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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：UCSF Genitourinary Medical Oncology Recruitment
- 电话号码：877-827-3222
- 邮箱：GUTrials@ucsf.edu
学习地点
-
-
California
-
San Francisco、California、美国、94143
- University of California, San Francisco
-
接触：
- UCSF Genitourinary Medical Oncology Recruitment
- 电话号码：877-827-3222
- 邮箱：GUTrials@ucsf.edu
-
首席研究员：
- Julian Hong, MD, MS
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention Arm
AI teleconferences with Large Language Model (LLM) interaction |
An AI-guided, interactive educational tool that allows participants to interact with a large language model (LLM) will be delivered via teleconference. Participant and clinicians will complete questionnaires |
|
安慰剂比较：Control Arm
AI teleconferences without LLM interaction |
Participant and clinicians will complete questionnaires |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information
大体时间：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. |
Up to 2 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean differences on SDM-Q-9 and SDM-Q-Doc - Patient- and Provider-Perceived Shared Decision Making
大体时间：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. |
Day 21
|
|
Mean differences on NCCN Distress Thermometer - Patient-Reported Distress
大体时间：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. |
Up to 21 days
|
|
Patient-Provider Concordance in Shared Decision Making
大体时间：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. |
Day 21
|
合作者和调查者
调查人员
- 首席研究员：Julian Hong, MD, MS、University of California, San Francisco
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 26558
- NCI-2026-06916 (注册表标识符：NCI Clinical Trials Reporting System (CTRP))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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