[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657363":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":46,"overallOfficials":56,"centralContacts":60,"locations":66,"responsibleParty":82,"collaborators":25,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":25,"eligibilityCriteria":89,"healthyVolunteers":86,"sex":90,"minAge":91,"maxAge":25,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":105,"whyStopped":25,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information","Patient-perceived quality, breadth, and depth of cancer-related information received following an oncology consultation, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-INFO25) survey. The EORTC QLQ-INFO25 comprises four multi-item scales and eight single items to assess the level and quality of information received by cancer patients. Scores for all scales and single items range from 0-100. The survey uses a 4-point Likert scale (1 = \"not at all' to 4 = \"very much\") and some yes\u002Fno questions. Higher scores represent a greater patient-perceived level of shared decision-making. Mean differences between treatment groups will be reported with 95% confidence intervals, along with Hedges' g effect sizes. A Mann-Whitney U test will be used for sensitivity analysis.","Up to 2 days",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Mean differences on SDM-Q-9 and SDM-Q-Doc - Patient- and Provider-Perceived Shared Decision Making","Perceived shared decision making will be assessed from both patient and clinician perspectives using the 9-item Shared Decision Making Questionnaire (SDM-Q-9) and the Shared Decision Making Questionnaire-Physician Version (SDM-Q-Doc), respectively. Each item is rated on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree), with total scores ranging from 0 to 45. Higher scores indicate greater perceived levels of shared decision making from the patient or clinician perspective. Mean differences between groups will be reported using Welch's t-test, along with the 95% confidence intervals.","Day 21",{"measure":19,"description":20,"timeFrame":21},"Mean differences on NCCN Distress Thermometer - Patient-Reported Distress","Patient-reported distress will be assessed using the National Comprehensive Cancer Network (NCCN) Distress Thermometer at Day 2 and Day 21. The Distress Thermometer is a single-item measure rated on a 0-10 scale, where 0 = \"No distress\" and 10 = \"Extreme distress. Mean differences will be reported with 95% confidence intervals, along with Hedges' g effect sizes and 95% confidence intervals. Descriptive statistics will also be reported.","Up to 21 days",{"measure":23,"description":24,"timeFrame":17},"Patient-Provider Concordance in Shared Decision Making","Concordance between patient and provider perceptions of shared decision making will be assessed by comparing SDM-Q-9 and SDM-Q-Doc scores within each study arm. Concordance will be evaluated using an intraclass correlation coefficient (ICC). Bland-Altman plots will be used to visualize treatment group differences in concordance. ICC estimates and Bland-Altman plots will be reported.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","PRIMARY OBJECTIVE:\n\nI. To evaluate the impact of a LLM-based intervention on patients' perceived quality, breadth, and depth of cancer-related information following a radiation or surgical oncology consult.\n\nSECONDARY OBJECTIVES:\n\nI. To assess patient- and provider-perceived levels of shared decision making. II. To evaluate changes in patient-reported distress. III. To compare concordance between patient and provider perceptions of shared decision making.\n\nEXPLORATORY OBJECTIVES:\n\nI. To identify qualitative themes and usage patterns in patient interactions with the LLM.\n\nII. To evaluate resource utilization based on information-seeking behavior logs collected during follow-up.\n\nOUTLINE: Participants will be randomized to an intervention or control arm. Participants will attend two teleconference meetings: the first within 2 days after an oncology consultation and a follow-up session approximately 21 days later. Participants will also complete study surveys and logs.",[34,41],{"label":35,"type":36,"description":37,"interventionNames":38},"Intervention Arm","EXPERIMENTAL","AI teleconferences with Large Language Model (LLM) interaction",[39,40],"Behavioral: AI-guided COUNSEL Intervention","Behavioral: Questionnaires",{"label":42,"type":43,"description":44,"interventionNames":45},"Control Arm","PLACEBO_COMPARATOR","AI teleconferences without LLM interaction",[40],[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":25},"BEHAVIORAL","AI-guided COUNSEL Intervention","An AI-guided, interactive educational tool that allows participants to interact with a large language model (LLM) will be delivered via teleconference.",[35],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":25},"Questionnaires","Participant and clinicians will complete questionnaires",[42,35],[57],{"name":58,"affiliation":5,"role":59},"Julian Hong, MD, MS","PRINCIPAL_INVESTIGATOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":25,"email":65},"UCSF Genitourinary Medical Oncology Recruitment","CONTACT","877-827-3222","GUTrials@ucsf.edu",[67],{"facility":5,"status":25,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"San Francisco","California","94143","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-122.41942,37.77493,{"lat":77,"lon":76},[80,81],{"name":62,"role":63,"phone":64,"phoneExt":25,"email":65},{"name":58,"role":59,"phone":25,"phoneExt":25,"email":25},{"type":83,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100657363","cancer-oriented-understanding-and-navigation-via-supportive-and-educational-language-models-counsel-100657363",false,"NCT07836933","Cancer Oriented Understanding and Navigation Via Supportive and Educational Language Models (COUNSEL)","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed diagnosis of localized prostate cancer\n3. Newly diagnosed and planning to undergo or recently completed a radiation or surgical oncology consult at University of California, San Francisco (UCSF)\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n5. English-speaking and able to participate in study teleconferences\n6. Ability to understand and willingness to sign a written informed consent document\n7. Access to a device and internet connection sufficient for teleconference participation\n\nExclusion Criteria:\n\n1. Prior definitive treatment for prostate cancer (e.g., surgery, radiation, or systemic therapy)\n2. Cognitive, sensory, or language impairment that would interfere with the ability to understand, participate in, or complete the study procedures\n3. Inability or unwillingness to participate in two study-related teleconferences\n4. Current enrollment in another interventional clinical trial that may interfere with study participation\n5. Inability to comply with protocol requirements (e.g., completing surveys or using the information-tracking log)","ALL","18 Years",{"count":93,"type":94},50,"ESTIMATED","INTERVENTIONAL",[97],"NA","A randomized, open-label behavioral study designed to evaluate the feasibility, acceptability, and early impact of a large language model (LLM)-based artificial intelligence (AI) tool to support patient understanding following an initial oncology consultation.",[100,101,102],"Prostate Cancer","Prostatic Neoplasms","Patient Education as Topic",[104],"Artificial Intelligence","NOT_YET_RECRUITING","2026-09-24",{"date":108,"type":109},"2026-09-28","ACTUAL",{"date":111,"type":94},"2026-10-31",{"date":113,"type":94},"2028-04-30",{"name":5,"class":6},1]