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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: UCSF Genitourinary Medical Oncology Recruitment
- Telefoonnummer: 877-827-3222
- E-mail: GUTrials@ucsf.edu
Studie Locaties
-
-
California
-
San Francisco, California, Verenigde Staten, 94143
- University of California, San Francisco
-
Contact:
- UCSF Genitourinary Medical Oncology Recruitment
- Telefoonnummer: 877-827-3222
- E-mail: GUTrials@ucsf.edu
-
Hoofdonderzoeker:
- Julian Hong, MD, MS
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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-vergelijker: Control Arm
AI teleconferences without LLM interaction |
Participant and clinicians will complete questionnaires |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean differences on SDM-Q-9 and SDM-Q-Doc - Patient- and Provider-Perceived Shared Decision Making
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Julian Hong, MD, MS, University of California, San Francisco
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Genitale ziekten
- Genitale neoplasmata, mannelijk
- Urogenitale neoplasmata
- Neoplasmata per site
- Neoplasmata
- Genitale ziekten, man
- Prostaat Ziekten
- Mannelijke urogenitale ziekten
- Prostaatneoplasmata
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Onderzoekstechnieken
- Epidemiologische methoden
- Gegevensverzameling
- Evaluatiemechanismen voor gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Volksgezondheid
- Milieu en volksgezondheid
- Enquêtes en vragenlijsten
Andere studie-ID-nummers
- 26558
- NCI-2026-06916 (Register-ID: NCI Clinical Trials Reporting System (CTRP))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .