Advanced CancerBRIDGE-SICNCT07147023
Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication
A study testing LLM SIC Summary Email in people with Advanced Cancer and Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The goal of this study is to test the accuracy of Large Language Model-generated serious illness communication (SIC) summaries, the feasibility of delivering the SIC summaries, and to collect perspectives on the SIC summaries from clinicians and participants with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Cancer, End of Life
- What is being tested?
- LLM SIC Summary Email
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2025to 15 Apr 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
Participant Inclusion Criteria:
- Dana-Farber Cancer Institute participants
- Admission to an inpatient solid tumor medical oncology service at BWH (including beds that are considered to be DFCI beds within BWH)
- Age ≥ 18 years
- Mortality prediction ≥ 40%
- Admitted on a Sunday after 4pm, Monday or Tuesday before 4pm. These time restrictions are necessary for the workflow of this pragmatic pilot trial, as an individual will need to send out the intervention emails and interview patients approximately 48-72 hours after admission, both of which need to occur during the work week.
Participant Exclusion Criteria:
-Patients with elective inpatient admissions (typically for chemotherapy or other treatments)
Clinician Inclusion Criteria:
-The clinician fills one of the following roles for the enrolled patient:
- inpatient attending on the medical oncology team
- outpatient Dana-Farber medical oncologist
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
The goal of this study is to test the accuracy of Large Language Model-generated serious illness communication (SIC) summaries, the feasibility of delivering the SIC summaries, and to collect perspectives on the SIC summaries from clinicians and participants with cancer. Large Language Models (LLMs) are artificial intelligence programs that can perform various natural language processing tasks.
Read the detailed description
The study will enroll up to 70 Dana-Farber patients admitted to Brigham and Women's hospital who have an elevated mortality prediction at admission. The research study procedures include randomization to intervention or control arms on admission (3:1 intervention to control). For patients in the intervention arm, a large language model query will summarize serious illness communication documentation in their medical record screening from the prior 6 months. A summary of the documentation will be sent to the inpatient and outpatient oncology clinicians within 24 hours of admission; these clinicians will be asked to review the summaries, discuss with the patient and incorporate into care plans as appropriate. For patients with no SIC documented on day 4 of the admission, a second email will be sent. Control patients will receive usual care, which is no email sent to their oncology teams. All patients will be offered to participate in an interview on day 4 of their admission about their communication with their care teams. For patients in both arms, inpatient and outpatient oncology attendings will be sent an email survey regarding SIC for the patient and, if applicable, the utility of the SIC summaries.
- Conditions
- Advanced Cancer, Cancer, End of Life
- Being tested
- LLM SIC Summary Email
- Keywords
- Advanced Cancer, Cancer, Serious Illness, End of Life Care
- Medical subject headings
- Neoplasms, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM SIC Summary EmailOther
A Large Language Model-based platform is integrated with the Health Vision Platform, a HIPAA-compliant, electronic health record data management system. Real-time summaries of prior SIC with be sent to clinicians caring for participants in the intervention arm.
An email will be sent to the inpatient attending and responding clinician encouraging the team to review the SIC summary, discuss care preferences with the patient and ensure care is aligned with preferences and goals. If no SIC documentation is found, the email will instead encourage the outpatient oncologist to share information regarding undocumented SICs that may have occurred, as well as prompt inpatient and outpatient teams to engage the patient in SIC.
For patients with no SIC documentation who are still admitted 72 hours later, the RA will send an additional email prompting SIC or asking the clinician to indicate that an SIC is not appropriate. Patients will also receive standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Group A: LLM-Generated SIC Summary Email | Experimental | 45 participants will be randomized. Participants will have the option of completing a one-time in-person interview with study staff on their perceptions of SIC and the acceptability of LLM-generated summaries of SIC. Receives: Other: LLM SIC Summary Email |
| Group B: Usual Care | No intervention | 15 participants will be randomized and will receive standard oncology care. Participants will have the option of completing a one-time in-person interview with study staff on their perceptions of SIC and the acceptability of LLM-generated summaries of SIC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Illness Conversation (SIC) summary accuracy
Primary outcome: We will assess SIC summary accuracy by reviewing the source documentation for each bullet point of the 5 domains of the SIC summary. The RA will read each bullet point, read the source note for the date cited in the summary and indicate with a 1 (supported) or 0 (not supported) whether the documentation supports the summarized point. If a summarized point is scored as 0, the MPIs will independently review the item and assign a 1 or 0 to indicate whether the unsupported summary could negatively impact patient care. SIC summary accuracy will be determined at the patient level as the proportion of bullet points supported by underlying documentation divided by the total number of bullet points (i.e., a score from 0 to 1). We will determine the average SIC accuracy score across all patients for the study. We will also report the percent of LLM-SIC summary statements that are unsupported and clinically significant and provide qualitative descriptions of these instances.
Measured: 1 week
Secondary outcomes (4)
Feasibility (successful delivery of the intervention)
Feasibility is defined as the successful delivery of the summary email, and will be calculated as the number of participants with successful delivery of the intervention email divided by the total number of intervention participants, with an 80% feasibility threshold.
Measured: 1 week
Clinician Perspectives of Clinical Utility
Clinician perspectives of clinical utility are defined as clinicians' views on the usefulness and relevance of serious illness communication (SIC) and, for intervention-arm clinicians, the LLM-generated SIC summaries for informing participant care. These perspectives will be assessed via structured REDCap surveys sent to both inpatient and outpatient clinicians, with follow-up phone interviews conducted by the research assistants for non-respondents.
Clinician responses to surveys and interview questions will be summarized and stratified by intervention vs control groups. We will compare survey responses between the two study arms using Chisquared and Mann-Whitney U tests for binary and likert items, respectively. Responses to open-ended questions will be qualitatively summarized.
Measured: 1 week
Participant Perspectives on Inpatient and Outpatient Clinician Understanding of their Care Preferences and Acceptability of SIC Summaries
Participant acceptability is defined as participant perceptions of the appropriateness and usefulness of LLM-generated summaries of serious illness conversations (SICs). It will be assessed through structured in-person interviews including the validated "Heard and Understood" questionnaire and open-ended questions regarding the acceptability of SIC summaries and participant-clinician communication.
Participant responses to interview questions will be summarized and stratified by intervention vs control groups. Responses to open-ended questions will be qualitatively summarized.
Measured: 1 week
New Documentation of SIC
New documentation of serious illness communication (SIC) during the index hospitalization is defined as any new note or entry created in the electronic health record (EHR) during the current hospital admission that reflects a discussion of the participant's values, goals, preferences, or prognosis, and meets the standardized codebook criteria for SIC.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start15 Sep 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotta Lindvall, MD, Dana-Farber Cancer Institute
- Investigators
- Charlotta Lindvall, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147023
- Sponsor's protocol ID
- 25-314
- Acronym
- BRIDGE-SIC
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication
- ClinicalTrials.gov ID
- NCT07147023
- Acronym / sponsor ID
- BRIDGE-SIC / 25-314
- Conditions
- Advanced Cancer, Cancer, End of Life
- Keywords
- Advanced Cancer, Cancer, Serious Illness, End of Life Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 28 Aug 2025 (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.
The goal of this study is to test the accuracy of Large Language Model-generated serious illness communication (SIC) summaries, the feasibility of delivering the SIC summaries, and to collect perspectives on the SIC summaries from clinicians and participants with cancer. Large Language Models (LLMs) are artificial intelligence programs that can perform various natural language processing tasks.
Detailed description
The study will enroll up to 70 Dana-Farber patients admitted to Brigham and Women's hospital who have an elevated mortality prediction at admission. The research study procedures include randomization to intervention or control arms on admission (3:1 intervention to control). For patients in the intervention arm, a large language model query will summarize serious illness communication documentation in their medical record screening from the prior 6 months. A summary of the documentation will be sent to the inpatient and outpatient oncology clinicians within 24 hours of admission; these clinicians will be asked to review the summaries, discuss with the patient and incorporate into care plans as appropriate. For patients with no SIC documented on day 4 of the admission, a second email will be sent. Control patients will receive usual care, which is no email sent to their oncology teams. All patients will be offered to participate in an interview on day 4 of their admission about their communication with their care teams. For patients in both arms, inpatient and outpatient oncology attendings will be sent an email survey regarding SIC for the patient and, if applicable, the utility of the SIC summaries.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: LLM-Generated SIC Summary Email | Experimental | Other: LLM SIC Summary Email45 participants will be randomized. Participants will have the option of completing a one-time in-person interview with study staff on their perceptions of SIC and the acceptability of LLM-generated summaries of SIC. |
| Group B: Usual Care | No intervention | –15 participants will be randomized and will receive standard oncology care. Participants will have the option of completing a one-time in-person interview with study staff on their perceptions of SIC and the acceptability of LLM-generated summaries of SIC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| LLM SIC Summary EmailA Large Language Model-based platform is integrated with the Health Vision Platform, a HIPAA-compliant, electronic health record data management system. Real-time summaries of prior SIC with be sent to clinicians caring for participants in the intervention arm. An email will be sent to the inpatient attending and responding clinician encouraging the team to review the SIC summary, discuss care preferences with the patient and ensure care is aligned with preferences and goals. If no SIC documentation is found, the email will instead encourage the outpatient oncologist to share information regarding undocumented SICs that may have occurred, as well as prompt inpatient and outpatient teams to engage the patient in SIC. For patients with no SIC documentation who are still admitted 72 hours later, the RA will send an additional email prompting SIC or asking the clinician to indicate that an SIC is not appropriate. Patients will also receive standard of care. | Other | Group A: LLM-Generated SIC Summary Email |
Primary outcome
Serious Illness Conversation (SIC) summary accuracy
Time frame: 1 week
Primary outcome: We will assess SIC summary accuracy by reviewing the source documentation for each bullet point of the 5 domains of the SIC summary. The RA will read each bullet point, read the source note for the date cited in the summary and indicate with a 1 (supported) or 0 (not supported) whether the documentation supports the summarized point. If a summarized point is scored as 0, the MPIs will independently review the item and assign a 1 or 0 to indicate whether the unsupported summary could negatively impact patient care. SIC summary accuracy will be determined at the patient level as the proportion of bullet points supported by underlying documentation divided by the total number of bullet points (i.e., a score from 0 to 1). We will determine the average SIC accuracy score across all patients for the study. We will also report the percent of LLM-SIC summary statements that are unsupported and clinically significant and provide qualitative descriptions of these instances.
4 secondary outcomes
Feasibility (successful delivery of the intervention)
Time frame: 1 week
Clinician Perspectives of Clinical Utility
Time frame: 1 week
Participant Perspectives on Inpatient and Outpatient Clinician Understanding of their Care Preferences and Acceptability of SIC Summaries
Time frame: 1 week
New Documentation of SIC
Time frame: 1 week
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Charlotta Lindvall, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLM SIC Summary Email in people with Advanced Cancer and Cancer, run by Dana-Farber Cancer Institute at 2 sites 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?
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: under way, not looking for participants, as of the sponsor's last update on 26 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 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Illness Conversation (SIC) summary accuracy (time frame: 1 week). 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 26 Aug 2026.