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Идёт набор NCT06938945

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

Без фазы С лечением Hepatocellular Carcinoma (HCC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Digitized patient-reported outcomes.
Кому может быть актуально
Состояния в реестре: Hepatocellular Carcinoma (HCC). Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Поведенческое Digitized patient-reported outcomes
    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.

Первичные конечные точки

  • Health-Related quality of life [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
Вторичные конечные точки (11)
  • Change in patient-reported hepatocellular carcinoma symptoms [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • Mental health [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • Survival period [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • Treatment satisfaction [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • Treatment compliance [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • The number of times the official account functions are used [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • The number of visits to the outpatient department, inpatient department and emergency department [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • Direct medical costs [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • Direct non-medical costs [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • Indirect cost [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]
  • Health State Utility [Срок оценки: Baseline, Week 4 (post-intervention),Week 18(post-intervention)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • China Center for Health Development Studies, Peking University — Haidian

Публикации

  • 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. PMID 42114858

Идентификаторы

NCT: NCT06938945 · IRB00001052-24066

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗