Evidence map›Paper›PMID 42114858›Full record

ArticleBMJ open2026

Electronic symptom monitoring of patient-reported outcomes among patients with hepatocellular carcinoma during immunotherapy (PRIME-HCC): protocol for a randomised controlled trial.

Yiqi Xia, Xiaoping Wei, Yanshang Wang, Zhenyu Shi, Ping He

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06938945 (Electronic Symptom Monitoring of Patient-Reported Outcomes Among Patients With Hepatocellular Carcinoma During Immunotherapy), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06938945 narecruitingnot on this map

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

TypeinterventionalSponsorWei XiaopingRan2025 to 2026Enrolled500ConditionsHepatocellular Carcinoma (HCC)ArmsDigitized patient-reported outcomes
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Yiqi XiaChina Center for Health Development Studies, Peking University, Beijing, China.
Xiaoping WeiChina Center for Health Development Studies, Peking University, Beijing, China.
Yanshang WangDivision of Psychiatry, Faculty of Brain Science, University College London, London, UK.
Zhenyu ShiSchool of Social Development and Health Management, University of Health and Rehabilitation Sciences Qingdao Hospital, Qingdao, China.
Ping HeChina Center for Health Development Studies, Peking University, Beijing, China phe@pku.edu.cn.ORCID http://orcid.org/0000-0001-5040-5012

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionElectronic patient-reported outcome (ePROs)-based symptom monitoring benefits health-related quality of life (HRQoL) in various cancers. However, despite the high disease and economic burden of hepatocellular carcinoma (HCC) and the complex symptom profile during immunotherapy, the effectiveness and implementation of ePROs-based interventions in this population remain unclear. This study aims to evaluate the clinical and implementation outcomes of ePROs-based symptom monitoring among patients with HCC receiving immunotherapy in China. METHODS AND ANALYSIS: The trial is a two-arm randomised controlled trial (RCT). Approximately 238 patients with HCC undergoing immunotherapy in China will be recruited and randomly assigned (1:1) to an intervention or control group. The intervention group will receive an 18 week, weekly ePROs symptom monitoring survey via a WeChat-based platform, featuring reactive alerts that provide patients with automated, evidence-based self-management advice when predefined thresholds are exceeded. The control group will receive usual care. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) Framework and normalisation process theory (NPT), the study employs a mixed-methods approach. The primary outcome is the between-group difference in HRQoL at 18 weeks. Secondary effectiveness outcomes include physical function, symptom burden, overall survival, mental health and healthcare utilisation. Key implementation outcomes, assessed quantitatively and qualitatively, include acceptability, feasibility, fidelity, cost-effectiveness and the contextual mechanisms influencing sustainability and scalability. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Review Board of Peking University (IRB No. 00001052-24066). This protocol is based on V2.0, 6 July 2024 of the protocol. Electronic informed consent is obtained from all participants. Findings will be disseminated through peer-reviewed publications and academic conferences, providing evidence to inform scalable integration of digital symptom monitoring into oncology care. TRIAL REGISTRATION NUMBER: NCT06938945.

Indexed as

Carcinoma, HepatocellularImmunotherapyLiver NeoplasmsPatient Reported Outcome MeasuresChinaFemaleHumansMaleQuality of LifeRandomized Controlled Trials as TopicRemote Patient MonitoringCarcinoma, HepatocellularImplementation SciencePatient Reported Outcome MeasuresRandomized Controlled Trial

Identifiers

PMID42114858
PMCPMC13182307

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.