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Purpose

This study evaluates the safety, accuracy, and impact of an artificial intelligence (AI) tool designed to support patient education in breast cancer care for breast oncology patients under selected physicians care within the University of California, San Francisco breast cancer center and affiliate sites.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Females or males ages 18 and over. 2. Patients must have either: 1. Stage IV breast cancer facing a treatment change and are expected to have follow-up visits at least once every three months, or 2. Stage I-III breast cancer diagnosed within the past 6 months. 3. Basic computer literacy and regular internet access at home. 4. Able to understand study procedures and to comply with them for the entire length of the study. 5. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

  1. Contraindication to any study-related procedure or assessment. 2. Cognitive impairment that would interfere with tool usage or survey completion

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Participants assigned to the Waitlist Control arm will be permitted to crossover to the Intervention arm after 3 months.
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Safety Lead-in Phase 		Participants will receive access to OpenEvidence CareConnect a Retrieval-Augmented Generation (RAG) Large Language Model (LLM) tool that provides general health and breast cancer-specific information for 3 months.
  • Other: Survey (Participant)
    Participants will complete surveys to evaluate their experience using OpenEvidence CareConnect RAG LLM tool.
  • Other: OpenEvidence CareConnect
    Retrieval-Augmented Generation (RAG) Large Language Model (LLM) tool
  • Other: Survey (Provider)
    The provider will complete a survey to assess OpenEvidence CareConnect RAG LLM tool's usefulness and the quality of its patient education communication.
Experimental
Interventional (Immediate Access) 		Participants will be given immediate access to OpenEvidence CareConnect for up to 3 months and complete surveys regarding use of tool. Participants are then followed up for an additional 3 months.
  • Other: Survey (Participant)
    Participants will complete surveys to evaluate their experience using OpenEvidence CareConnect RAG LLM tool.
  • Other: OpenEvidence CareConnect
    Retrieval-Augmented Generation (RAG) Large Language Model (LLM) tool
  • Other: Survey (Provider)
    The provider will complete a survey to assess OpenEvidence CareConnect RAG LLM tool's usefulness and the quality of its patient education communication.
Experimental
Control (Delayed Access) 		Participants will be given access to OpenEvidence CareConnect for 3 months 90 days after enrollment
  • Other: Survey (Participant)
    Participants will complete surveys to evaluate their experience using OpenEvidence CareConnect RAG LLM tool.
  • Other: OpenEvidence CareConnect
    Retrieval-Augmented Generation (RAG) Large Language Model (LLM) tool
  • Other: Survey (Provider)
    The provider will complete a survey to assess OpenEvidence CareConnect RAG LLM tool's usefulness and the quality of its patient education communication.

Recruiting Locations

University of California, San Francisco
San Francisco, California 94143
Contact:
Ivy Ow
877-827-3222
Ivy.Wong@ucsf.edu

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

Ivy Ow
877-827-3222
Ivy.Wong@ucsf.edu

Detailed Description

PRIMARY OBJECTIVES: I. Lead-in period: To evaluate the safety of the OpenEvidence CareConnect a Retrieval-Augmented Generation (RAG) Large Language Model (LLM) tool during the initial lead-in phase in patients with metastatic breast cancer. II. To evaluate the clinical accuracy and appropriateness of the OpenEvidence CareConnect RAG LLM tool in delivering general health and breast cancer-specific information. SECONDARY OBJECTIVES: I. To assess patient perceptions of the AI tool's helpfulness, alignment with other information sources, and its impact on communication with their oncology care team. II. To evaluate provider perceptions of the tool's usefulness and impact on communication and the quality of patient education. III. To compare patient experiences and perceptions between immediate access and delayed access to the AI educational tool. EXPLORATORY OBJECTIVES: I. To evaluate the changes in inter-visit communication between patient and care team with and without access to the AI tool. II. To understand patient concerns and educational needs related to breast cancer diagnosis and treatment. OUTLINE: The first 5 participants will be assigned to the Lead-In Phase. After which, the next 30 participants will be randomized to either an Intervention arm or a Waitlist Control arm. Participants on the Waitlist Control arm will cross over after 3 months to the Intervention arm. Surveys and provider assessments occur throughout, and adherence and safety are monitored during the lead-in. Each participant will be on study for approximately 6 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.