NCT07082049

AI-LLM Communication Aid in Prostate Cancer Care (AI-CAP）

A Randomized Controlled Trial on Artificial Intelligence-Powered Large Language Model-Assisted Doctor-Patient Preoperative Communication for Psychological Distress Alleviation and Healthcare Efficiency Improvement in Prostate Cancer Patients

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy of large language model (LLM)-assisted communication on psychological distress alleviation and healthcare efficiency improvement in prostate cancer patients. The main questions it aims to answer are: Does LLM-assisted communication reduce preoperative anxiety and negative emotion more effectively than standard care? Can LLM-assisted communication decrease clinician workload while maintaining communication quality? Researchers will compare the intervention group (LLM-assisted communication) with the control group (standard communication) to see: Whether LLM-assisted communication has greater reductions in patients' emotional distress scales and physiological stress metrics. How it impacts clinician workload and communication time. Participants will: Undergo baseline assessments before communication, including a range of emotional scales and physiological metrics. Receive clinician-reviewed LLM-generated materials and/or standard communication before surgery. Complete assessments after preoperative communication.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Prostate surgery	Including but not limited to open radical prostatectomy, laparoscopic radical prostatectomy (LapRP) and robot-assisted radical prostatectomy (RARP).
BEHAVIORAL	LLM-assisted communication	Preoperatively, patients will communicate with the LLM, which will provide direct answers to their various questions, including but not limited to diagnosis, treatment options, operative risks, and complication management. To ensure the accuracy of LLM-generated responses in real-world clinical settings, all answers will undergo verification by the researchers before being provided to patients.
BEHAVIORAL	Routine preoperative communication	Preoperatively, patients will attend a consultation with the attending surgeon and surgical team. This physician-led communication will comprehensively discuss, current disease status, treatment options, operative risks, potential complication. The surgical team will subsequently address patient inquiries, followed by executing the informed consent form.

Timeline

• Start date: 2025-02-15
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: China