RCT of NLP-Based Feedback for Improving SDM in Men With Localized Prostate Cancer

Clinicaltrials.gov ID: NCT06856694
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 283

Conditions

Prostate Cancer, Shared Decision Making, Risk Communication

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Eligibility Criteria

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 Plan

NLP-Based Feedback Arm

  • OTHER:

    NLP+AI Report

    Description:

    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.

Standard of Care Arm

NO_INTERVENTION

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)

    Outcome Measures

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Improvement of risk communication

    Time Frame: 6-9 months (post study analysis)

    Risk Perception and Patient Satisfaction

    Time Frame: 6-9 months (post study analysis)

    Timeline

    • Last Updated
      December 11, 2025
    • Start Date
      March 4, 2025
    • Today
      December 26, 2025
    • Completion Date ( Estimated )
      December 1, 2029

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