Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06938945

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

Led by Wei Xiaoping · Updated on 2026-04-13

500

Participants Needed

1

Research Sites

66 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years
  • Clinically diagnosed with hepatocellular carcinoma
  • Receiving immunotherapy treatment
  • Able and willing to use smartphones or tablets to complete follow-up as required
  • Understands Mandarin Chinese
Not Eligible

You will not qualify if you...

  • Cognitive deficits preventing recognition of own symptoms and feelings
  • Unable to understand the research content or questionnaires
  • Scheduled for or having received surgical resection or liver transplant
  • Currently participating in other clinical trials that may affect this study
  • Having other malignant tumors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

China Center for Health Development Studies, Peking University

Haidian, Beijing Municipality, China, 100191

Actively Recruiting

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Research Team

Y

Yiqi Xia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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