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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-02050 | Registry Identifier | NCI Trial ID |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Lead-in Phase | Experimental | 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. |
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| Interventional (Immediate Access) | Experimental | 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. |
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| Control (Delayed Access) | Experimental | Participants will be given access to OpenEvidence CareConnect for 3 months 90 days after enrollment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey (Participant) | Other | Participants will complete surveys to evaluate their experience using OpenEvidence CareConnect RAG LLM tool. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean score of Safety and Risk Assessment (Lead-in and Provider) | Safety and Risk Assessment evaluates safety concerns based on provider responses using a 5-point Likert scale. | Up to 90 months |
| Mean score of Provider Assessment of AI patient Education Tool Survey (Provider) | 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). | Up to 180 days |
| Mean score of Assessment of Answer Accuracy and Content Appropriateness (Provider) | Provider will evaluate participant questions, answer accuracy and content provided within the OpenEvidence using 3-point scales. | Uup to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean score of AI Tool Experience survey (Participant) | The AI Tool Experience Survey is a 40-question instrument to assess participants' perceptions of usability, usefulness, clinical integration, and support for shared decision-making. Each item is rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). | Up to 180 days |
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Inclusion Criteria:
Females or males ages 18 and over.
Patients must have either:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivy Ow | Contact | 877-827-3222 | Ivy.Wong@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Melisko, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Participants assigned to the Waitlist Control arm will be permitted to crossover to the Intervention arm after 3 months.
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| OpenEvidence CareConnect | Other | Retrieval-Augmented Generation (RAG) Large Language Model (LLM) tool |
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| Survey (Provider) | Other | The provider will complete a survey to assess OpenEvidence CareConnect RAG LLM tool's usefulness and the quality of its patient education communication. |
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| Mean score of Medical Information Experience Survey (Participant) | Medical Information Experience Survey is a 13-question instrument to evaluate how participants access and engage with medical information. Questions are measured using a 5-point Likert scale. | up to 180 days |
| Mean Change of Score of Patient AI Tool Experience Survey (Participant) | The AI Tool Experience Survey is a 40-question instrument to assess participants' perceptions of usability, usefulness, clinical integration, and support for shared decision-making. Each item is rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Comparisons of survey responses between the immediate and delayed access groups will be reported. | up to 180 days |
| Mean Change of Score of Medical Information Experience Survey (Participant) | Medical Information Experience Survey is a 13-question instrument evaluates how participants access and engage with medical information. Questions are measured using a 5-point Likert scale. Comparisons of survey responses between the immediate and delayed access groups will be reported. | Up to 180 days |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |