Recruiting

NLP & AI

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06856694

Conditions

Prostate Cancer

Shared Decision Making

Risk Communication

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NLP+AI Report

Study Details

Brief summary:

The purpose of the research is to assess the impact of a natural language processing + artificial intelligence (NLP+AI)-based risk communication feedback system to improve quality of risk communication of key tradeoffs during prostate cancer consultations among physicians and to improve patient decision making. In this cluster randomized trial, an evaluable 259 patients with newly diagnosed clinically localized prostate cancer will be cluster randomized within an evaluable 24 physicians to:

1. a control arm, in which patients will receive standard of care treatment consultations along with AUA-endorsed educational materials on treatment risks and benefits (for patients) and on SDM (for physicians) or
2. an experimental arm, in which patients and participating physicians will receive NLP+AI-based feedback on what was said about key tradeoffs within approximately 72 hours of the consultation to assist with decision making. Physicians will additionally be provided with grading of their risk communication for each visit based on an a priori defined framework for quality of risk communication and recommendations for improvement.

In both study arms, there will be an audio-recorded follow-up phone or video call between the physician and patient to allow for further discussion of risk and clarifying any areas of ambiguity, which will be qualitatively analyzed to see if areas of poor communication were rectified. After the follow-up phone call, patients and participating physicians will be asked to complete a very brief survey about their experience.

The study plans to test whether receiving NLP+AI-based feedback improves decisional conflict, shared decision making, and appropriateness of treatment choice over the standard of care in patients undergoing treatment consultations for prostate cancer. Study staff will also test whether providing feedback and grading of risk communication to physicians affects quality of physician risk communication, since providing feedback will promote more accountability for the quality of information provided to patients. The study will also analyze data from the control arm of the randomized controlled trial to understand variation in risk communication of key tradeoffs in relevant subgroups of tumor risk (low-, intermediate-, and high-risk), provider specialty (Urology, Radiation Oncology, Medical Oncology), and patient sociodemographics.

Conditions

Prostate Cancer

Shared Decision Making

Risk Communication

Study ID

NCT06856694

Start date

Oct 22, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Physician Inclusion Criteria

(1) Physicians who typically counsel prostate cancer patients (Urology, Radiation Oncology, Medical Oncology)

Patient Inclusion Criteria

1. Patients undergoing initial treatment consultation for clinically localized prostate cancer;
2. Patients with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy;
3. Ability to read and write in English.

Patient Exclusion Criteria:

1. Under 18 years of age;
2. Subjects with difficulty communicating or dementia;
3. Non-English speakers, given that our NLP-based tools cannot be used with languages other than English;
4. Patients with locally advanced or metastatic prostate cancer;
5. Patients who have already been treated for clinically localized prostate cancer.

Study Design

Enrollment

283 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: NLP-Based Feedback Arm

no intervention: Standard of Care Arm

patients will receive standard of care treatment consultations along with AUA-endorsed educational materials on treatment risks and benefits (for patients) and on SDM (for physicians)

Interventions

NLP+AI Report

A NLP model will extract key content from consultations and AI (Chat GPT) will summarize that information. Reports including the top sentences by NLP probability for key content areas will be generated and will be provided to patients and providers within approximately 72 hours after each case. In both arms, a follow up phone call will allow for clarification any concepts that was inadequately communicated during the consultation. This call will be audio recorded and qualitatively assessed to determine whether deficiencies in risk communication observed in the consultation were rectified.

Primary outcome measure

  • Decisional conflict [ Time Frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey) ]
  • Shared decision-making [ Time Frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey ]
  • Appropriateness of treatment choice [ Time Frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey) ]
  • Quality of risk communication [ Time Frame: 6-9 months (post study analysis) ]

Central Contacts and Locations

Central contacts

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • prostate cancer
  • shared
  • decision
  • risk
  • communication
  • physician risk
  • natural language processing
  • NLP
  • artificial intelligence
  • AI
  • cluster
  • randomize
  • chatGPT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-12-11.