RCT of NLP-Based Feedback for Improving SDM in Men With Localized Prostate Cancer (NLP RCT)

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Shared Decision Making; Risk Communication; Prostate Cancer

Treatments: Other: NLP+AI Report

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06856694

STUDY00003620

1R01CA290559-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 259 patients with newly diagnosed clinically localized prostate cancer will be cluster randomized within an evaluable 24 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.

Enrollment: 283 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Patient 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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283 participants in 2 patient groups

NLP-Based Feedback Arm

Experimental group

Treatment:

Other: NLP+AI Report

Standard of Care Arm

No Intervention group

Description:

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)