CancerNCT07735442
BRIDGE-SIC Efficacy Trial
A study testing LLM-generated SIC summary email to clinical teams in people with Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This is a pragmatic, prospective, randomized clinical trial to test the effectiveness of large language model (LLM)-generated serious illness conversation (SIC) summaries delivered to patients' inpatient and outpatient clinicians at the time of hospital admission on the primary outcome of days in the hospital in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- LLM-generated SIC summary email to clinical teams
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2026to 30 Jun 2028
- 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
- DFCI Patients, defined as patients who have a DFCI medical record number.
- Admitted 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 ≥ 25%
- Admitted on a Sunday after 4pm through Friday at 4pm. These time restrictions are necessary for the workflow of this pragmatic pilot trial, as the intervention requires a staff member to send intervention emails during the work week but within <= approximately 18 hours of admission. Accordingly, we will not enroll patients during holiday time periods (e.g., for a Monday holiday, enrollment would start on Monday at 4pm instead of Sunday at 4pm) or on days where staff absences (e.g., illness) preclude enrollment.
Who cannot join
- Patients with elective inpatient admissions (typically for planned administration of chemotherapy or other treatments)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02214
Alexi A Wright, MD.MPH, 617-632-2334, alexi_wright@dfci.harvard.edu
Charlotta J Lindvall, MD PhD, 6175823401, charlotta_lindvall@dfci.harvard.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Alexi A Wright, MD. MPH, 617-632-2334, Alexi_Wright@dfci.harvard.edu
Alexi A Wright, MD, MPH, 6176322334, Alexi_Wright@dfci.harvard.edu
About this study
Official title: Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication (BRIDGE-SIC)
This is a pragmatic, prospective, randomized clinical trial to test the effectiveness of large language model (LLM)-generated serious illness conversation (SIC) summaries delivered to patients' inpatient and outpatient clinicians at the time of hospital admission on the primary outcome of days in the hospital in the next 90 days.
Read the detailed description
The study will automatically enroll up to 600 DFCI patients with solid tumor cancers admitted to BWH inpatient medical oncology services with a predicted 90-day mortality risk of ≥ 25%. Patients will be randomized 1:1 to intervention vs control arms. The intervention arm will receive LLM-generated SIC summaries sent to their clinical teams, prompting incorporation of patient preferences into care plans. The control arm will receive standard of care. Outcomes will be followed for 90 days post-admission. The study uses a waiver of informed consent and HIPAA authorization due to minimal risk and the need for real-time identification and intervention delivery.
- Conditions
- Cancer
- Being tested
- LLM-generated SIC summary email to clinical teams
- Keywords
- Cancer (Solid Tumor)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM-generated SIC summary email to clinical teamsBehavioural
An email containing a summary of prior serious illness conversations, generated by a large language model, is sent to the patient's clinical teams at admission, prompting review and discussion of care preferences.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Intervention Arm | Experimental | An email is sent to patients' inpatient and outpatient clinical teams containing an LLM-generated summary of prior SIC documentation, prompting clinicians to review and discuss care preferences with the patient and align care with patient goals. Receives: Behavioral: LLM-generated SIC summary email to clinical teams |
| Arm 2: Control Arm | No intervention | Patients receive standard of care; SICs may be initiated by patients or clinicians as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days in the Hospital
The number of days in the hospital is defined as the total number of inpatient days, including days from the index hospitalization and any subsequent hospital admissions during the follow-up period.
Measured: 90 days after randomization
Secondary outcomes (1)
Number of Hospital Readmissions
The number of hospital readmissions is defined as the total number of inpatient hospital readmissions, excluding the index hospitalization.
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start4 Aug 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexi A. Wright, MD, Dana-Farber Cancer Institute
- Investigators
- Alexi Wright, MD,MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735442
- Sponsor's protocol ID
- 26-253
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- 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 (BRIDGE-SIC)
- ClinicalTrials.gov ID
- NCT07735442
- Acronym / sponsor ID
- 26-253
- Conditions
- Cancer
- Keywords
- Cancer (Solid Tumor)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Jul 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 is a pragmatic, prospective, randomized clinical trial to test the effectiveness of large language model (LLM)-generated serious illness conversation (SIC) summaries delivered to patients' inpatient and outpatient clinicians at the time of hospital admission on the primary outcome of days in the hospital in the next 90 days.
Detailed description
The study will automatically enroll up to 600 DFCI patients with solid tumor cancers admitted to BWH inpatient medical oncology services with a predicted 90-day mortality risk of ≥ 25%. Patients will be randomized 1:1 to intervention vs control arms. The intervention arm will receive LLM-generated SIC summaries sent to their clinical teams, prompting incorporation of patient preferences into care plans. The control arm will receive standard of care. Outcomes will be followed for 90 days post-admission. The study uses a waiver of informed consent and HIPAA authorization due to minimal risk and the need for real-time identification and intervention delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intervention Arm | Experimental | Behavioral: LLM-generated SIC summary email to clinical teamsAn email is sent to patients' inpatient and outpatient clinical teams containing an LLM-generated summary of prior SIC documentation, prompting clinicians to review and discuss care preferences with the patient and align care with patient goals. |
| Arm 2: Control Arm | No intervention | –Patients receive standard of care; SICs may be initiated by patients or clinicians as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DFCI Patients, defined as patients who have a DFCI medical record number.
- Admitted 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 ≥ 25%
- Admitted on a Sunday after 4pm through Friday at 4pm. These time restrictions are necessary for the workflow of this pragmatic pilot trial, as the intervention requires a staff member to send intervention emails during the work week but within <= approximately 18 hours of admission. Accordingly, we will not enroll patients during holiday time periods (e.g., for a Monday holiday, enrollment would start on Monday at 4pm instead of Sunday at 4pm) or on days where staff absences (e.g., illness) preclude enrollment.
Key exclusion criteria (1 listed)
- Patients with elective inpatient admissions (typically for planned administration of chemotherapy or other treatments)
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-generated SIC summary email to clinical teamsAn email containing a summary of prior serious illness conversations, generated by a large language model, is sent to the patient's clinical teams at admission, prompting review and discussion of care preferences. | Behavioural | Arm 1: Intervention Arm |
Primary outcome
Number of Days in the Hospital
Time frame: 90 days after randomization
The number of days in the hospital is defined as the total number of inpatient days, including days from the index hospitalization and any subsequent hospital admissions during the follow-up period.
1 secondary outcome
Number of Hospital Readmissions
Time frame: 90 days after randomization
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.
Alexi Wright, MD,MPH 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-generated SIC summary email to clinical teams in people with 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?
The sponsor lists 5 inclusion and 1 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 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?
Contact Alexi A Wright, MD, MPH (6176322334, alexi_wright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days in the Hospital (time frame: 90 days after randomization). 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.