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

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

Recruiting
18-75 years
All
Phase N/A

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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.

Eligibility

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 details
    Hepatocellular Carcinoma (HCC)

NCT06938945

Wei Xiaoping

13 May 2026

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Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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