NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NLP-based Feedback.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer
Overview
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.
Interventions
- Behavioral 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
Primary outcome measures
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT05923684 · STUDY00002590 · K08CA230155