An interventional study of NLP+AI Report in Prostate Cancer, Shared Decision Making and Risk Communication, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Supportive care
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:
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 283 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Inclusion Criteria:
Physician Inclusion Criteria
(1) Physicians who typically counsel prostate cancer patients (Urology, Radiation Oncology, Medical Oncology)
Patient Inclusion Criteria
Patient Exclusion Criteria:
Other: NLP+AI Report
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)
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.
Decisional conflict
Decisional conflict is a patient-level outcome between intervention and control and will be measured using the validated Decisional Conflict Scale (DCS) questionnaire, where participants will list if they strongly agree, agree, neither, disagree, or strongly disagree with the provided statements
Time frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)
Shared decision-making
Shared decision making will be patient-reported and measured using the validated SDMP-4 questionnaire.
Time frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey
Appropriateness of treatment choice
Appropriateness of treatment choice will be determined a priori based on previously published measures determined by treatment guidelines.
Time frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)
Quality of risk communication
Physician level outcome-that will measure the difference in composite quality of physician risk communication between the experimental and control arms. Quality of physician risk communication will be measured using a previously published hierarchical scale that is specific to communication of cancer prognosis, life expectancy, and treatment-related side effects.
Time frame: 6-9 months (post study analysis)
Improvement of risk communication
Physician level outcome- improvement of risk communication in areas of deficiency in follow up calls between doctors and patients in the experimental arm. All of this information will be assessed retrospectively by qualitative analysis of treatment consultation transcripts.
Time frame: 6-9 months (post study analysis)
Risk Perception and Patient Satisfaction
Patients will fill out a REDCap questionnaire assessing risk perception and patient satisfaction with the intervention.
Time frame: 6-9 months (post study analysis)
Plan to share: No — Concerns regarding identification of participating individuals with raw consultation transcripts.
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