-Reported Outcomes Among Patients With Hepatocellular Carcinoma During Immunotherapy (PRIME-HCC): Protocol for a Randomised Controlled Trial

Recruiting
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Summary
The goal of this clinical trial is to design a digital PRO intervention model applicable to patients with hepatocellular carcinoma, and The main questions it aims to answer are: * Can symptom management through patients' regular completion of the PRO scale promote self-understanding, self-management and timely seeking of medical help, enable healthcare professionals to accurately and efficiently understand how patients really feel and respond in a timely manner, and ultimately improve health outcomes? * Can digital interventions significantly improve outcomes such as symptom control and quality of life in cancer patients? Researchers divided participants into an intervention group and a control group and compared them to see if digital interventions could improve patient health outcomes. Participants will: * Subjects in the intervention group will be asked to report symptom information weekly (7-day natural week, hereafter) via the public number, and the back office will give symptom management advice or issue alerts based on the filling. Control subjects will not receive PRO intervention. * Participants can offer to withdraw from the study at any time.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Recruiting 2026-04-14
Trial Details
NCT Number NCT06938945
Lead Sponsor Wei Xiaoping
Conditions Hepatocellular Carcinoma (HCC)
Enrollment 500 participants
Start Date 2025-05-24
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-13