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Cancer Oriented Understanding and Navigation Via Supportive and Educational Language Models (COUNSEL)

24. september 2026 opdateret af: University of California, San Francisco

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: UCSF Genitourinary Medical Oncology Recruitment
  • Telefonnummer: 877-827-3222
  • E-mail: GUTrials@ucsf.edu

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco
        • Kontakt:
          • UCSF Genitourinary Medical Oncology Recruitment
          • Telefonnummer: 877-827-3222
          • E-mail: GUTrials@ucsf.edu
        • Ledende efterforsker:
          • Julian Hong, MD, MS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥18 years.
  2. Histologically or cytologically confirmed diagnosis of localized prostate cancer
  3. Newly diagnosed and planning to undergo or recently completed a radiation or surgical oncology consult at University of California, San Francisco (UCSF)
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  5. English-speaking and able to participate in study teleconferences
  6. Ability to understand and willingness to sign a written informed consent document
  7. Access to a device and internet connection sufficient for teleconference participation

Exclusion Criteria:

  1. Prior definitive treatment for prostate cancer (e.g., surgery, radiation, or systemic therapy)
  2. Cognitive, sensory, or language impairment that would interfere with the ability to understand, participate in, or complete the study procedures
  3. Inability or unwillingness to participate in two study-related teleconferences
  4. Current enrollment in another interventional clinical trial that may interfere with study participation
  5. Inability to comply with protocol requirements (e.g., completing surveys or using the information-tracking log)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Arm

AI teleconferences with Large Language Model (LLM) interaction
Adfærdsmæssigt: AI-guided COUNSEL Intervention

An AI-guided, interactive educational tool that allows participants to interact with a large language model (LLM) will be delivered via teleconference.

Adfærdsmæssigt: Questionnaires

Participant and clinicians will complete questionnaires
Placebo komparator: Control Arm

AI teleconferences without LLM interaction
Adfærdsmæssigt: Questionnaires

Participant and clinicians will complete questionnaires

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean differences on EORTC QLQ-INFO25 - Patient-Perceived Cancer-Related Information
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean differences on SDM-Q-9 and SDM-Q-Doc - Patient- and Provider-Perceived Shared Decision Making
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Julian Hong, MD, MS, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. oktober 2026

Primær færdiggørelse (Anslået)

30. november 2027

Studieafslutning (Anslået)

30. april 2028

Datoer for studieregistrering

Først indsendt

17. september 2026

Først indsendt, der opfyldte QC-kriterier

17. september 2026

Først opslået (Faktiske)

23. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26558
  • NCI-2026-06916 (Registry Identifier: NCI Clinical Trials Reporting System (CTRP))

Plan for individuelle deltagerdata (IPD)

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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