Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Michelle Melisko, MD
Headshot of Michelle Melisko
Michelle Melisko

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Keywords

Breast Cancer, Metastatic Breast Cancer, Carcinoma of the Breast, Artificial Intelligence (AI), Digital Health, Breast Neoplasms, Surveys and Questionnaires, OpenEvidence CareConnect

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

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

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Michelle Melisko, MD
    Dr. Michelle E. Melisko is a cancer specialist with expertise in breast cancer treatment and research. She is interested in testing new chemotherapy combinations, biological therapies and immunotherapies for breast cancer, with a particular focus on treatment of cancer that has spread to the brain.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07512271
Study Type
Interventional
Participants
Expecting 35 study participants
Last Updated