NCT07082049Active, not recruiting
AI-LLM Communication Aid in Prostate Cancer Care (AI-CAP）
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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- 27 Jul 2025
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Fudan University
- Diseases
- Prostate cancer
- NCT number
- NCT07082049
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 27 Jul 2025 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requires emergency surgery (within 72 hours after diagnosis);
Other illness
- 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);
Other
- Has participated in other interventional clinical trials.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.