ThoracicNCT06075316
Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
A study testing Symptom monitoring in people with Thoracic, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a single-site, non-randomized study on the outcomes of remote real-time "ePRO monitoring" in thoracic surgery patients. ePRO monitoring is a health information technology intervention comprised of delivering longitudinal electronic patient-reported outcome (ePRO) surveys (e.g., on symptoms, and physical… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thoracic
- What is being tested?
- Symptom monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 31 Mar 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients participating in ePRO monitoring must meet the following inclusion criteria to participate in this study:
- 18 years or older
- English or Spanish speaking
- Able to complete a web-based, telephonic (IVR), or CRA (or other IRB-approved research team member)-administrated symptom survey
- Planned to undergo major thoracic surgery (involving chest wall incisions and overnight admission)
- Discharged from the thoracic surgery service
- Discharged to home
Who cannot join
- All patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation:
- Not completing planned surgery within 3 months of obtaining informed consent
- Inability to understand English or Spanish
- Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
- Dementia, altered mental status, or any psychiatric condition determined by the thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.
- Current incarceration
- Pregnancy
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
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Amanda Gentry, 919-966-3381, amanda_gentry@med.unc.edu
MPH
About this study
This is a single-site, non-randomized study on the outcomes of remote real-time "ePRO monitoring" in thoracic surgery patients. ePRO monitoring is a health information technology intervention comprised of delivering longitudinal electronic patient-reported outcome (ePRO) surveys (e.g., on symptoms, and physical functioning) coupled with automated provider alerts for concerning survey responses.
Read the detailed description
Thoracic surgery patients are at high risk for severe complications post-surgery, such as respiratory failure, empyema, wound problems, and even mortality. Patients with complications may need readmission and invasive management. Usual care may not capture the symptoms of surgery complications. Well-designed remote monitoring of postoperative patients may enable early intervention and lower the risk of severe complications.
This study evaluates the implementation and effectiveness of perioperative electronic patient-reported outcomes (ePROs) monitoring in thoracic surgery patients. Previous studies demonstrated the feasibility of ePROs monitoring by thoracic surgery patients and providers. This study will explore barriers to implementation before real-world effectiveness studies.
- Conditions
- Thoracic
- Being tested
- Symptom monitoring
- Keywords
- Electronic Patient-Reported Outcome, Patient-Reported Outcome, thoracic surgery, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom monitoringOther
Alerts will be sent to providers via email and/or the electronic medical record at pre-specified response thresholds. Providers will be instructed to respond to and document the management of alerts per their clinical routine.
| Study group | Role | What they receive |
|---|---|---|
| ePRO monitoring | Other | Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys. Receives: Other: Symptom monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of ePRO monitoring
Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.
Measured: Months 4 through 6 after implementation of the study
Adoption of ePRO monitoring
Percentage of ePRO monitoring alerts sent that result in clinical action by providers within 1 week of delivery
Measured: Months 4 through 6 after implementation of the study
Patient-level Uptake
the percentage of enrolled patients who participate in >=1 ePRO survey.
Measured: Months 4 through 6 after implementation of the study
Overall Reach of ePRO monitoring
Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.
Measured: End of study
Secondary outcomes (9)
Complication Rate
Percentage of participants with severe complications (Clavien-Dindo grade >=3)
Measured: Baseline through 30 days post-discharge
Emergency department visit at 30 days
Percentage of participants with an emergency department visit
Measured: Baseline through 30 days post-discharge
Emergency department visit at 90 days
Percentage of participants with an emergency department visit
Measured: Baseline through 90 days post-discharge
Readmission at 30 days
Percentage participants readmitted to a hospital
Measured: Baseline through 30 days post-discharge
Readmission at 90 days
Percentage participants readmitted to a hospital
Measured: Baseline through 90 days post-discharge
Mortality at 30 days
Percentage participants who died
Measured: Baseline through 30 days
Mortality at 90 days
Percentage participants who died
Measured: Baseline through 90 days
Patient Alert Rate
Percentage of all patients who trigger at least 1 alert.
Measured: Baseline through 90 days
Alert Rate
Percentage of all ePRO surveys that trigger an alert
Measured: Baseline through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start14 Nov 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- The participants will have their alerts sent to the clinicians when concerning symptoms are reported.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gita Mody, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075316
- Sponsor's protocol ID
- LCCC 2141
- Other IDs
- 1K23HL157765-01A1
- Status last verified
- Nov 2026
- First submitted
- 3 Oct 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan as of now to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
- ClinicalTrials.gov ID
- NCT06075316
- Acronym / sponsor ID
- LCCC 2141
- Conditions
- Thoracic
- Keywords
- Electronic Patient-Reported Outcome, Patient-Reported Outcome, thoracic surgery, complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Oct 2023 (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 single-site, non-randomized study on the outcomes of remote real-time "ePRO monitoring" in thoracic surgery patients. ePRO monitoring is a health information technology intervention comprised of delivering longitudinal electronic patient-reported outcome (ePRO) surveys (e.g., on symptoms, and physical functioning) coupled with automated provider alerts for concerning survey responses.
Detailed description
Thoracic surgery patients are at high risk for severe complications post-surgery, such as respiratory failure, empyema, wound problems, and even mortality. Patients with complications may need readmission and invasive management. Usual care may not capture the symptoms of surgery complications. Well-designed remote monitoring of postoperative patients may enable early intervention and lower the risk of severe complications.
This study evaluates the implementation and effectiveness of perioperative electronic patient-reported outcomes (ePROs) monitoring in thoracic surgery patients. Previous studies demonstrated the feasibility of ePROs monitoring by thoracic surgery patients and providers. This study will explore barriers to implementation before real-world effectiveness studies.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will have their alerts sent to the clinicians when concerning symptoms are reported.
| Arm | Type | Receives |
|---|---|---|
| ePRO monitoring | Other | Other: Symptom monitoringThoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients participating in ePRO monitoring must meet the following inclusion criteria to participate in this study:
- 18 years or older
- English or Spanish speaking
- Able to complete a web-based, telephonic (IVR), or CRA (or other IRB-approved research team member)-administrated symptom survey
- Planned to undergo major thoracic surgery (involving chest wall incisions and overnight admission)
Key exclusion criteria (7 listed)
- All patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation:
- Not completing planned surgery within 3 months of obtaining informed consent
- Inability to understand English or Spanish
- Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
- Dementia, altered mental status, or any psychiatric condition determined by the thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.
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 |
|---|---|---|
| Symptom monitoringAlerts will be sent to providers via email and/or the electronic medical record at pre-specified response thresholds. Providers will be instructed to respond to and document the management of alerts per their clinical routine. | Other | ePRO monitoring |
Primary outcome
Reach of ePRO monitoring
Time frame: Months 4 through 6 after implementation of the study
Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.
Adoption of ePRO monitoring
Time frame: Months 4 through 6 after implementation of the study
Percentage of ePRO monitoring alerts sent that result in clinical action by providers within 1 week of delivery
Patient-level Uptake
Time frame: Months 4 through 6 after implementation of the study
the percentage of enrolled patients who participate in >=1 ePRO survey.
Overall Reach of ePRO monitoring
Time frame: End of study
Percentage of eligible thoracic surgery patients enrolling in ePRO monitoring.
9 secondary outcomes
Complication Rate
Time frame: Baseline through 30 days post-discharge
Emergency department visit at 30 days
Time frame: Baseline through 30 days post-discharge
Emergency department visit at 90 days
Time frame: Baseline through 90 days post-discharge
Readmission at 30 days
Time frame: Baseline through 30 days post-discharge
Readmission at 90 days
Time frame: Baseline through 90 days post-discharge
Mortality at 30 days
Time frame: Baseline through 30 days
Mortality at 90 days
Time frame: Baseline through 90 days
Patient Alert Rate
Time frame: Baseline through 90 days
Alert Rate
Time frame: Baseline through 90 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 5 Nov 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan as of now to make IPD available to other researchers.
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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.
Gita Mody, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom monitoring in people with Thoracic, run by UNC Lineberger Comprehensive Cancer Center 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 7 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 5 Nov 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 Amanda Gentry ((336) 655-7743, Amanda_gentry@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of ePRO monitoring (time frame: Months 4 through 6 after implementation of the study). The study lists 4 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 5 Nov 2026.