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ACTIVE NOT RECRUITING
NCT06938945
NA

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

Sponsor: Wei Xiaoping

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2025-05-24

Completion Date

2026-09-01

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

BEHAVIORAL

Digitized patient-reported outcomes

Patients fill out the PRO scale regularly online through a specific cell phone program or website, which intelligently analyzes the patient's physical condition, gives symptom management recommendations (which are based on clinical guidelines and expert consensus, and are updated monthly by oncology clinical experts during the study period), and sends alerts to clinical caregivers when the scale scores are abnormal.

Locations (1)

China Center for Health Development Studies, Peking University

Haidian, Beijing Municipality, China