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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: UCSF Genitourinary Medical Oncology Recruitment
- Numéro de téléphone: 877-827-3222
- E-mail: GUTrials@ucsf.edu
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94143
- University of California, San Francisco
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Contact:
- UCSF Genitourinary Medical Oncology Recruitment
- Numéro de téléphone: 877-827-3222
- E-mail: GUTrials@ucsf.edu
-
Chercheur principal:
- Julian Hong, MD, MS
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Comparateur placebo: Control Arm
AI teleconferences without LLM interaction |
Participant and clinicians will complete questionnaires |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean differences on SDM-Q-9 and SDM-Q-Doc - Patient- and Provider-Perceived Shared Decision Making
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Julian Hong, MD, MS, University of California, San Francisco
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Tumeurs génitales, homme
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Tumeurs prostatiques
- Qualité des soins de santé, accès et évaluation
- Techniques d'investigation
- Méthodes épidémiologiques
- Collecte de données
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Santé publique
- Environnement et santé publique
- Enquêtes et questionnaires
Autres numéros d'identification d'étude
- 26558
- NCI-2026-06916 (Identificateur de registre: NCI Clinical Trials Reporting System (CTRP))
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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