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

NCT07082049 | Enrolling By Invitation

• 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 (4)

• 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.

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

  The VAS-A (Visual Analogue Scale for Anxiety) is a simple scoring tool used to measure the severity of anxiety symptoms. It consists of a single 10-centimeter line with anchors at either end (e.g., "no anxiety" at 0 and "extreme anxiety" at 10). Patients mark a point on the line to indicate their current anxiety level, and the score is measured as the distance from the "no anxiety" end. The minimum score is 0 (indicating no anxiety) and the maximum score is 10 (indicating extreme anxiety). Higher scores mean worse outcomes, as they reflect more severe anxiety symptoms.

  At baseline and 24 hours after routine preoperative communication.

• Change from Baseline in the MCMQ score (Medical Coping Modes Questionnaire) after the Preoperative Communication between Two Groups

  The MCMQ score (Medical Coping Modes Questionnaire) is a scale designed to assess patients' coping strategies when facing illness. It typically consists of 20 items, with each item scored from 1 (least agreement) to 4 (most agreement), resulting in a total score ranging from 20 (minimum) to 80 (maximum). Higher scores alone do not universally indicate better or worse outcomes, as the scale measures three distinct coping dimensions: Confrontation (active engagement), Avoidance (distancing), and Resignation (passive acceptance). Higher scores on "Confrontation" often reflect more adaptive coping (better outcome), while higher scores on "Resignation" may indicate less adaptive coping (worse outcome).

  At baseline and 24 hours after routine preoperative communication.

• Change from Baseline in the PANAS score (Positive and Negative Affect Schedule) after the Preoperative Communication between Two Groups.

  The Positive and Negative Affect Schedule (PANAS) is a widely used psychological tool to measure an individual's positive and negative emotional states. It consists of 20 items (10 for positive affect, 10 for negative affect), with each item rated on a 5-point scale (1 = "very slightly or not at all" to 5 = "extremely"). For each dimension: the minimum score is 10 (little to no affect) and the maximum score is 50 (intense affect). Higher scores on the Positive Affect (PA) subscale indicate better outcomes (e.g., greater enthusiasm, alertness, or joy), while higher scores on the Negative Affect (NA) subscale indicate worse outcomes (e.g., more distress, fear, or anger).

  At baseline and 24 hours after routine preoperative communication.

Secondary Outcomes (11)

• 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.

• Change from Baseline in the APAIS (Amsterdam Preoperative Anxiety and Information Scale) 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: February 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)