NCT07804030Not yet recruiting
AI-Assisted Patient Support in mHSPC
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- Fudan University
- Diseases
- Prostate cancer
- NCT number
- NCT07804030
What you commit to
- Study type: Interventional
- Planned participants: 160
- From Sept 2026 to the primary completion date, Feb 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A requirement for emergency surgery within 72 hours after enrollment;
Other illness
- 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.
Other
- Current participation in another interventional clinical trial;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.