Generative AI Patient Education Module for Breast Oncology

NCT07512271 | Not Yet Recruiting DMC

• 2 other identifiers: 257517NCI-2026-02050
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

Artificial Intelligence (AI); Digital Health

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Mean score of AI Tool Experience survey (Participant)

  Up to 180 days

• Mean score of Medical Information Experience Survey (Participant)

  up to 180 days

• Mean Change of Score of Patient AI Tool Experience Survey (Participant)

  up to 180 days

• Mean Change of Score of Medical Information Experience Survey (Participant)

  Up to 180 days

Study Arms (3)

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.

Other: Survey (Participant); Other: OpenEvidence CareConnect; Other: Survey (Provider)

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.

Other: Survey (Participant); Other: OpenEvidence CareConnect; Other: Survey (Provider)

Control (Delayed Access)

EXPERIMENTAL

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

Other: Survey (Participant); Other: OpenEvidence CareConnect; Other: Survey (Provider)

Interventions

Survey (Participant) OTHER

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

Control (Delayed Access); Interventional (Immediate Access); Safety Lead-in Phase

OpenEvidence CareConnect OTHER

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

Control (Delayed Access); Interventional (Immediate Access); Safety Lead-in Phase

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.

Control (Delayed Access); Interventional (Immediate Access); Safety Lead-in Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindication to any study-related procedure or assessment.
• Cognitive impairment that would interfere with tool usage or survey completion

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michelle Melisko, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivy Ow

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants assigned to the Waitlist Control arm will be permitted to crossover to the Intervention arm after 3 months.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)