Cancer Oriented Understanding and Navigation Via Supportive and Educational Language Models (COUNSEL)

NCT07836933 | Not Yet Recruiting

• 2 other identifiers: 26558NCI-2026-06916
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer; Prostatic Neoplasms; Patient Education as Topic

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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/no 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

Secondary Outcomes (3)

• Mean differences on SDM-Q-9 and SDM-Q-Doc - Patient- and Provider-Perceived Shared Decision Making

  Day 21

• Mean differences on NCCN Distress Thermometer - Patient-Reported Distress

  Up to 21 days

• Patient-Provider Concordance in Shared Decision Making

  Day 21

Study Arms (2)

Intervention Arm

EXPERIMENTAL

AI teleconferences with Large Language Model (LLM) interaction

Behavioral: AI-guided COUNSEL Intervention; Behavioral: Questionnaires

Control Arm

PLACEBO COMPARATOR

AI teleconferences without LLM interaction

Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

Participant and clinicians will complete questionnaires

Control Arm; Intervention Arm

AI-guided COUNSEL Intervention BEHAVIORAL

An AI-guided, interactive educational tool that allows participants to interact with a large language model (LLM) will be delivered via teleconference.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Histologically or cytologically confirmed diagnosis of localized prostate cancer
• Newly diagnosed and planning to undergo or recently completed a radiation or surgical oncology consult at University of California, San Francisco (UCSF)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• English-speaking and able to participate in study teleconferences
• Ability to understand and willingness to sign a written informed consent document
• Access to a device and internet connection sufficient for teleconference participation

You may not qualify if:

• Prior definitive treatment for prostate cancer (e.g., surgery, radiation, or systemic therapy)
• Cognitive, sensory, or language impairment that would interfere with the ability to understand, participate in, or complete the study procedures
• Inability or unwillingness to participate in two study-related teleconferences
• Current enrollment in another interventional clinical trial that may interfere with study participation
• Inability to comply with protocol requirements (e.g., completing surveys or using the information-tracking log)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Julian Hong, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UCSF Genitourinary Medical Oncology Recruitment

CONTACT

877-827-3222; GUTrials@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)