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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: UCSF Genitourinary Medical Oncology Recruitment
- Número de teléfono: 877-827-3222
- Correo electrónico: GUTrials@ucsf.edu
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94143
- University of California, San Francisco
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Contacto:
- UCSF Genitourinary Medical Oncology Recruitment
- Número de teléfono: 877-827-3222
- Correo electrónico: GUTrials@ucsf.edu
-
Investigador principal:
- Julian Hong, MD, MS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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 |
|
Comparador de placebos: Control Arm
AI teleconferences without LLM interaction |
Participant and clinicians will complete questionnaires |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean differences on SDM-Q-9 and SDM-Q-Doc - Patient- and Provider-Perceived Shared Decision Making
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julian Hong, MD, MS, University of California, San Francisco
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Neoplasias prostáticas
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Encuestas y cuestionarios
Otros números de identificación del estudio
- 26558
- NCI-2026-06916 (Identificador de registro: NCI Clinical Trials Reporting System (CTRP))
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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