Breast Cancer, Carcinoma of the Breast, Metastatic Breast Cancer
Conditions
Keywords
Artificial Intelligence (AI), Digital Health
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.
Detailed description
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.
Interventions
OTHERSurvey (Participant)
Participants will complete surveys to evaluate their experience using OpenEvidence CareConnect RAG LLM tool.
OTHEROpenEvidence CareConnect
Retrieval-Augmented Generation (RAG) Large Language Model (LLM) tool
OTHERSurvey (Provider)
The provider will complete a survey to assess OpenEvidence CareConnect RAG LLM tool's usefulness and the quality of its patient education communication.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants assigned to the Waitlist Control arm will be permitted to crossover to the Intervention arm after 3 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean score of Safety and Risk Assessment (Lead-in and Provider) | Up to 90 months | Safety and Risk Assessment evaluates safety concerns based on provider responses using a 5-point Likert scale. |
| Mean score of Provider Assessment of AI patient Education Tool Survey (Provider) | 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). |
| Mean score of Assessment of Answer Accuracy and Content Appropriateness (Provider) | Uup to 180 days | Provider will evaluate participant questions, answer accuracy and content provided within the OpenEvidence using 3-point scales. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean score of AI Tool Experience survey (Participant) | 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). |
| Mean score of Medical Information Experience Survey (Participant) | 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. |
| Mean Change of Score of Patient AI Tool Experience Survey (Participant) | 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. |
| Mean Change of Score of Medical Information Experience Survey (Participant) | 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. |
Countries
United States
Contacts
CONTACTIvy Ow
PRINCIPAL_INVESTIGATORMichelle Melisko, MD
University of California, San Francisco
Outcome results
None listed