Breast CancerNCT07512271
Generative AI Patient Education Module for Breast Oncology
A study testing Survey (Participant), OpenEvidence CareConnect and Survey (Provider) in people with Breast Cancer and Metastatic Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Carcinoma of the Breast
- What is being tested?
- Survey (Participant), OpenEvidence CareConnect and Survey (Provider)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindication to any study-related procedure or assessment.
- Cognitive impairment that would interfere with tool usage or survey completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Ivy Ow, 877-827-3222, Ivy.Wong@ucsf.edu
cancertrials@ucsf.edu
About this study
Official title: Accuracy and Effect of Prescribed Generative AI Patient Education Module Within Breast Oncology Care
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Being tested
- Survey (Participant), OpenEvidence CareConnect, Survey (Provider)
- Keywords
- Artificial Intelligence (AI), Digital Health
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey (Participant)Other
Participants will complete surveys to evaluate their experience using OpenEvidence CareConnect RAG LLM tool.
OpenEvidence CareConnectOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Survey (Participant); Other: OpenEvidence CareConnect; Other: Survey (Provider) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Uup to 180 days
Secondary outcomes (4)
Mean score of AI Tool Experience survey (Participant)
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).
Measured: Up to 180 days
Mean score of Medical Information Experience Survey (Participant)
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.
Measured: up to 180 days
Mean Change of Score of Patient AI Tool Experience Survey (Participant)
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.
Measured: up to 180 days
Mean Change of Score of Medical Information Experience Survey (Participant)
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.
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start14 Jul 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants assigned to the Waitlist Control arm will be permitted to crossover to the Intervention arm after 3 months.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Melisko, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512271
- Sponsor's protocol ID
- 257517
- Other IDs
- NCI-2026-02050
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Effect of Prescribed Generative AI Patient Education Module Within Breast Oncology Care
- ClinicalTrials.gov ID
- NCT07512271
- Acronym / sponsor ID
- 257517
- Keywords
- Artificial Intelligence (AI), Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants assigned to the Waitlist Control arm will be permitted to crossover to the Intervention arm after 3 months.
| Arm | Type | Receives |
|---|---|---|
| Safety Lead-in Phase | Experimental | Other: Survey (Participant), Other: OpenEvidence CareConnect, Other: Survey (Provider)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. |
| Interventional (Immediate Access) | Experimental | Other: Survey (Participant), Other: OpenEvidence CareConnect, Other: Survey (Provider)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. |
| Control (Delayed Access) | Experimental | Other: Survey (Participant), Other: OpenEvidence CareConnect, Other: Survey (Provider)Participants will be given access to OpenEvidence CareConnect for 3 months 90 days after enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females or males ages 18 and over.
- Patients must have either:
- 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.
Key exclusion criteria (2 listed)
- Contraindication to any study-related procedure or assessment.
- Cognitive impairment that would interfere with tool usage or survey completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey (Participant)Participants will complete surveys to evaluate their experience using OpenEvidence CareConnect RAG LLM tool. | Other | Control (Delayed Access), Interventional (Immediate Access), Safety Lead-in Phase |
| OpenEvidence CareConnectRetrieval-Augmented Generation (RAG) Large Language Model (LLM) tool | Other | Control (Delayed Access), Interventional (Immediate Access), Safety Lead-in Phase |
| Survey (Provider)The provider will complete a survey to assess OpenEvidence CareConnect RAG LLM tool's usefulness and the quality of its patient education communication. | Other | Control (Delayed Access), Interventional (Immediate Access), Safety Lead-in Phase |
Primary outcome
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.
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).
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.
4 secondary outcomes
Mean score of AI Tool Experience survey (Participant)
Time frame: Up to 180 days
Mean score of Medical Information Experience Survey (Participant)
Time frame: up to 180 days
Mean Change of Score of Patient AI Tool Experience Survey (Participant)
Time frame: up to 180 days
Mean Change of Score of Medical Information Experience Survey (Participant)
Time frame: Up to 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Melisko, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey (Participant), OpenEvidence CareConnect and Survey (Provider) in people with Breast Cancer and Metastatic Breast Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivy Ow (877-827-3222, Ivy.Wong@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score of Safety and Risk Assessment (Lead-in and Provider) (time frame: Up to 90 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.