N/A
N=113
Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
Thoracic Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04342260 ↗Enrolled (actual)
113
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Quality of Life at 12 Months — 80.97; 84.02 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Monitoring (Other); Passive Monitoring (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life at 12 Months |
80.97; 84.02 | — |
| PRIMARY Lung Cancer Specific Quality of Life at 12 Months |
15.48; 9.52; 21.43; 10.71; 30.95; 21.43 | — |
| PRIMARY PRO Symptom Monitoring Surveys Completed at 3 Months |
61.1; 50.30 | — |
| PRIMARY PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months |
64 | — |
| PRIMARY Barriers and Facilitators of PRO Monitoring After Thoracic Surgery |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Readmission at 3 Months |
6; 7 | — |
| SECONDARY Overall Survival at 12 Months |
47; 47 | — |
Summary
This study is designed to test if patient-reported outcomes with automated reporting to clinicians for remote monitoring of postoperative symptoms is feasible and improves quality of life, health outcomes, and service utilization in thoracic surgery patients. Patients undergoing thoracic surgery will be asked to self-report symptoms for remote monitoring by their care team.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- English speaking
- Able and willing to complete web-based symptom survey
- Be presenting for inpatient thoracic surgery
Exclusion Criteria
- Not completing planned surgery within 3 months of obtaining informed consent
- Diagnosis of esophageal cancer
- Inability to read and speak English
- Presenting for a day surgery
- Presenting for foregut surgery (e.g. paraesophageal hernia repair)
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Current incarceration
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT04342260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.