This study is not yet accepting patients

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

a study on Prostate Cancer Education as Topic

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Julian Hong, MD, MS

Description

Summary

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.

Details

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Keywords

Prostate Cancer, Prostatic Neoplasms, Patient Education as Topic, Artificial Intelligence, Surveys and Questionnaires, AI-guided COUNSEL Intervention

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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)

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07836933
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated