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Prostate CancerAI-CAPNCT07082049

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

A study testing Prostate surgery, LLM-assisted communication and Routine preoperative communication in people with Prostate Cancer, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Prostate surgery, LLM-assisted communication and Routine preoperative communication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
27 Jul 2025to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: 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

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?

Read more

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
Being tested
Prostate surgery, LLM-assisted communication, Routine preoperative communication
Keywords
prostate cancer, large language model, anxiety, patient distress, healthcare efficiency
Medical subject headings
Prostatic Neoplasms, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostate surgeryProcedure or surgery

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

  • LLM-assisted communicationBehavioural

    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 communicationBehavioural

    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 groups in NCT07082049
Study groupRoleWhat they receive
LLM-assistedExperimentalPatients 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.
Receives: Procedure: Prostate surgery; Behavioral: LLM-assisted communication; Behavioral: Routine preoperative communication
Conventional routine communicationExperimentalPatients 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.
Receives: Procedure: Prostate surgery; Behavioral: Routine preoperative communication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 1 hour after routine preoperativecommunication.

Secondary outcomes (13)
  1. 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 anxietysymptoms. It consists of a single 10-centimeter line with anchors at either end (e.g., "no anxiety" at 0 and "extremeanxiety" at 10). Patients mark a point on the line to indicate their current anxiety level, and the score is measured asthe 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.

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

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

    Heart rate is measured under resting conditions, with two times measured, and the average value is calculated. Heart rate (HR) is defined as the number of heartbeats per minute (bpm), higher HR may signal adverse reactions, or physiological stress.

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

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

    Blood pressure (BP) is recorded as two values: systolic blood pressure (SBP) and diastolic blood pressure (DBP). BP is measured under resting conditions, with two measurements taken, and the average value is calculated. Higher BP value may indicate a more tense state.

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

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

    The PSQ-18, or Patient Satisfaction Questionnaire-18, is a scale designed to assess patient satisfaction with healthcare services. It consists of 18 items, each rated on a 5-point Likert scale (1 = "very dissatisfied" to 5 = "very satisfied") to evaluate domains like communication, accessibility, and quality of care.

    The total score ranges from 18 (minimum, indicating very low satisfaction) to 90 (maximum, indicating very high satisfaction).Higher scores on the PSQ-18 mean better outcomes, reflecting greater patient satisfaction with the healthcare experience.

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

  5. 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.

    The EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a widely used self-report scale assessing health-related quality of life (HRQoL) in cancer patients. It comprises 30 items measuring three domains: functional scales (e.g., physical, role, emotional function), symptom scales (e.g., fatigue, pain, nausea), and a global health status/HRQoL scale.

    Scores for each domain are linearly transformed to a range of 0 to 100. For functional scales and the global health status/HRQoL scale, higher scores indicate better outcomes (e.g., better physical function or overall quality of life).

    For symptom scales, higher scores indicate worse outcomes (e.g., more severe fatigue or pain).

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

  6. Change from Baseline in the APAIS (Amsterdam Preoperative Anxiety and Information Scale) after the Preoperative Communication between Two Groups.

    The APAIS (Amsterdam Preoperative Anxiety and Information Scale) is a tool designed to assess two key aspects of preoperative psychological state: anxiety related to surgery/anesthesia and the need for information about the procedure. It consists of 6 items, with 4 measuring anxiety (e.g., "I am worried about the anesthesia") and 2 assessing information needs (e.g., "I would like more information about what will happen during the operation"). Each item is rated on a 5-point Likert scale (1 = "not at all" to 5 = "extremely").

    The total score ranges from 6 (minimum, indicating very low anxiety and minimal information needs) to 30 (maximum, indicating severe anxiety and strong information needs). Higher scores on the APAIS generally mean worse outcomes, as they reflect greater preoperative anxiety (a negative psychological state) and/or heightened unmet information needs.

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

  7. Change from Baseline in the B-IPQ-PCa (Brief Illness Perception Questionnaire for Prostate Cancer) after the Preoperative Communication between Two Groups.

    The B-IPQ-PCa (Brief Illness Perception Questionnaire for Prostate Cancer) is a validated tool designed to assess prostate cancer patients' perceptions of their illness. It adapts the original Brief Illness Perception Questionnaire (B-IPQ) to focus on prostate cancer-specific experiences, measuring domains such as perceived illness timeline, consequences, personal/treatment control, identity (symptom burden), concern, emotional impact, and understanding of the illness.

    The scale typically includes 8 scored items rated on 0-10 scale. Total scores range from 0 (minimum, reflecting more positive/adaptive illness perceptions) to 80 (maximum, indicating more negative/maladaptive perceptions).

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

  8. 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).

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

  9. Difference of Routine Preoperative Communication Time between Two Groups [minutes]

    Duration of the routine preoperative communication, measured from the initiation of the discussion until the patient explicitly indicates no further questions, electronically timed and recorded in minutes.

    Measured: At the routine preoperative communication.

  10. Change from Baseline in the GAD-7 score (Generalized Anxiety Disorder 7-item Scale) after the LLM-assisted Preoperative Communication in LLM-assisted Group.

    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.

    Measured: At baseline and 24 hours after LLM-assisted preoperative communication.

  11. Change from Baseline in the VAS-A (Visual Analogue Scale for Anxiety) Scale after the LLM-assisted Preoperative Communication in LLM-assisted Group.

    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.

    Measured: At baseline and 24 hours after LLM-assisted preoperative communication.

  12. Change from Baseline in the MCMQ score (Medical Coping Modes Questionnaire) after the LLM-assisted Preoperative Communication in LLM-assisted Group.

    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).

    Measured: At baseline and 24 hours after LLM-assisted preoperative communication.

  13. Change from Baseline in the PANAS score (Positive and Negative Affect Schedule) after the LLM-assisted Preoperative Communication in LLM-assisted Group.

    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).

    Measured: At baseline and 24 hours after LLM-assisted preoperative communication.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start27 Jul 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07082049
Sponsor's protocol ID
FUSCC-AI-CAP
Acronym
AI-CAP
Status last verified
Jul 2026
First submitted
10 Jun 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Prostate surgery, LLM-assisted communication and Routine preoperative communication in people with Prostate Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the GAD-7 score (Generalized Anxiety Disorder 7-item Scale) after the Preoperative Communication between Two Groups. (time frame: At baseline and 24 hours after routine preoperative communication.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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