Recruiting

Artificial Intelligence

Sponsor:

UCLA

Code:

NCT07512271

Conditions

Breast Cancer

Metastatic Breast Cancer

Carcinoma of the Breast

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey (Participant)

OpenEvidence CareConnect

Survey (Provider)

Study Details

Brief summary:

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

Breast Cancer

Metastatic Breast Cancer

Carcinoma of the Breast

Study ID

NCT07512271

Start date

Jul 14, 2026

Status verified date

Aug, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

experimental: Control (Delayed Access)

Participants will be given access to OpenEvidence CareConnect for 3 months 90 days after enrollment

Interventions

Survey (Participant)

Participants will complete surveys to evaluate their experience using OpenEvidence CareConnect RAG LLM tool.

OpenEvidence CareConnect

Retrieval-Augmented Generation (RAG) Large Language Model (LLM) tool

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ivy Ow

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

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Ivy Ow

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

cancertrials@ucsf.edu

Principal Investigator:

Michelle Melisko, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Artificial Intelligence (AI)
  • Digital Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-06.