Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07512271

Generative AI Patient Education Module for Breast Oncology

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Carcinoma of the Breast Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey (Participant)

Other

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

OpenEvidence CareConnect

Other

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

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.

Primary outcomes

  1. Mean score of Safety and Risk Assessment (Lead-in and Provider)

    Time frame: Up to 90 months

    Safety and Risk Assessment evaluates safety concerns based on provider responses using a 5-point Likert scale.

  2. Mean score of Provider Assessment of AI patient Education Tool Survey (Provider)

    Time frame: Up to 180 days

    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).

  3. Mean score of Assessment of Answer Accuracy and Content Appropriateness (Provider)

    Time frame: Uup to 180 days

    Provider will evaluate participant questions, answer accuracy and content provided within the OpenEvidence using 3-point scales.

Secondary outcomes

  1. Mean score of AI Tool Experience survey (Participant)

    Time frame: Up to 180 days

    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).

  2. Mean score of Medical Information Experience Survey (Participant)

    Time frame: up to 180 days

    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.

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

    Time frame: up to 180 days

    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.

  4. Mean Change of Score of Medical Information Experience Survey (Participant)

    Time frame: Up to 180 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivy Ow

CONTACT

[email protected]

877-827-3222

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Accuracy and Effect of Prescribed Generative AI Patient Education Module Within Breast Oncology Care

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.