AI Patient Education for Breast Cancer

Overseen By Ivy Ow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Michelle Melisko, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

I have Stage IV breast cancer needing a treatment change, or Stage I-III diagnosed in 6 months.

Basic computer literacy and regular internet access at home

Exclusion Criteria

Contraindication to any study-related procedure or assessment

I do not have cognitive problems that prevent me from using tools or completing surveys.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in Phase

Participants receive access to OpenEvidence CareConnect for safety evaluation

3 months

Regular assessments

Intervention Phase

Participants receive immediate access to OpenEvidence CareConnect and complete surveys

3 months

Surveys and assessments throughout

Control Phase

Participants on the waitlist receive delayed access to OpenEvidence CareConnect

3 months

Surveys and assessments throughout

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Generative AI Patient Education Module

How Is the Trial Designed?

Group I: Safety Lead-in Phase Experimental Treatment 3 Interventions

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.

Group II: Interventional (Immediate Access) Experimental Treatment 3 Interventions

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.

Group III: Control (Delayed Access) Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+