NCT04342260

Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single center, randomized feasibility study. A total of 140 patients undergoing thoracic surgery will be prospectively enrolled and randomized in a 1:1 ratio to one of two arms. All participants will complete patient-reported outcome (PRO) symptom monitoring. The two arms are 1) active symptom monitoring and 2) passive symptom monitoring. The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported. Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician. All participants will be administered survey instruments to assess quality of life, satisfaction, and health history. In addition, a subset of up to 40 participants will be chosen at 2 months postoperatively to complete a semi-structured interview about their postoperative symptom reporting experience.

Conditions

• Thoracic Surgery

Interventions

Type	Name	Description
OTHER	Active Monitoring	The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported.
OTHER	Passive Monitoring	Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.

Timeline

• Start date: 2020-04-30
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2020-04-10
• Last updated: 2025-02-20
• Results posted: 2025-02-20

Locations

1 site across 1 country: United States