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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: UCSF Genitourinary Medical Oncology Recruitment
- Telefonnummer: 877-827-3222
- E-Mail: GUTrials@ucsf.edu
Studienorte
-
-
California
-
San Francisco, California, Vereinigte Staaten, 94143
- University of California, San Francisco
-
Kontakt:
- UCSF Genitourinary Medical Oncology Recruitment
- Telefonnummer: 877-827-3222
- E-Mail: GUTrials@ucsf.edu
-
Hauptermittler:
- Julian Hong, MD, MS
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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 |
|
Placebo-Komparator: Control Arm
AI teleconferences without LLM interaction |
Participant and clinicians will complete questionnaires |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean differences on SDM-Q-9 and SDM-Q-Doc - Patient- and Provider-Perceived Shared Decision Making
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Julian Hong, MD, MS, University of California, San Francisco
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Genitale Neubildungen, männlich
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen
- Genitalerkrankungen, männlich
- Prostataerkrankungen
- Männliche Urogenitalerkrankungen
- Prostataneoplasmen
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Untersuchungstechniken
- Epidemiologische Methoden
- Datenerfassung
- Gesundheitsbewertungsmechanismen
- Qualität der Gesundheitsversorgung
- Öffentliche Gesundheit
- Umwelt und öffentliche Gesundheit
- Umfragen und Fragebögen
Andere Studien-ID-Nummern
- 26558
- NCI-2026-06916 (Registrierungskennung: NCI Clinical Trials Reporting System (CTRP))
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