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Trial Title:
NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making
NCT ID:
NCT05923684
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate
cancer
consultation
review
feedback
natural
process
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
NLP-based Feedback
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.
Arm group label:
NLP Intervention Experimental Arm
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Timothy Daskivich, MD
Phone:
310-423-0415
Email:
timothy.daskivich@cshs.org
Contact backup:
Last name:
Antwon Chaplin, BA
Phone:
3102486790
Email:
antwon.chaplin@cshs.org
Investigator:
Last name:
Timothy Daskivich, MD
Email:
Principal Investigator
Start date:
November 15, 2023
Completion date:
July 15, 2025
Lead sponsor:
Agency:
Cedars-Sinai Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05923684
