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

April 6, 2026 updated by: Wei Xiaoping

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Haidian, Beijing Municipality, China, 100191
        • Recruiting
        • China Center for Health Development Studies, Peking University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

The inclusion criteria for the participants are: (1) aged 18 to 75 years, (2) clinically diagnosed as HCC, (3) treated with immunotherapy, (4) able and willing to use smartphones or tablets to complete the follow-up process according to protocol and (5) can understand Mandarin Chinese.

The exclusion criteria are: (1) cognitive deficits that would preclude recognizing of their own symptoms and feelings, (2) unable to understand the research content and/or questionnaires, (3) is going to take or having taken surgical resection or liver transplant, (4) currently participating in other clinical trials that may affect this study, or (5) having other malignant tumours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group: receive PRO（patient reported outcomes） 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.
No Intervention: Control Group：usual care (not receive PRO intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related quality of life
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

EORTC QLQ-C30 Quality of Life Scale(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Baseline, Week 4 (post-intervention),Week 18(post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-reported hepatocellular carcinoma symptoms
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
PRO questionnaire
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Mental health
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
PHQ-9 Scale((Patient Health Questionnaire-9) The total score can range from 0 to 27. Higher scores indicate greater severity of depression.
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Survival period
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Treatment satisfaction
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
PRO questionnaire
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Treatment compliance
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
The Morisky Medication Adherence Scale (MMAS-8) The total score of the MMAS-8 scale is the sum of the scores of 8 questions. The score range is 0 to 8 points. The higher the score, the better the medication compliance. A score of 8 indicates good compliance; A score of 6 to 7 indicates moderate compliance. A score less than 6 indicates poor compliance.
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
The number of times the official account functions are used
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
The native statistics system of the WeChat Official Account backend
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
The number of visits to the outpatient department, inpatient department and emergency department
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
PRO questionnaire
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Direct medical costs
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Direct non-medical costs
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Indirect cost
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Health State Utility
Time Frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
EuroQol 5-Dimension 5-Level (EQ-5D-5L) The scale measures quality of life on a 5-component scale.For each dimension, based on the level selected by the respondents, the score for that level is given respectively, with the highest being 5 points and the lowest being 1 point. Then add up the scores of all dimensions to obtain the score of the entire rating scale, with a maximum of 25 points and a minimum of 5 points.The higher the score, the lower the health state utility.
Baseline, Week 4 (post-intervention),Week 18(post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Xiaoping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00001052-24066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant-level data underlying the published results will be made available upon reasonable request, subject to institutional review and data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma (HCC)

Clinical Trials on Digitized patient-reported outcomes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe