AI-Assisted Whole-Course Management for Medication Safety and Healthcare Burden in Advanced Solid Tumors: A Prospective Controlled Study
AI Agent-Enabled Whole-Course Management to Improve Anticancer Medication Safety and Reduce Healthcare Burden in Advanced Solid Tumors: A Prospective, Single-Center, Non-Randomized, Parallel-Group Real-World Controlled Study
This is a prospective, single-center, controlled real-world study in patients with advanced solid tumors (stage III-IV) receiving chemotherapy, targeted therapy, immunotherapy, or endocrine therapy. Participants who choose the digital management group use a smartphone-based oncology management application with medication reminders, AI-assisted laboratory report interpretation, adverse event self-reporting, and clinician alerts for critical values. Participants who choose the conventional group receive routine outpatient follow-up and telephone contact without digital tools. The study follows participants for 12 months to compare the incidence of overall and severe (CTCAE grade ≥3) adverse events, emergency department visits, 30-day readmission, dose reduction, treatment delay/missed doses, and time to adverse event recovery. The aim is to evaluate whether a digital whole-course management model improves medication safety, reduces healthcare burden, and supports treatment adherence in advanced cancer care.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Haitao Wang, Ph.D
- Номер телефона: +86-022-88321190
- Электронная почта: peterrock2000@126.com
Учебное резервное копирование контактов
- Имя: Lili Wang, Ph.D
- Номер телефона: +86-022-88321185
- Электронная почта: wangliliaigang@163.com
Места учебы
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Китай, 300211
- Рекрутинг
- Tianjin Medical Unversity Second Hospital
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Младший исследователь:
- Dingkun Hou, Ph.D
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Младший исследователь:
- Jinhuan Wang, Ph.D
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Младший исследователь:
- Lili Wang, Ph.D
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Контакт:
- Haitao Wang, Ph.D
- Номер телефона: +86-022-88321190
- Электронная почта: peterrock2000@126.com
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Младший исследователь:
- Hongzheng Li, M.M.
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Контакт:
- Lili Wang, Ph.D
- Номер телефона: +86-022-88321185
- Электронная почта: wangliliaigang@163.com
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Главный следователь:
- Haitao Wang, Ph.D
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Tianjin, Tianjin Municipality, Китай
- Рекрутинг
- Department of Oncology, Tianjin Medical University Second Hospital
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Контакт:
- Lili Wang, Ph.D
- Номер телефона: +86-022-88321185
- Электронная почта: wangliliaigang@163.com
-
Контакт:
- Haitao Wang, Ph.D
- Электронная почта: wanght@tmu.edu.cn
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Histologically or cytologically confirmed malignant tumor, scheduled to receive or currently receiving systemic anticancer therapy (chemotherapy, targeted therapy, immunotherapy, or endocrine therapy).
- Age ≥18 years.
- For the digital management group: able to independently use a smartphone to scan a QR code to log in, photograph and upload laboratory reports, and complete online forms; for the control group: able to communicate by telephone and attend outpatient visits.
- Expected survival ≥12 months.
- Able to understand the study and provide written informed consent.
- Receiving regular home oral or cyclic intravenous anticancer treatment and requiring long-term out-of-hospital follow-up.
- Able to complete 12 months of follow-up.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Severe cognitive impairment or severe psychiatric illness precluding independent follow-up or causing extremely poor adherence.
- End-stage multi-organ failure or moribund condition with expected survival <12 months.
- Receiving only palliative supportive care, with no planned standard anticancer drug treatment.
- Other conditions judged by the investigator as unsuitable for this study.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Digital Management Group
Participants use a smartphone-based oncology management app for the entire 12-month follow-up: medication check-in with missed-dose reminders; photo upload and AI-assisted interpretation of laboratory reports with critical-value alerts to clinicians; CTCAE 5.0-based adverse event self-reporting with severity-triggered clinician notification; monthly online follow-up questionnaires; and a dedicated module for clinical trial participants. |
A self-developed application integrating medication adherence reminders, AI-assisted laboratory interpretation, adverse event self-reporting, critical-value clinician alerts, monthly electronic follow-up, and clinical trial participant tracking. |
|
Активный компаратор: Conventional Follow-up Group
Participants receive routine outpatient follow-up and intermittent telephone contact per standard departmental practice. No digital reminders, no AI-assisted laboratory interpretation, no home-based adverse event self-reporting, and no real-time critical-value alerts. |
The conventional management group reflects routine departmental practice: outpatient appointment-based follow-up, unstructured telephone follow-up, offline review of outside laboratory reports, passive reporting of adverse events at clinic visits or emergency department presentations, and no digital medication adherence reminders or real-time clinician alerts. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of any-grade adverse events
Временное ограничение: Within 24 months of enrollment.
|
Proportion of participants experiencing any antineoplastic-related adverse event, graded by NCI CTCAE 5.0. |
Within 24 months of enrollment.
|
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Incidence of severe adverse events (CTCAE grade ≥3)
Временное ограничение: Within 24 months of enrollment
|
Proportion of participants experiencing grade ≥3 bone marrow suppression, gastrointestinal events, rash, liver injury, or other CTCAE grade ≥3 events. |
Within 24 months of enrollment
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Emergency department visit rate due to anticancer treatment-related adverse events
Временное ограничение: 12 months after enrollment
|
Proportion of participants with at least one emergency department visit due to an anticancer treatment-related adverse event during follow-up. Data source: medical records and participant-reported events confirmed by the study site. |
12 months after enrollment
|
|
30-day readmission rate related to anticancer treatment-related adverse events
Временное ограничение: 12 months after enrollment; each readmission assessed within 30 days after discharge
|
Among participants with at least one hospitalization related to an anticancer treatment-related adverse event, proportion readmitted within 30 days after discharge. Each discharge is followed for 30 days. |
12 months after enrollment; each readmission assessed within 30 days after discharge
|
|
Incidence of anticancer drug dose reduction due to adverse events
Временное ограничение: 12 months after enrollment
|
Proportion of participants requiring at least one reduction in anticancer drug dose due to an adverse event, as documented in the medical record. |
12 months after enrollment
|
|
Incidence of treatment delay due to adverse events
Временное ограничение: 12 months after enrollment
|
Proportion of participants with at least one anticancer treatment cycle delayed or temporarily interrupted due to an adverse event. |
12 months after enrollment
|
|
Incidence of missed anticancer doses
Временное ограничение: 12 months after enrollment
|
Among participants receiving oral anticancer therapy, proportion with at least one missed dose during follow-up, based on app check-in records (intervention group) or self-report/outpatient records (control group). |
12 months after enrollment
|
|
Median time to adverse event recovery
Временное ограничение: From adverse event onset to recovery, assessed up to 12 months after enrollment
|
Median time from onset of an eligible adverse event to recovery of symptoms and/or laboratory abnormality to baseline or CTCAE grade ≤1, estimated using Kaplan-Meier methods. Adverse events are graded by NCI CTCAE 5.0. |
From adverse event onset to recovery, assessed up to 12 months after enrollment
|
|
Monthly mean number of missed oral anticancer doses
Временное ограничение: Monthly for 12 months after enrollment
|
Mean number of missed oral anticancer doses per participant per month, calculated from app check-in records (intervention group) or self-report/outpatient records (control group). |
Monthly for 12 months after enrollment
|
|
Protocol adherence rate among clinical trial participants (exploratory)
Временное ограничение: 12 months after enrollment
|
Among participants concurrently enrolled in a clinical trial, proportion who complete protocol-specified treatment cycles and scheduled assessments without major protocol deviation, as documented by the site. |
12 months after enrollment
|
|
Protocol deviation incidence among clinical trial participants (exploratory)
Временное ограничение: 12 months after enrollment
|
Among participants concurrently enrolled in a clinical trial, proportion with at least one protocol deviation, classified by type and relationship to the digital management intervention. |
12 months after enrollment
|
Соавторы и исследователи
Следователи
- Главный следователь: Haitao Wang, Ph.D, Tianjin Medical University Second Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- AIM-SAFE
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The study protocol does not include a pre-specified plan or dedicated funding for sharing individual participant data with external researchers. Data will be maintained by the sponsor and participating sites in accordance with the approved informed consent and local regulatory requirements. This statement may be updated if a data sharing plan is established at a later stage.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .