Prostate CancerNLP RCTNCT06856694
RCT of NLP-Based Feedback for Improving SDM in Men With Localized Prostate Cancer
A study testing NLP+AI Report in people with Prostate Cancer and Shared Decision Making, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Shared Decision Making, Risk Communication
- What is being tested?
- NLP+AI Report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician Inclusion Criteria
- Physicians who typically counsel prostate cancer patients (Urology, Radiation Oncology, Medical Oncology)
- Patient Inclusion Criteria
- Patients undergoing initial treatment consultation for clinically localized prostate cancer;
- Patients with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy;
- Ability to read and write in English.
Show all 12Show fewer
- Patient 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;
- Patients with locally advanced or metastatic prostate cancer;
- Patients who have already been treated for clinically localized prostate cancer.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer
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:
- 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
- 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.
Read more
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.
- Conditions
- Prostate Cancer, Shared Decision Making, Risk Communication
- Being tested
- NLP+AI Report
- Keywords
- prostate cancer, shared, decision, risk, communication, physician risk, natural language processing, NLP, artificial intelligence, AI, cluster, randomize, chatGPT
- Medical subject headings
- Prostatic Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NLP+AI ReportOther
A NLP model will extract key content from consultations and AI (Chat GPT) will summarize that information. Reports including the top sentences by NLP probability for key content areas will be generated and will be provided to patients and providers within approximately 72 hours after each case. In both arms, a follow up phone call will allow for clarification any concepts that was inadequately communicated during the consultation. This call will be audio recorded and qualitatively assessed to determine whether deficiencies in risk communication observed in the consultation were rectified.
| Study group | Role | What they receive |
|---|---|---|
| NLP-Based Feedback Arm | Experimental | Not described Receives: Other: NLP+AI Report |
| Standard of Care Arm | No intervention | 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
Decisional conflict is a patient-level outcome between intervention and control and will be measured using the validated Decisional Conflict Scale (DCS) questionnaire, where participants will list if they strongly agree, agree, neither, disagree, or strongly disagree with the provided statements
Measured: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)
Shared decision-making
Shared decision making will be patient-reported and measured using the validated SDMP-4 questionnaire.
Measured: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey
Appropriateness of treatment choice
Appropriateness of treatment choice will be determined a priori based on previously published measures determined by treatment guidelines.
Measured: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)
Quality of risk communication
Physician level outcome-that will measure the difference in composite quality of physician risk communication between the experimental and control arms. Quality of physician risk communication will be measured using a previously published hierarchical scale that is specific to communication of cancer prognosis, life expectancy, and treatment-related side effects.
Measured: 6-9 months (post study analysis)
Secondary outcomes (2)
Improvement of risk communication
Physician level outcome- improvement of risk communication in areas of deficiency in follow up calls between doctors and patients in the experimental arm. All of this information will be assessed retrospectively by qualitative analysis of treatment consultation transcripts.
Measured: 6-9 months (post study analysis)
Risk Perception and Patient Satisfaction
Patients will fill out a REDCap questionnaire assessing risk perception and patient satisfaction with the intervention.
Measured: 6-9 months (post study analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start22 Oct 2025
- Primary completionMay 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 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.
- Masking
- None (open label)
- Enrolment
- 283 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Timothy J. Daskivich, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856694
- Sponsor's protocol ID
- STUDY00003620
- Other IDs
- 1R01CA290559-01A1
- Acronym
- NLP RCT
- Status last verified
- Dec 2025
- First submitted
- 14 Feb 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Concerns regarding identification of participating individuals with raw consultation transcripts.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06856694
- Acronym / sponsor ID
- NLP RCT / STUDY00003620
- Conditions
- Prostate Cancer, Shared Decision Making, Risk Communication
- Keywords
- prostate cancer, shared, decision, risk, communication, physician risk, natural language processing, NLP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 283 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 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.
| Arm | Type | Receives |
|---|---|---|
| NLP-Based Feedback Arm | Experimental | Other: NLP+AI Report |
| Standard of Care Arm | No intervention | –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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Physician Inclusion Criteria
- Physicians who typically counsel prostate cancer patients (Urology, Radiation Oncology, Medical Oncology)
- Patient Inclusion Criteria
- Patients undergoing initial treatment consultation for clinically localized prostate cancer;
- Patients with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NLP+AI ReportA NLP model will extract key content from consultations and AI (Chat GPT) will summarize that information. Reports including the top sentences by NLP probability for key content areas will be generated and will be provided to patients and providers within approximately 72 hours after each case. In both arms, a follow up phone call will allow for clarification any concepts that was inadequately communicated during the consultation. This call will be audio recorded and qualitatively assessed to determine whether deficiencies in risk communication observed in the consultation were rectified. | Other | NLP-Based Feedback Arm |
Primary outcome
Decisional conflict
Time frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)
Decisional conflict is a patient-level outcome between intervention and control and will be measured using the validated Decisional Conflict Scale (DCS) questionnaire, where participants will list if they strongly agree, agree, neither, disagree, or strongly disagree with the provided statements
Shared decision-making
Time frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey
Shared decision making will be patient-reported and measured using the validated SDMP-4 questionnaire.
Appropriateness of treatment choice
Time frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)
Appropriateness of treatment choice will be determined a priori based on previously published measures determined by treatment guidelines.
Quality of risk communication
Time frame: 6-9 months (post study analysis)
Physician level outcome-that will measure the difference in composite quality of physician risk communication between the experimental and control arms. Quality of physician risk communication will be measured using a previously published hierarchical scale that is specific to communication of cancer prognosis, life expectancy, and treatment-related side effects.
2 secondary outcomes
Improvement of risk communication
Time frame: 6-9 months (post study analysis)
Risk Perception and Patient Satisfaction
Time frame: 6-9 months (post study analysis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No. Concerns regarding identification of participating individuals with raw consultation transcripts.
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NLP+AI Report in people with Prostate Cancer and Shared Decision Making, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Daskivich, MD (310-423-4700, Timothy.Daskivich@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.