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

NCT07082049 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-07-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Bo Dai, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2027-06-01
Completion
2028-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082049 on ClinicalTrials.gov