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Идёт набор NCT06636188

An Oncology Nurse AI Agent to Reduce Cancer Distress During Radiotherapy

Без фазы С лечением Head and Neck Cancer

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: Digi-Coach Chatbot.
Кому может быть актуально
Состояния в реестре: Head and Neck Cancer. Базовые параметры: от 18 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

An Oncology Nurse Artificial Intelligence Agent to Reduce Cancer Distress of Patients Undergoing Radiotherapy: A Mixed-Methods Randomized Controlled Trial

Обзор

The goal of this clinical trial is to assess the effectiveness of the Digi-Coach chatbot for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer. The main question it aims to answer is: How effective is the Digi-Coach chatbot in reducing physical and psychological distress? Researchers will compare Digi-Coach chatbot to usual nursing care to see if Digi-Coach chatbot is effective for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer. Participants will have access to the Digi-Coach chatbot during radiotherapy in addition to usual care. The research nurse will provide training on how to navigate the chatbot and ask participants to query all their cancer-related concerns in the chatbot.

Подробное описание

The goal of this clinical trial is to assess the effectiveness of the Digi-Coach chatbot for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

The main question it aims to answer is: How effective is the Digi-Coach chatbot in reducing physical and psychological distress? Researchers will compare Digi-Coach chatbot to usual nursing care to see if Digi-Coach chatbot is effective for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

A single-blinded parallel randomized controlled trial (RCT allocation ratio = 1:1) will be conducted, with baseline data collection at week 1 (T0) and three follow-up timepoints at week 8 (T1), week 12 (T2) following radiotherapy commencement.

Participants in the Treatment-As-Usual group will receive routine onsite nursing care in which the nurse discussed general knowledge of self-care behaviors regarding the management of radiotherapy-related side effects.

Participants in the intervention group will have access to the Digi-Coach chatbot in addition to usual care. The research nurse will provide training on how to navigate the chatbot and ask participants to query all their cancer-related concerns in the chatbot.

Вмешательства

  • Другое Digi-Coach Chatbot
    Participants will have access to the Digi-Coach chatbot in addition to usual care. The research nurse will provide training on how to navigate the chatbot and ask participants to query all their cancer related concerns in the chatbot.

Первичные конечные точки

  • National Comprehensive Cancer Network Distress Thermometer [Срок оценки: 1 week, 8 weeks, and 12 weeks]
Вторичные конечные точки (2)
  • Memorial Symptom Assessment Scale [Срок оценки: 1 week, 8 weeks, and 12 weeks]
  • Functional Assessment of Cancer Therapy-Head and Neck [Срок оценки: 1 week, 8 weeks, and 12 weeks]

Критерии участия

Критерии включения

  • aged 18 and above
  • are able to read and speak Cantonese or Mandarin fluently
  • have a new, primary diagnosis of head and neck/laryngeal cancer
  • are waiting to receive a full course of curative-intent, external beam radiotherapy with or without chemotherapy
  • have a Karnofsky performance score ≥70
  • have distress scored 3 or above on the NCCN distress thermometer

Критерии исключения

  • insufficient command of Chinese
  • have any other factors precluding the ability to give informed consent or comply with the protocol

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

Гонконг · 2 центра
  • The University of Hong Kong — Гонконг
  • Queen Mary Hospital — Гонконг

Идентификаторы

NCT: NCT06636188 · KC/KE-23-0116/ER-4

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗