NCT06938945Recruiting
Electronic Symptom Monitoring of Patient-Reported Outcomes Among Patients With Hepatocellular Carcinoma During Immunotherapy (PRIME-HCC): Protocol for a Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 24 May 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Wei Xiaoping
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06938945
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 24 May 2025 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China Center for Health Development Studies, Peking University Coordinator of this site? Confirm its status | Haidian | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.