NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making

NCT05923684 | Recruiting

• 2 other identifiers: STUDY00002590K08CA230155
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this pilot study, the investigators will show feasibility of the NLP-based feedback system in 20 consultations of men with newly diagnosed prostate cancer. The investigators will recruit from the practices of up to 10 physicians who typically see these patients. The investigators will report the top five sentences from each consultation across key content areas (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms) to both patients and physicians within 2 weeks of the consultation.

Conditions

Prostate Cancer

Keywords

prostate; cancer; consultation; review; feedback; natural; process

Outcome Measures

Primary Outcomes (6)

• Change in Decisional Conflict Scale Scores before and after intervention (patient-level outcome)

  The investigators will employ the validated Decisional Conflict Scale (DCS), to estimate uncertainty associated with treatment choice. Effect sizes of 0.3 to 0.4 are considered meaningful. Variability (standard deviation) in DCS scores before and after receiving NLP-based feedback will be assessed and used in planning a larger trial.

  Measured directly after treatment consultation and after NLP-based feedback given to patients within 2 weeks of consultation

• Change in risk perception before and after intervention (patient-level outcome)

  The investigators will evaluate concordance of cancer risk perception with actual cancer risk at the patient level before and after the intervention. Cancer risk perception will be assessed by multiple-choice questions. Concordance of patient answers with actual cancer risk as estimated by outcomes of the SPCG-4 randomized trial comparing surgery versus watchful waiting at the patient's PCCI-predicted life expectancy will be assessed as a binary outcome. Risk perception will be assessed before and after their consultation. Variability (standard deviation) in risk perception scores before and after receiving NLP-based feedback will be assessed and used in planning a larger trial.

  Measured directly after treatment consultation and after NLP -based feedback given to patients within 2 weeks of consultation

• Physician attitudes regarding integration of NLP-based information (physician-level outcome)

  30-minute semi-structured interviews with counseling physicians will be conducted within 2 weeks of the intervention to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.

  Interviews will be conducted within 2 weeks of the intervention.

• Difference between reported risk of side effects and prognosis with gold standard (physician-level outcome)

  The difference in reported risk estimates given by physicians during the consultation as compared with the gold standards for these risks (i.e. for side effects, estimates from the CAESAR study; for cancer risk with and without treatment, risks of cancer mortality in the WW group of SPCG-4 trial at the patient's life expectancy as determined by the prostate cancer comorbidity index). Variability (standard deviation) in accuracy of estimates will be assessed and used in planning a larger trial. Accuracy of estimates for the interventional period will be compared with physician-specific historical references from a previously conducted trial using the standard of care (i.e. no NLP-based intervention).

  Data will be captured during the treatment consultation-for the duration of the study up to 1 year

• Quality of composite physician risk communication score in treatment consultation (physician-level outcome)

  Quality of risk communication scores will be calculated by qualitatively analyzing treatment consultation transcripts to assess the highest quality of communication used to transmit information regarding all key tradeoffs (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms). The quality of risk communication scale ranges from 0 to 5 for each outcome, with 0 representing the lowest score and 5 representing the highest score (Daskivich et al, J Urol 2022; Naser-Tavakolian et al, J Urol 2022). Scores for all key tradeoffs will be averaged to yield a composite quality of risk communication score. Variability (standard deviation) in quality scores will be assessed and used in planning a larger trial.

  Data will be captured during the treatment consultation, for duration of the study up to 1 year

• Patient attitudes regarding integration of NLP-based information

  30-minute semi-structured interviews with patients will be conducted at the conclusion of the study period to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback

  within 4 weeks of patients using NLP system.

Study Arms (1)

NLP Intervention Experimental Arm

EXPERIMENTAL

20 men with newly diagnosed clinically localized prostate cancers and utilize NLP to extract key content using the top five sentences by NLP probability for key content areas will be generated and will be provided to patients and providers within 2 weeks after each case.

Behavioral: NLP-based Feedback

Interventions

NLP-based Feedback BEHAVIORAL

Audio recordings will be made using either digital recorders or telehealth platform-generated transcripts. Patient reports will include only the extracted sentences related to content areas. Physician reports will note the extracted statements across each content area, the quality scores for individual statements based on the pre-specified hierarchy, the statements that achieved the highest score across each content area, and feedback on what could be improved. For patients, decisional conflict and risk perception will be assessed before and after receiving the NLP-based feedback. For physicians, the investigators will assess baseline quality of risk communication by pre-specified hierarchy, any changes in individual physician communication over time, and accuracy of risk estimates for key content areas.

NLP Intervention Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men undergoing initial treatment consultation for clinically localized prostate cancer;
• Men with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy.
• Cedars-Sinai patient.
• 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;
• Men with locally advanced or metastatic prostate cancer;
• Men 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; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Timothy Daskivich

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Daskivich, MD

CONTACT

3104230415; timothy.daskivich@cshs.org

Antwon Chaplin

CONTACT

3102486790; Antwon.Chaplin@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Urology

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 28, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)