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

NCT06856694 | Recruiting DMC

• 2 other identifiers: STUDY000036201R01CA290559-01A1
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Prostate Cancer; Shared Decision Making; Risk Communication

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  6-9 months (post study analysis)

Secondary Outcomes (2)

• Improvement of risk communication

  6-9 months (post study analysis)

• Risk Perception and Patient Satisfaction

  6-9 months (post study analysis)

Study Arms (2)

NLP-Based Feedback Arm

EXPERIMENTAL

Other: NLP+AI Report

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)

Interventions

NLP+AI Report OTHER

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.

NLP-Based Feedback Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cis-gendered men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Physicians who typically counsel prostate cancer patients (Urology, Radiation Oncology, Medical Oncology)
• Patients undergoing initial treatment consultation for clinically localized prostate cancer;
• Patients with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy;
• Ability to read and write in English.

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Communication

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Central Study Contacts

Timothy Daskivich, MD

CONTACT

310-423-4700; Timothy.Daskivich@cshs.org

Ella Tetrault, AB

CONTACT

424-315-1311; Ella.Tetrault@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician II

Model Details: 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 they 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 their 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.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 4, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)