NCT07512271 · University of California, San Francisco
Generative AI Patient Education Module for Breast Oncology
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Mean score of Safety and Risk Assessment (Lead-in and Provider)
Time frame: Up to 90 months
Safety and Risk Assessment evaluates safety concerns based on provider responses using a 5-point Likert scale.
Mean score of Provider Assessment of AI patient Education Tool Survey (Provider)
Time frame: Up to 180 days
AI patient Education Tool Survey evaluates clinical accuracy and appropriateness of the OpenEvidence CareConnect tool based on provider responses using a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).
Mean score of Assessment of Answer Accuracy and Content Appropriateness (Provider)
Time frame: Uup to 180 days
Provider will evaluate participant questions, answer accuracy and content provided within the OpenEvidence using 3-point scales.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Females or males ages 18 and over.
- Patients must have either:
- Stage IV breast cancer facing a treatment change and are expected to have follow-up visits at least once every three months, or
- Stage I-III breast cancer diagnosed within the past 6 months.
- Basic computer literacy and regular internet access at home.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
- Contraindication to any study-related procedure or assessment.
- Cognitive impairment that would interfere with tool usage or survey completion
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations