Improving thoracic surgical care with remote electronic symptom monitoring
Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)
We will try remote electronic symptom monitoring (ePROs) for adults having major thoracic surgery to see if it helps catch complications earlier and reduce serious problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06075316 on ClinicalTrials.gov |
What this trial studies
This single-site, non-randomized study implements perioperative electronic patient-reported outcomes (ePROs) monitoring in adults undergoing major thoracic surgery. Participants complete longitudinal web-based, IVR, or staff-administered surveys about symptoms and physical function before and after surgery, and concerning responses generate automated alerts to providers. The study emphasizes implementation measures and barriers to routine use of ePROs rather than randomized effectiveness comparisons. Outcomes include detection of postoperative complications, healthcare utilization such as readmissions, and feasibility and acceptability metrics.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who speak English or Spanish, can complete web-based or IVR symptom surveys, are scheduled for major thoracic surgery requiring an overnight stay, and will be discharged home from the thoracic service.
Not a fit: Patients undergoing only minor thoracic procedures, those unable to communicate in English or Spanish, people with dementia or psychiatric conditions that prevent survey completion, or those not discharged home are unlikely to benefit.
Why it matters
Potential benefit: If successful, ePRO monitoring could detect complications earlier, enabling quicker treatment, fewer readmissions, and improved recovery.
How similar studies have performed: Previous studies have shown ePRO monitoring is feasible for thoracic surgery patients and providers, but large real-world effectiveness data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Gita Mody, MD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Amanda Gentry
- Email: Amanda_gentry@med.unc.edu
- Phone: (336) 655-7743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.