Electronic Symptom Monitoring of Patient-Reported Outcomes Among Patients With Hepatocellular Carcinoma During Immunotherapy (PRIME-HCC): Protocol for a Randomised Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digitized patient-reported outcomes.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Health-Related quality of life [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
Secondary outcome measures (11)
- Change in patient-reported hepatocellular carcinoma symptoms [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
- Mental health [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
- Survival period [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
- Treatment satisfaction [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
- Treatment compliance [Time frame: 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 number of visits to the outpatient department, inpatient department and emergency department [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
- Direct medical costs [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
- Direct non-medical costs [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
- Indirect cost [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
- Health State Utility [Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- China Center for Health Development Studies, Peking University — Haidian
Publications
- Xia Y, Wei X, Wang Y, Shi Z, He P. Electronic symptom monitoring of patient-reported outcomes among patients with hepatocellular carcinoma during immunotherapy (PRIME-HCC): protocol for a randomised controlled trial. BMJ Open. 2026 May 11;16(5):e116199. doi: 10.1136/bmjopen-2026-116199. PMID 42114858
Identifiers
NCT: NCT06938945 · IRB00001052-24066