Active, not recruitingNot applicableMale onlyEN originalProstate cancer

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

This trial is no longer recruiting — here are similar active trials

Matched by cancer type/biomarker, currently recruiting.

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RecruitingNot applicable🇵🇱 PolandMale onlyProstate cancer

Transperineal prostate biopsy is a safe and effective method of diagnosing prostate cancer. When performed under local anaesthesia in an outpatient setting, it can cause significant pain, particularly during the periprostatic nerve block - the injection of local anaesthetic around the prostate. Better pain management during this procedure may improve patient comfort and encourage wider use of the transperineal approach. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, low-cost method of pain relief that works by delivering mild electrical impulses through the skin. A preceding pilot study at our centre (n=84) found that TENS used alongside local anaesthesia was associated with significantly lower pain scores during periprostatic nerve block and biopsy sampling, with no device-related complications. This study aims to confirm these findings in a larger, formally powered, triple-blind, randomized controlled trial. Participants will be randomly assigned to receive either active TENS or sham TENS (electrodes applied but no electrical current delivered) in addition to standard local anaesthesia. Neither the participant nor the operating urologist will know which group the participant is in. Pain scores are written down by the participant himself, so nobody asks him for a number during the procedure. Stimulation may feel strong, weak or not noticeable at all, and feeling nothing does not mean a participant is in the inactive group. Pain intensity will be assessed at four stages of the procedure using a 0-10 numeric rating scale. Participants will be followed up at 30 days after the biopsy.

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About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Nowotwór prostaty potwierdzony badaniem.
  • Osoby w wieku 18 lat lub starsze.
  • Kandydaci do operacji usunięcia prostaty.
  • Zdolność do samodzielnego wypełniania ankiet i rozumienia języka.
  • Zrozumienie i chęć podpisania zgody na udział w badaniu.

✗ Disqualifies

  • Historia poważnych problemów ze zdrowiem psychicznym (np. depresja, silny lęk).
  • Historia problemów z myśleniem lub pamięcią (np. choroba Parkinsona).
  • Potrzeba pilnej operacji (w ciągu 3 dni od diagnozy).
  • Udział w innych badaniach klinicznych.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 7, 2026
Sex
Male only

Therapies / drugs in trial

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.

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