A Randomized Controlled Trial on Artificial Intelligence-Powered Large Language Model-Assisted Doctor-Patient Preoperative Communication for Psychological Distress Alleviation and Healthcare Efficiency Improvement in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Difference of the NASA-TLX (NASA Task Load Index) between Two Groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
LLM-assisted
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.
干预措施: Prostate surgery (Procedure)
LLM-assisted
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.
干预措施: LLM-assisted communication (Behavioral)
LLM-assisted
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.
干预措施: Routine preoperative communication (Behavioral)
Conventional routine communication
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.
干预措施: Prostate surgery (Procedure)
Conventional routine communication
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.
干预措施: Routine preoperative communication (Behavioral)
结局指标
主要结局
Difference of the NASA-TLX (NASA Task Load Index) between Two Groups
时间窗: 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.
Change from Baseline in the GAD-7 score (Generalized Anxiety Disorder 7-item Scale) after the Preoperative Communication between Two Groups.
时间窗: 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.
Change from Baseline in the VAS-A (Visual Analogue Scale-Anxiety) after the Preoperative Communication between Two Groups.
时间窗: At baseline and 24 hours after routine preoperative communication.
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.
Change from Baseline in the MCMQ score (Medical Coping Modes Questionnaire) after the Preoperative Communication between Two Groups
时间窗: At baseline and 24 hours after routine preoperative communication.
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).
Change from Baseline in the PANAS score (Positive and Negative Affect Schedule) after the Preoperative Communication between Two Groups.
时间窗: At baseline and 24 hours after routine preoperative communication.
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).
次要结局
- 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 PANAS score (Positive and Negative Affect Schedule) after the Preoperative Communication between Two Groups.(At baseline and 24 hours after routine preoperative communication.)
- Difference of Routine Preoperative Communication Time between Two Groups [minutes](At the 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.)
- 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.)
- Change from Baseline in the B-IPQ-PCa (Brief Illness Perception Questionnaire for Prostate Cancer) after the Preoperative Communication between Two Groups.(At baseline and 24 hours after routine preoperative communication.)
- Difference of the NASA-TLX (NASA Task Load Index) between Two Groups(1 hour after routine preoperative communication.)
- Change from Baseline in the GAD-7 score (Generalized Anxiety Disorder 7-item Scale) after the LLM-assisted Preoperative Communication in LLM-assisted Group.(At baseline and 24 hours after LLM-assisted preoperative communication.)
- Change from Baseline in the VAS-A (Visual Analogue Scale for Anxiety) Scale after the LLM-assisted Preoperative Communication in LLM-assisted Group.(At baseline and 24 hours after LLM-assisted preoperative communication.)
- Change from Baseline in the MCMQ score (Medical Coping Modes Questionnaire) after the LLM-assisted Preoperative Communication in LLM-assisted Group.(At baseline and 24 hours after LLM-assisted preoperative communication.)
- Change from Baseline in the PANAS score (Positive and Negative Affect Schedule) after the LLM-assisted Preoperative Communication in LLM-assisted Group.(At baseline and 24 hours after LLM-assisted preoperative communication.)
研究者
Bo Dai
Principal Investigator
Fudan University