Recruiting

ePRO Monitoring

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06075316

Conditions

Thoracic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Symptom monitoring

Study Details

Brief 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 functioning) coupled with automated provider alerts for concerning survey responses.

Conditions

Thoracic

Study ID

NCT06075316

Start date

Nov 14, 2023

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients participating in ePRO monitoring must meet the following inclusion criteria to participate in this study:

1. 18 years or older
2. English or Spanish speaking
3. Able to complete a web-based, telephonic (IVR), or CRA (or other IRB-approved research team member)-administrated symptom survey
4. Planned to undergo major thoracic surgery (involving chest wall incisions and overnight admission)
5. Discharged from the thoracic surgery service
6. Discharged to home

Exclusion Criteria:

All patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation:

1. Not completing planned surgery within 3 months of obtaining informed consent
2. Inability to understand English or Spanish
3. Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)
4. 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.
5. Current incarceration
6. Pregnancy

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: ePRO monitoring

Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys.

Interventions

Symptom monitoring

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.

Primary outcome measure

  • Reach of ePRO monitoring [ Time Frame: Months 4 through 6 after implementation of the study ]
  • Adoption of ePRO monitoring [ Time Frame: Months 4 through 6 after implementation of the study ]
  • Patient-level Uptake [ Time Frame: Months 4 through 6 after implementation of the study ]
  • Overall Reach of ePRO monitoring [ Time Frame: End of study ]

Central Contacts and Locations

Central contacts

Amanda Gentry

(336) 655-7743Amanda_gentry@med.unc.edu

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Amanda Gentry

919-966-3381amanda_gentry@med.unc.edu

Principal Investigator:

Gita Mody, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Electronic Patient-Reported Outcome
  • Patient-Reported Outcome
  • thoracic surgery
  • complications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-07-16.