Prostate Cancer Clinical Trials

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Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Physician Inclusion Criteria

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

⁃ Patient Inclusion Criteria

• 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.

Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Timothy Daskivich, MD
Timothy.Daskivich@cshs.org
310-423-4700
Backup
Ella Tetrault, AB
Ella.Tetrault@cshs.org
424-315-1311
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2029-12
Participants
Target number of participants: 283
Treatments
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)
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov