Clinical trial NCT04342260: Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
Official title: Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Keywords: Patient-Reported Outcomes
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Thoracic Surgery Foundation
name: American College of Surgeons
First posted: 2020-04-10
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

Primary outcomes:
measure: Quality of Life at 12 Months
timeFrame: 12 months post-discharge
measure: Lung Cancer Specific Quality of Life at 12 Months
timeFrame: 12 months post-discharge
measure: PRO Symptom Monitoring Surveys Completed at 3 Months
timeFrame: 3 months post-discharge
measure: PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months
timeFrame: 3 months post-discharge
measure: Barriers and Facilitators of PRO Monitoring After Thoracic Surgery
timeFrame: assessed at 2 months through 2 years post-discharge
Secondary outcomes:
measure: Readmission at 3 Months
timeFrame: 3 months post-discharge
measure: Overall Survival at 12 Months
timeFrame: 12 months post-discharge
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gita Mody, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: