Clinical trial NCT05923684: NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making
Official title: Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate
cancer
consultation
review
feedback
natural
process
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-06-28
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Decisional Conflict Scale Scores before and after intervention (patient-level outcome)
timeFrame: Measured directly after treatment consultation and after NLP-based feedback given to patients within 2 weeks of consultation
measure: Change in risk perception before and after intervention (patient-level outcome)
timeFrame: Measured directly after treatment consultation and after NLP -based feedback given to patients within 2 weeks of consultation
measure: Physician attitudes regarding integration of NLP-based information (physician-level outcome)
timeFrame: Interviews will be conducted within 2 weeks of the intervention.
measure: Difference between reported risk of side effects and prognosis with gold standard (physician-level outcome)
timeFrame: Data will be captured during the treatment consultation-for the duration of the study up to 1 year
measure: Quality of composite physician risk communication score in treatment consultation (physician-level outcome)
timeFrame: Data will be captured during the treatment consultation, for duration of the study up to 1 year
measure: Patient attitudes regarding integration of NLP-based information
timeFrame: within 4 weeks of patients using NLP system.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Timothy Daskivich
role: PRINCIPAL_INVESTIGATOR
References: