AI-Assisted Patient Support in mHSPC

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 Criteria: 1. Newly diagnosed prostate adenocarcinoma confirmed by histopathology or cytopathology; 2. Metastatic disease confirmed by imaging or pathology; 3. Diagnosis of metastatic prostate cancer within 2 weeks before enrollment; 4. Aged 18-80 years; 5. A GAD-7 score of 5 or higher at screening; 6. Adequate cognitive ability to understand and participate in the study; 7. Adequate language comprehension and ability to complete the study questionnaires independently; 8. Access to a smartphone and an internet connection required to use the study platform; 9. Provision of written informed consent. Exclusion Criteria: 1. An acute or unstable psychiatric disorder, such as severe depressive or anxiety disorder, or severe insomnia requiring urgent specialist care; 2. History of or current cognitive impairment, such as intellectual disability or Alzheimer's disease; 3. A requirement for emergency surgery within 72 hours after enrollment; 4. Planned prostate cancer-directed radiotherapy, surgery, or chemotherapy during the study period; 5. Current participation in another interventional clinical trial; 6. A request from the participant's family to withhold the diagnosis or disease-related information from the participant.