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Recruiting
NCT07082049
AI-LLM Communication Aid in Prostate Cancer Care (AI-CAP)
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Fudan University
Location: Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07082049). StuddyBuddy aggregates publicly available trial information.