Hepatocellular Carcinoma (HCC)NCT06938945
Electronic Symptom Monitoring of Patient-Reported Outcomes Among Patients With Hepatocellular Carcinoma During Immunotherapy (PRIME-HCC): Protocol for a Randomised Controlled Trial
A study testing Digitized patient-reported outcomes in people with Hepatocellular Carcinoma (HCC), run by Wei Xiaoping at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Digitized patient-reported outcomes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China Center for Health Development Studies, Peking University
Haidian, Beijing Municipality, 100191
Yiqi Xia, +86 137 2033 7686, 2211110248@stu.pku.edu.cn
About this study
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.
Read more
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Digitized patient-reported outcomes
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitized patient-reported outcomesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: receive PRO（patient reported outcomes） interventions | Experimental | Not described Receives: Behavioral: Digitized patient-reported outcomes |
| Control Group：usual care (not receive PRO intervention) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related quality of life
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.
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Secondary outcomes (11)
Change in patient-reported hepatocellular carcinoma symptoms
PRO questionnaire
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Mental health
PHQ-9 Scale((Patient Health Questionnaire-9) The total score can range from 0 to 27. Higher scores indicate greater severity of depression.
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Survival period
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Treatment satisfaction
PRO questionnaire
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Treatment compliance
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.
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
The number of times the official account functions are used
The native statistics system of the WeChat Official Account backend
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
The number of visits to the outpatient department, inpatient department and emergency department
PRO questionnaire
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Direct medical costs
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Direct non-medical costs
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Indirect cost
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Health State Utility
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.
Measured: Baseline, Week 4 (post-intervention),Week 18(post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start24 May 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Xiaoping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Xiaoping, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938945
- Sponsor's protocol ID
- IRB00001052-24066
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data underlying the published results will be made available upon reasonable request, subject to institutional review and data use agreement.
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.
PubMed 42114858
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Symptom Monitoring of Patient-Reported Outcomes Among Patients With Hepatocellular Carcinoma During Immunotherapy (PRIME-HCC): Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06938945
- Acronym / sponsor ID
- IRB00001052-24066
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wei XiaopingUniversity, hospital or other
- Study start
- 24 May 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: receive PRO（patient reported outcomes） interventions | Experimental | Behavioral: Digitized patient-reported outcomes |
| Control Group：usual care (not receive PRO intervention) | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitized patient-reported outcomesPatients 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. | Behavioural | Intervention Group: receive PRO（patient reported outcomes） interventions |
Primary outcome
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.
11 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42114858Xia 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.
- Individual participant dataSharing planned: Yes. De-identified participant-level data underlying the published results will be made available upon reasonable request, subject to institutional review and data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitized patient-reported outcomes in people with Hepatocellular Carcinoma (HCC), run by Wei Xiaoping at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiqi Xia (+86 137 2033 7686, 2211110248@stu.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related quality of life (time frame: Baseline, Week 4 (post-intervention),Week 18(post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06938945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.