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

NCT07082049 | Active Not Recruiting

• 1 other identifier: FUSCC-AI-CAP
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prostate cancer; large language model; anxiety; patient distress; healthcare efficiency

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in the GAD-7 score (Generalized Anxiety Disorder 7-item Scale) after the Preoperative Communication between Two Groups.

  GAD-7 (Generalized Anxiety Disorder 7-item Scale) is a scale used to assess anxiety-related symptoms. Each of its 7 items is scored from a minimum of 0 to a maximum of 3 points, resulting in a total score ranging from 0 to 21. Higher scores indicate worse outcomes, as they reflect more severe anxiety symptoms.

  At baseline and 24 hours after routine preoperative communication.

• Difference of the NASA-TLX (NASA Task Load Index) between Two Groups

  The NASA-TLX (NASA Task Load Index) is a widely used subjective assessment tool designed to measure perceivedworkload associated with performing a task. It evaluates six dimensions of workload: Mental Demand (cognitiveeffort), Physical Demand (physical effort), Temporal Demand (time pressure), Performance (self-rated task success),Effort (amount of work invested), and Frustration Level (stress or irritation). Each dimension is rated by the participant on a 0-20 scale (0 = "very low" to 20 = "very high"). These ratings arecombined to generate an overall workload score, which ranges from 0 (minimum, indicating negligible workload) to120 (maximum, indicating extreme workload). Higher scores on the NASA-TLX mean worse outcomes, as they reflect greater perceived task difficulty,cognitive/physical strain, or stress associated with the task.

  1 hour after routine preoperativecommunication.

Secondary Outcomes (13)

• Change from Baseline in the VAS-A (Visual Analogue Scale-Anxiety) after the Preoperative Communication between Two Groups.

  At baseline and 24 hours after routine preoperative communication.

• Change from Baseline in the Heart Rate after the Preoperative Communication between Two Groups.

  At baseline and 24 hours after routine preoperative communication.

• Change from Baseline in the Blood Pressure after the Preoperative Communication between Two Groups.

  At baseline and 24 hours after routine preoperative communication.

• Change from Baseline in the PSQ-18 ( Patient Satisfaction Questionnaire-18) after the Preoperative Communication between Two Groups.

  At baseline and 24 hours after routine preoperative communication.

• Change from Baseline in the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) after the Preoperative Communication between Two Groups.

  At baseline and 24 hours after routine preoperative communication.

Study Arms (2)

LLM-assisted

EXPERIMENTAL

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.

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

Conventional routine communication

EXPERIMENTAL

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.

Procedure: Prostate surgery; Behavioral: Routine preoperative communication

Interventions

Prostate surgery PROCEDURE

Including but not limited to open radical prostatectomy, laparoscopic radical prostatectomy (LapRP) and robot-assisted radical prostatectomy (RARP).

Conventional routine communication; LLM-assisted

LLM-assisted communication BEHAVIORAL

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.

LLM-assisted

Routine preoperative communication BEHAVIORAL

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.

Conventional routine communication; LLM-assisted

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders

Study Officials

• Bo Dai, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 24, 2025
• Study Start: July 27, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)