An Oncology Nurse Artificial Intelligence Agent to Reduce Cancer Distress of Patients Undergoing Radiotherapy: A Mixed-Methods Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- National Comprehensive Cancer Network Distress Thermometer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •insufficient command of Chinese
- •have any other factors precluding the ability to give informed consent or comply with the protocol
研究组 & 干预措施
Treatment-As-Usual Arm
Participants in the Treatment-As-Usual group will receive routine onsite nursing care in which the nurse discusses general knowledge of self-care behaviors regarding the management of radiotherapy-related side effects.
Digi-Coach Chatbot Arm
Participants in Digi-Coach Chatbot Arm will have access to the Digi-Coach chatbot in addition to usual care. The research nurse will provide training on how to use the chatbot.
干预措施: Digi-Coach Chatbot (Other)
结局指标
主要结局
National Comprehensive Cancer Network Distress Thermometer
时间窗: 1 week, 8 weeks, and 12 weeks
A 2-item measurement that has participants first rate their distress levels on a scale of 0 (no distress) to 10 (extreme distress) and then self-report their concerns by choosing from a given list of physical, emotional, social, practical, spiritual, or other concerns.
次要结局
- Memorial Symptom Assessment Scale(1 week, 8 weeks, and 12 weeks)
- Functional Assessment of Cancer Therapy-Head and Neck(1 week, 8 weeks, and 12 weeks)
研究者
Tongyao WANG
Research Assitant Professor
The University of Hong Kong