Information-providing Chatbot

Официальное название

The Development and Evaluation of a Co-designed, AI-based Information-providing Chatbot for Sarcoma Patients: A Pilot Randomised Controlled Trial

Обзор

This study aims to develop and examine the feasibility and preliminary effectiveness of an AI-based sarcoma chatbot building on ChatGPT (ASCC) to address the information needs of sarcoma patients. We hypothesized: 1) the ASCC will demonstrate good usability; 2) the study will be feasible in terms of all feasibility indicators; 3) the experimental group will report improved satisfaction and self-efficacy, decreased anxiety and stress than the control groups upon completion of the intervention. The ASCC will be developed using a co-design approach. A pilot randomized controlled trial will then be conducted in the three oncology wards of collaborative hospitals. Seventy-eight sarcoma patients will be recruited and randomized to the experimental group (n=39) and the control group (n=39). The experimental group will use the ASCC available 24/7 via voice or text for disease-related questions for one month while the control group will receive usual care.

Вмешательства

• Другое ASCC (sarcoma-specific AI chatbot)
  The participants in the experimental group will access the ASCC via a webpage alongside standard information from health professionals for one month (15 minutes weekly).
• Другое Routine Clinical Care
  Participants in the control group will receive routine clinical care, including standard information from doctor-patient consultations (e.g., diagnosis, treatment, medical tests) and hospital provided sarcoma and treatment leaflet.

Первичные конечные точки

• Screening rate [Срок оценки: During the enrollment period of this project.]
• Eligibility rate [Срок оценки: During the enrollment period of this project.]
• Consent rate [Срок оценки: During the enrollment period of this project.]
• Randomization rate [Срок оценки: During the enrollment period of this project.]
• Attendance rate [Срок оценки: Baseline and immediately after intervention (T1)]
• Retention rate [Срок оценки: Baseline and immediately after intervention (T1)]
• Completion rate [Срок оценки: Baseline and immediately after intervention (T1)]
• Proportion of missing data [Срок оценки: Baseline and immediately after intervention (T1)]
• Adverse events [Срок оценки: immediately after intervention (T1)]

Вторичные конечные точки (4)

• Information satisfaction [Срок оценки: Baseline and immediately after intervention (T1)]
• Anxiety and stress [Срок оценки: Baseline and immediately after intervention (T1)]
• Self-efficacy [Срок оценки: Baseline and immediately after intervention (T1)]
• System Usability Scale [Срок оценки: immediately after intervention (T1)]

Критерии участия

Критерии включения

• (1) diagnosed with soft tissue sarcoma;
• (2) receiving active treatment at any stage;
• (3) aged≥18 years;
• (4) able to speak Cantonese, Mandarin and English;
• (5) access to an electronic device enabling ASCC use

Критерии исключения

• (1) patients with unstable physical or mental conditions;
• (2) inability to communicate logically;
• (3) using chatbots (e.g., ChatGPT, Deepseek) for sarcoma information in the last month;
• (4) mental health disorders documented by the medical system

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07505732 · ASCC Intervention

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗