Clinical trial · Interventional
Cancer Oriented Understanding and Navigation Via Supportive and Educational Language Models (COUNSEL)
NCT07836933CI-TRIAL-00126559not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patient Education as Topic | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-guided COUNSEL Intervention | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- AI teleconferences with Large Language Model (LLM) interaction
- interventionNames
- Behavioral: AI-guided COUNSEL Intervention
- Behavioral: Questionnaires
- type
- PLACEBO_COMPARATOR
- label
- Control Arm
- description
- AI teleconferences without LLM interaction
- interventionNames
- Behavioral: Questionnaires
Primary outcomes (1)
- measure
- Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years. 2. Histologically or cytologically confirmed diagnosis of localized prostate cancer 3. Newly diagnosed and planning to undergo or recently completed a radiation or surgical oncology consult at University of California, San Francisco (UCSF) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. English-speaking and able to participate in study teleconferences 6. Ability to understand and willingness to sign a written informed consent document 7. Access to a device and internet connection sufficient for teleconference participation Exclusion Criteria: 1. Prior definitive treatment for prostate cancer (e.g., surgery, radiation, or systemic therapy) 2. Cognitive, sensory, or language impairment that would interfere with the ability to understand, participate in, or complete the study procedures 3. Inability or unwillingness to participate in two study-related teleconferences 4. Current enrollment in another interventional clinical trial that may interfere with study participation 5. Inability to comply with protocol requirements (e.g., completing surveys or using the information-tracking log)
References
Publications (0)
Data not yet available
No reference posted for this study.