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

Fudan University

Status: Invitation-only

Conditions: Prostate Cancer

Treatments: Behavioral: Routine preoperative communication; Procedure: Prostate surgery; Behavioral: LLM-assisted communication

Study type: Interventional

Funder types: Other

Identifiers

NCT07082049

FUSCC-AI-CAP

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Newly diagnosed prostate adenocarcinoma confirmed by histopathology;
2. Age 18 years or older;
3. Must be a candidate for radical prostatectomy, including but not limited to laparoscopic radical prostatectomy (LapRP) and robot-assisted radical prostatectomy (RARP);
4. Ability to independently complete questionnaire filling and possess basic language comprehension ability;
5. Ability to understand and willingness to sign informed consent.

Exclusion criteria

1. A history of severe diagnosed mental illness (such as depression, anxiety disorder, insomnia);
2. A history of diagnosed cognitive dysfunction (such as intellectual disability, Parkinson's disease);
3. Requires emergency surgery (within 72 hours after diagnosis);
4. Has participated in other interventional clinical trials.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

LLM-assisted

Experimental group

Description:

Patients will communicate with the LLM before surgery, which will provide answers based on their various concerns, including diagnosis, surgical plan selection, surgery risks, and handling of complications. Subsequently, patients will also continue to participate in the routine pre-operative communication held by surgeons.

Treatment:

Behavioral: LLM-assisted communication

Procedure: Prostate surgery

Behavioral: Routine preoperative communication

Conventional routine communication

Experimental group

Description:

Patients will participate routine pre-operative communication, held by the surgical team's lead physician, to inform the patient about the surgical plan selection, surgery risks, and the situation regarding post-operative complications, as well as to answer any patient inquiries.

Treatment:

Procedure: Prostate surgery

Behavioral: Routine preoperative communication