Cancer Oriented Understanding and Navigation Via Supportive and Educational Language Models (COUNSEL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information
Study Overview
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Intervention Arm
AI teleconferences with Large Language Model (LLM) interaction
Intervention: Questionnaires (Behavioral)
Control Arm
AI teleconferences without LLM interaction
Intervention: Questionnaires (Behavioral)
Intervention Arm
AI teleconferences with Large Language Model (LLM) interaction
Intervention: AI-guided COUNSEL Intervention (Behavioral)
Outcomes
Primary Outcomes
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
- 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)