临床试验/NCT06938945

NCT06938945招募中不适用

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

Wei Xiaoping1 个研究点分布在 1 个国家目标入组 500 人开始时间: 2025年5月24日最近更新: 2026年4月13日

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 500
试验地点: 1
主要终点: Health-Related quality of life

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

Intervention Group: receive PRO（patient reported outcomes） interventions

Experimental

干预措施: Digitized patient-reported outcomes (Behavioral)

Control Group：usual care (not receive PRO intervention)

No Intervention

结局指标

主要结局

Health-Related quality of life

时间窗: 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.

次要结局

Change in patient-reported hepatocellular carcinoma symptoms(Baseline, Week 4 (post-intervention),Week 18(post-intervention))
Mental health(Baseline, Week 4 (post-intervention),Week 18(post-intervention))
Survival period(Baseline, Week 4 (post-intervention),Week 18(post-intervention))
Treatment satisfaction(Baseline, Week 4 (post-intervention),Week 18(post-intervention))
Treatment compliance(Baseline, Week 4 (post-intervention),Week 18(post-intervention))
The number of times the official account functions are used(Baseline, Week 4 (post-intervention),Week 18(post-intervention))
The number of visits to the outpatient department, inpatient department and emergency department(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(Baseline, Week 4 (post-intervention),Week 18(post-intervention))

研究者

发起方

Wei Xiaoping

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Wei Xiaoping

PhD Candidate,China Center for Health Development Studies, Peking University

Peking University

研究点 (1)

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