Clinical trial NCT06856694: RCT of NLP-Based Feedback for Improving SDM in Men with Localized Prostate Cancer
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Shared Decision Making
Risk Communication
Keywords: prostate cancer
shared
decision
risk
communication
physician risk
natural language processing
NLP
artificial intelligence
AI
cluster
randomize
chatGPT
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-03-04
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this cluster randomized trial, an evaluable 220 patients with newly diagnosed clinically localized prostate cancer will be cluster randomized within an evaluable 22 physicians to:

1. a control arm, in which they will receive standard of care treatment consultations along with AUA-endorsed educational materials on treatment risks and benefits (for patients) and on SDM (for physicians) or
2. an experimental arm, in which patients and their physicians will receive NLP+AI-based feedback on what was said about key tradeoffs within approximately 72 hours of the consultation to assist with decision making.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the research is to assess the impact of a natural language processing + artificial intelligence (NLP+AI)-based risk communication feedback system to improve quality of risk communication of key tradeoffs during prostate cancer consultations among physicians and to improve patient decision making. In this cluster randomized trial, an evaluable 220 patients with newly diagnosed clinically localized prostate cancer will be cluster randomized within an evaluable 22 physicians to:

1. a control arm, in which patients will receive standard of care treatment consultations along with AUA-endorsed educational materials on treatment risks and benefits (for patients) and on SDM (for physicians) or
2. an experimental arm, in which patients and participating physicians will receive NLP+AI-based feedback on what was said about key tradeoffs within approximately 72 hours of the consultation to assist with decision making. Physicians will additionally be provided with grading of their risk communication for each visit based on an a priori defined framework for quality of risk communication and recommendations for improvement.

In both study arms, there will be an audio-recorded follow-up phone or video call between the physician and patient to allow for further discussion of risk and clarifying any areas of ambiguity, which will be qualitatively analyzed to see if areas of poor communication were rectified. After the follow-up phone call, patients and participating physicians will be asked to complete a very brief survey about their experience.

The study plans to test whether receiving NLP+AI-based feedback improves decisional conflict, shared decision making, and appropriateness of treatment choice over the standard of care in patients undergoing treatment consultations for prostate cancer. Study staff will also test whether providing feedback and grading of risk communication to physicians affects quality of physician risk communication, since providing feedback will promote more accountability for the quality of information provided to patients. The study will also analyze data from the control arm of the randomized controlled trial to understand variation in risk communication of key tradeoffs in relevant subgroups of tumor risk (low-, intermediate-, and high-risk), provider specialty (Urology, Radiation Oncology, Medical Oncology), and patient sociodemographics.


Eligibility criteria: Inclusion Criteria:

* Physician Inclusion Criteria (1) Physicians who typically counsel prostate cancer patients (Urology, Radiation Oncology, Medical Oncology)

Patient Inclusion Criteria

1. Patients undergoing initial treatment consultation for clinically localized prostate cancer;
2. Patients with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy;
3. 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. Patients with locally advanced or metastatic prostate cancer;
5. Patients who have already been treated for clinically localized prostate cancer.

Primary outcomes:
measure: Decisional conflict
timeFrame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)
measure: Shared decision-making
timeFrame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey
measure: Appropriateness of treatment choice
timeFrame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)
measure: Quality of risk communication
timeFrame: 6-9 months (post study analysis)
Secondary outcomes:
measure: Improvement of risk communication
timeFrame: 6-9 months (post study analysis)
measure: Risk Perception and Patient Satisfaction
timeFrame: 6-9 months (post study analysis)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
References: