NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
NLP-based Feedback
BehavioralAudio 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: NLP Intervention Experimental ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Measured directly after treatment consultation and after NLP-based feedback given to patients within 2 weeks of consultation2
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.
Time frame
Measured directly after treatment consultation and after NLP -based feedback given to patients within 2 weeks of consultation3
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.
Time frame
Interviews will be conducted within 2 weeks of the intervention.4
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).
Time frame
Data will be captured during the treatment consultation-for the duration of the study up to 1 yearSponsors and contacts
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Cedars-Sinai Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov