AI chat support for anxiety in men newly diagnosed with metastatic prostate cancer
Tests an AI support tool for anxiety in men newly diagnosed with metastatic prostate cancer.
Plain-language title generated from the registry record
Registry title: AI-Assisted Patient Support in mHSPC
Key facts
- Where
- Fuzhou, Kunming, Shanghai, and Wenzhou, ChinaSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07804030, who can take part
Where in China
- Fujian Cancer HospitalFuzhou, ChinaNo longer taking part
- Yunnan Cancer HospitalKunming, ChinaNo longer taking part
- Fudan University Shanghai Cancer CenterShanghai, ChinaNo longer taking part
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fudan University
- Trial code
- NCT07804030
- Record updated
- 4 September 2026
- Original description
The purpose of this multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Participants access the AI agent through a WeChat Mini Program-based platform. The study will also assess the effects of this intervention on illness perception, sleep quality, and patient satisfaction. Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will have access to the AI agent-enabled patient support platform throughout the 4-week study period. Participants in the control group will use the same platform without access to the AI agent during the first 2 weeks and will then receive access to the AI agent for the subsequent 2 weeks. Both groups will receive standard-of-care medical treatment throughout the study. The primary objective is to compare changes from baseline in anxiety at 2 weeks between the two groups. Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. Secondary outcomes include illness perception, sleep quality, and patient satisfaction. Exploratory outcomes include the change from baseline in the GAD-7 total score at 4 weeks and the accuracy of responses generated by the AI agent to participants' questions.Read full original descriptionShow less
Effects of Large LangUage Model-Based AI Agent-Assisted Patient-Centered Support on ANxiety, Illness PerceptiOn, and Sleep QUality in Patients With Newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
The purpose of this multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Participants access the AI agent through a WeChat Mini Program-based platform. The study will also assess the effects of this intervention on illness perception, sleep quality, and patient satisfaction. Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will have access to the AI agent-enabled patient support platform throughout the 4-week study period. Participants in the control group will use the same platform without access to the AI agent during the first 2 weeks and will then receive access to the AI agent for the subsequent 2 weeks. Both groups will receive standard-of-care medical treatment throughout the study. The primary objective is to compare changes from baseline in anxiety at 2 weeks between the two groups. Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. Secondary outcomes include illness perception, sleep quality, and patient satisfaction. Exploratory outcomes include the change from baseline in the GAD-7 total score at 4 weeks and the accuracy of responses generated by the AI agent to participants' questions.
Inclusion: Newly diagnosed prostate adenocarcinoma confirmed by histopathology or cytopathology; Metastatic disease confirmed by imaging or pathology; Diagnosis of metastatic prostate cancer within 2 weeks before enrollment; Aged 18-80 years; A GAD-7 score of 5 or higher at screening; Adequate cognitive ability to understand and participate in the study; Adequate language comprehension and ability to complete the study questionnaires independently; Access to a smartphone and an internet connection required to use the study platform; Provision of written informed consent.
Exclusion: A requirement for emergency surgery within 72 hours after enrollment; An acute or unstable psychiatric disorder, such as severe depressive or anxiety disorder, or severe insomnia requiring urgent specialist care; History of or current cognitive impairment, such as intellectual disability or Alzheimer's disease; Planned prostate cancer-directed radiotherapy, surgery, or chemotherapy during the study period; A request from the participant's family to withhold the diagnosis or disease-related information from the participant; Current participation in another interventional clinical trial.