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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Cedars-Sinai Medical Center — Los Angeles

Идентификаторы

NCT: NCT05923684 · STUDY00002590 · K08CA230155

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗