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NCT Number: NCT07836933

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Patient Education as Topic Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

PRIMARY OBJECTIVE:

I. 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.

SECONDARY OBJECTIVES:

I. 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.

EXPLORATORY OBJECTIVES:

I. To identify qualitative themes and usage patterns in patient interactions with the LLM.

II. To evaluate resource utilization based on information-seeking behavior logs collected during follow-up.

OUTLINE: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Questionnaires

Behavioral

Participant and clinicians will complete questionnaires

Primary outcomes

  1. Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information

    Time frame: Up to 2 days

    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.

Secondary outcomes

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

    Time frame: Day 21

    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.

  2. Mean differences on NCCN Distress Thermometer - Patient-Reported Distress

    Time frame: Up to 21 days

    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.

  3. Patient-Provider Concordance in Shared Decision Making

    Time frame: Day 21

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: COUNSEL

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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