Recruiting

Risk Communication

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT05923684

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NLP-based Feedback

Study Details

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

Study ID

NCT05923684

Start date

Nov 15, 2023

Status verified date

Jul, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Men undergoing initial treatment consultation for clinically localized prostate cancer;
2. Men with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy.
3. Cedars-Sinai patient.
4. Ability to read and write in English.

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. Men with locally advanced or metastatic prostate cancer;
5. Men who have already been treated for clinically localized prostate cancer

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: NLP Intervention Experimental Arm

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.

Interventions

NLP-based Feedback

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.

Primary outcome measure

  • Change in Decisional Conflict Scale Scores before and after intervention (patient-level outcome) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: within 4 weeks of patients using NLP system. ]

Central Contacts and Locations

Central contacts

Timothy Daskivich, MD

3104230415timothy.daskivich@cshs.org

Ella Tetrault

4243151311Ella.Tetrault@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Timothy Daskivich, MD

3104230415timothy.daskivich@cshs.org

Antwon Chaplin, BA

3102486790antwon.chaplin@cshs.org

Principal Investigator:

Timothy Daskivich, MD

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Aug 12, 2026

Last verified

Jul, 2026

Keywords

  • prostate
  • cancer
  • consultation
  • review
  • feedback
  • natural
  • process

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-08-12.