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

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NLP-based Feedback
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer focused on measuring prostate, cancer, consultation, review, feedback, natural, process

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    NLP Intervention Experimental Arm

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Change in Decisional Conflict Scale Scores before and after intervention (patient-level outcome)
    The investigators will employ the validated Decisional Conflict Scale (DCS), to estimate uncertainty associated with treatment choice. Effect sizes of 0.3 to 0.4 are considered meaningful. Variability (standard deviation) in DCS scores before and after receiving NLP-based feedback will be assessed and used in planning a larger trial.
    Change in risk perception before and after intervention (patient-level outcome)
    The investigators will evaluate concordance of cancer risk perception with actual cancer risk at the patient level before and after the intervention. Cancer risk perception will be assessed by multiple-choice questions. Concordance of patient answers with actual cancer risk as estimated by outcomes of the SPCG-4 randomized trial comparing surgery versus watchful waiting at the patient's PCCI-predicted life expectancy will be assessed as a binary outcome. Risk perception will be assessed before and after their consultation. Variability (standard deviation) in risk perception scores before and after receiving NLP-based feedback will be assessed and used in planning a larger trial.
    Physician attitudes regarding integration of NLP-based information (physician-level outcome)
    30-minute semi-structured interviews with counseling physicians will be conducted within 2 weeks of the intervention to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.
    Difference between reported risk of side effects and prognosis with gold standard (physician-level outcome)
    The difference in reported risk estimates given by physicians during the consultation as compared with the gold standards for these risks (i.e. for side effects, estimates from the CAESAR study; for cancer risk with and without treatment, risks of cancer mortality in the WW group of SPCG-4 trial at the patient's life expectancy as determined by the prostate cancer comorbidity index). Variability (standard deviation) in accuracy of estimates will be assessed and used in planning a larger trial. Accuracy of estimates for the interventional period will be compared with physician-specific historical references from a previously conducted trial using the standard of care (i.e. no NLP-based intervention).
    Quality of composite physician risk communication score in treatment consultation (physician-level outcome)
    Quality of risk communication scores will be calculated by qualitatively analyzing treatment consultation transcripts to assess the highest quality of communication used to transmit information regarding all key tradeoffs (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms). The quality of risk communication scale ranges from 0 to 5 for each outcome, with 0 representing the lowest score and 5 representing the highest score (Daskivich et al, J Urol 2022; Naser-Tavakolian et al, J Urol 2022). Scores for all key tradeoffs will be averaged to yield a composite quality of risk communication score. Variability (standard deviation) in quality scores will be assessed and used in planning a larger trial.
    Patient attitudes regarding integration of NLP-based information
    30-minute semi-structured interviews with patients will be conducted at the conclusion of the study period to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback

    Secondary Outcome Measures

    Full Information

    First Posted
    May 24, 2023
    Last Updated
    June 27, 2023
    Sponsor
    Cedars-Sinai Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05923684
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2023 (Anticipated)
    Primary Completion Date
    July 15, 2024 (Anticipated)
    Study Completion Date
    July 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cedars-Sinai Medical Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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. 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. 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, any changes in individual physician communication over time, and accuracy of risk estimates for key content areas. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    prostate, cancer, consultation, review, feedback, natural, process

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NLP Intervention Experimental Arm
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    NLP-based Feedback
    Intervention Description
    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 Information:
    Title
    Change in Decisional Conflict Scale Scores before and after intervention (patient-level outcome)
    Description
    The investigators will employ the validated Decisional Conflict Scale (DCS), to estimate uncertainty associated with treatment choice. Effect sizes of 0.3 to 0.4 are considered meaningful. Variability (standard deviation) in DCS scores before and after receiving NLP-based feedback will be assessed and used in planning a larger trial.
    Time Frame
    Measured directly after treatment consultation and after NLP-based feedback given to patients within 2 weeks of consultation
    Title
    Change in risk perception before and after intervention (patient-level outcome)
    Description
    The investigators will evaluate concordance of cancer risk perception with actual cancer risk at the patient level before and after the intervention. Cancer risk perception will be assessed by multiple-choice questions. Concordance of patient answers with actual cancer risk as estimated by outcomes of the SPCG-4 randomized trial comparing surgery versus watchful waiting at the patient's PCCI-predicted life expectancy will be assessed as a binary outcome. Risk perception will be assessed before and after their consultation. Variability (standard deviation) in risk perception scores before and after receiving NLP-based feedback will be assessed and used in planning a larger trial.
    Time Frame
    Measured directly after treatment consultation and after NLP -based feedback given to patients within 2 weeks of consultation
    Title
    Physician attitudes regarding integration of NLP-based information (physician-level outcome)
    Description
    30-minute semi-structured interviews with counseling physicians will be conducted within 2 weeks of the intervention to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.
    Time Frame
    Interviews will be conducted within 2 weeks of the intervention.
    Title
    Difference between reported risk of side effects and prognosis with gold standard (physician-level outcome)
    Description
    The difference in reported risk estimates given by physicians during the consultation as compared with the gold standards for these risks (i.e. for side effects, estimates from the CAESAR study; for cancer risk with and without treatment, risks of cancer mortality in the WW group of SPCG-4 trial at the patient's life expectancy as determined by the prostate cancer comorbidity index). Variability (standard deviation) in accuracy of estimates will be assessed and used in planning a larger trial. Accuracy of estimates for the interventional period will be compared with physician-specific historical references from a previously conducted trial using the standard of care (i.e. no NLP-based intervention).
    Time Frame
    Data will be captured during the treatment consultation-for the duration of the study up to 1 year
    Title
    Quality of composite physician risk communication score in treatment consultation (physician-level outcome)
    Description
    Quality of risk communication scores will be calculated by qualitatively analyzing treatment consultation transcripts to assess the highest quality of communication used to transmit information regarding all key tradeoffs (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms). The quality of risk communication scale ranges from 0 to 5 for each outcome, with 0 representing the lowest score and 5 representing the highest score (Daskivich et al, J Urol 2022; Naser-Tavakolian et al, J Urol 2022). Scores for all key tradeoffs will be averaged to yield a composite quality of risk communication score. Variability (standard deviation) in quality scores will be assessed and used in planning a larger trial.
    Time Frame
    Data will be captured during the treatment consultation, for duration of the study up to 1 year
    Title
    Patient attitudes regarding integration of NLP-based information
    Description
    30-minute semi-structured interviews with patients will be conducted at the conclusion of the study period to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback
    Time Frame
    within 4 weeks of patients using NLP system.

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Timothy Daskivich, MD
    Phone
    3104230415
    Email
    timothy.daskivich@cshs.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antwon Chaplin
    Phone
    3102486790
    Email
    Antwon.Chaplin@cshs.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Timothy Daskivich
    Organizational Affiliation
    Cedars-Sinai Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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