Generative AI Patient Education Module for Breast Oncology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Survey (Participant), OpenEvidence CareConnect, Survey (Provider).
- Who it may be relevant to
- Registry conditions: Breast Cancer, Metastatic Breast Cancer, Carcinoma of the Breast. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Accuracy and Effect of Prescribed Generative AI Patient Education Module Within Breast Oncology Care
Overview
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.
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.
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]
- Mean score of Provider Assessment of AI patient Education Tool Survey (Provider) [Time frame: Up to 180 days]
- Mean score of Assessment of Answer Accuracy and Content Appropriateness (Provider) [Time frame: Uup to 180 days]
Secondary outcome measures (4)
- Mean score of AI Tool Experience survey (Participant) [Time frame: Up to 180 days]
- Mean score of Medical Information Experience Survey (Participant) [Time frame: up to 180 days]
- Mean Change of Score of Patient AI Tool Experience Survey (Participant) [Time frame: up to 180 days]
- Mean Change of Score of Medical Information Experience Survey (Participant) [Time frame: Up to 180 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT07512271 · 257517 · NCI-2026-02050