NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making (NCT05923684) | Clinical Trial Compass
RecruitingNot Applicable
NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making
United States30 participantsStarted 2023-11-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Decisional Conflict Scale Scores before and after intervention (patient-level outcome)
Timeframe: Measured directly after treatment consultation and after NLP-based feedback given to patients within 2 weeks of consultation
2
Change in risk perception before and after intervention (patient-level outcome)
Timeframe: Measured directly after treatment consultation and after NLP -based feedback given to patients within 2 weeks of consultation
3
Physician attitudes regarding integration of NLP-based information (physician-level outcome)
Timeframe: 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)
Timeframe: Data will be captured during the treatment consultation-for the duration of the study up to 1 year
5
Quality of composite physician risk communication score in treatment consultation (physician-level outcome)
Timeframe: Data will be captured during the treatment consultation, for duration of the study up to 1 year
6
Patient attitudes regarding integration of NLP-based information