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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group: receive PRO（patient reported outcomes） interventions | Experimental |
| |
| Control Group：usual care (not receive PRO intervention) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4 (post-intervention),Week 18(post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-reported hepatocellular carcinoma symptoms | PRO questionnaire | 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. |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiqi Xia | Contact | +86 137 2033 7686 | 2211110248@stu.pku.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Center for Health Development Studies, Peking University | Recruiting | Haidian | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114858 | Derived | 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. |
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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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| Baseline, Week 4 (post-intervention),Week 18(post-intervention) |
| Survival period | Baseline, Week 4 (post-intervention),Week 18(post-intervention) |
| Treatment satisfaction | PRO questionnaire | 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. | 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 | Baseline, Week 4 (post-intervention),Week 18(post-intervention) |
| The number of visits to the outpatient department, inpatient department and emergency department | PRO questionnaire | Baseline, Week 4 (post-intervention),Week 18(post-intervention) |
| Direct medical costs | Baseline, Week 4 (post-intervention),Week 18(post-intervention) |
| Direct non-medical costs | Baseline, Week 4 (post-intervention),Week 18(post-intervention) |
| Indirect cost | 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. | Baseline, Week 4 (post-intervention),Week 18(post-intervention) |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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