By InvitationNot Applicable

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

China160 participantsStarted 2025-02-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. A history of severe diagnosed mental illness (such as depression, anxiety disorder, insomnia);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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.

Timeframe: 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

Timeframe: 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.

Timeframe: At baseline and 24 hours after routine preoperative communication.

Trial details

NCT IDNCT07082049

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. A history of severe diagnosed mental illness (such as depression, anxiety disorder, insomnia);