Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06938945

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Center for Health Development Studies, Peking University

Haidian, Beijing Municipality, 100191, China

Location status: Recruiting

Location contact

Yiqi Xia

CONTACT

[email protected]

+86 137 2033 7686

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Health-Related quality of life

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

    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.

Secondary outcomes

  1. Change in patient-reported hepatocellular carcinoma symptoms

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

    PRO questionnaire

  2. Mental health

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

    PHQ-9 Scale((Patient Health Questionnaire-9) The total score can range from 0 to 27. Higher scores indicate greater severity of depression.

  3. Survival period

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

  4. Treatment satisfaction

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

    PRO questionnaire

  5. Treatment compliance

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

    The Morisky Medication Adherence Scale (MMAS-8) The total score of the MMAS-8 scale is the sum of the scores of 8 questions. The score range is 0 to 8 points. The higher the score, the better the medication compliance. A score of 8 indicates good compliance; A score of 6 to 7 indicates moderate compliance. A score less than 6 indicates poor compliance.

  6. The number of times the official account functions are used

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

    The native statistics system of the WeChat Official Account backend

  7. The number of visits to the outpatient department, inpatient department and emergency department

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

    PRO questionnaire

  8. Direct medical costs

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

  9. Direct non-medical costs

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

  10. Indirect cost

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

  11. Health State Utility

    Time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)

    EuroQol 5-Dimension 5-Level (EQ-5D-5L) The scale measures quality of life on a 5-component scale.For each dimension, based on the level selected by the respondents, the score for that level is given respectively, with the highest being 5 points and the lowest being 1 point. Then add up the scores of all dimensions to obtain the score of the entire rating scale, with a maximum of 25 points and a minimum of 5 points.The higher the score, the lower the health state utility.

Study contacts

Contact information is provided by the study sponsor or research team.

Yiqi Xia

CONTACT

[email protected]

+86 137 2033 7686

Sponsors and collaborators

Lead sponsor

Wei Xiaoping

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.