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

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: NLP-based Feedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05923684

STUDY00002590

K08CA230155 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The primary research procedures are:

1. Audio recording and transcribing treatment counseling discussions for 20 men with newly diagnosed clinically localized prostate cancers and utilize NLP to extract key content using the system described above.
2. Reports including 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.
3. For patients, decisional conflict and risk perception will be assessed before and after receiving the NLP-based feedback.
4. For physicians, the investigators will assess baseline quality of risk communication, any changes in individual physician communication over time, and accuracy of risk estimates for key content areas.
5. Within 2 weeks of receiving the NLP-based feedback, the investigators will conduct a 30-minute semi-structured interview with patients to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.
6. At the conclusion of the pilot trial, the investigators will conduct 30-minute semi-structured interview with counseling physicians to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NLP Intervention Experimental Arm

Experimental group

Description:

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.

Treatment:

Behavioral: NLP-based Feedback