Prostate surgeryLLM-assisted communicationRoutine preoperative communication
Prostate surgery: Including but not limited to open radical prostatectomy, laparoscopic radical prostatectomy (LapRP) and robot-assisted radical prostatectomy (RARP).
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.
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.
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from Baseline in the GAD-7 score (Generalized Anxiety Disorder 7-item Scale) after the Preoperative Communication between Two Groups. — At baseline and 24 hours after routine preoperative communication. 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.
Difference of the NASA-TLX (NASA Task Load Index) between Two Groups — 1 hour after routine preoperativecommunication. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.