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

NCT06938945 | Recruiting

• 1 other identifier: IRB00001052-24066
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Health-Related quality of life

  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 Outcomes (11)

• Change in patient-reported hepatocellular carcinoma symptoms

  Baseline, Week 4 (post-intervention),Week 18(post-intervention)

• Mental health

  Baseline, Week 4 (post-intervention),Week 18(post-intervention)

• Survival period

  Baseline, Week 4 (post-intervention),Week 18(post-intervention)

• Treatment satisfaction

  Baseline, Week 4 (post-intervention),Week 18(post-intervention)

• Treatment compliance

  Baseline, Week 4 (post-intervention),Week 18(post-intervention)

Study Arms (2)

Intervention Group: receive PRO（patient reported outcomes） interventions

EXPERIMENTAL

Behavioral: Digitized patient-reported outcomes

Control Group：usual care (not receive PRO intervention)

NO INTERVENTION

Interventions

Digitized patient-reported outcomes BEHAVIORAL

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.

Intervention Group: receive PRO（patient reported outcomes） interventions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Wei Xiaoping: lead

Study Sites (1)

China Center for Health Development Studies, Peking University

Haidian, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Yiqi Xia

CONTACT

+86 137 2033 7686; 2211110248@stu.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate,China Center for Health Development Studies, Peking University

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 22, 2025
• Study Start: May 24, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations

CN (1)