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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery
• Intervention / Treatment: Other: Active Monitoring; Other: Passive Monitoring

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 40 participants and their caregivers will be chosen at 2 months postoperatively to complete a semi-structured interview about their postoperative symptom reporting experience.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients -

• 18 years or older
• English speaking
• Able and willing to complete web-based symptom survey
• Be presenting for inpatient thoracic surgery

Caregivers -

• 18 years or older
• English speaking
• Be a caregiver for a patient who has undergone thoracic surgery and enrolled in the PRO portion of the study

Exclusion Criteria:

Patients -

• 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

Caregiver -

• Inability to read and speak English
• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
• Current incarceration
• Not currently providing care for a patient who has undergone thoracic surgery and enrolled in the PRO portion of the study
• Receiving extensive medical treatment (e.g., caregivers admitted in the intensive care unit)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Monitoring; Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.	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.
Active Comparator: Passive Monitoring; Clinicians will not receive any symptom alerts.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life at 12 months	Quality of Life (QOL) will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) version 3.0 and reported as a score on a scale from 0 to 100 with a higher score being a better QOL.	Baseline through 12 months post-discharge
Lung cancer specific quality of life at 12 months	Lung cancer specific Quality of Life will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) supplement and reported as a score from 0 to 100 with a higher score being worse symptoms	Baseline through 12 months post-discharge
PRO symptom monitoring surveys completed at 3 months	The percentage of complete symptom surveys out of delivered symptom surveys will be calculated.	Baseline through 3 months post-discharge
PRO symptom monitoring alerts resulting in a clinician response at 3 months	The percentage of survey alerts that generate a clinician response will be calculated.	Baseline through 3 months post-discharge
Barriers and facilitators of PRO monitoring after thoracic surgery	Semi-structured interviews of patients and caregivers will be analyzed for themes.	2 months through 2 years post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission at 3 months	Readmission will be compared between arms using Cox proportional hazards regression model.	Baseline through 3 months post-discharge
Overall Survival at 12 months	Survival will be compared between arms using Cox proportional hazards regression model.	Baseline through 12 months post-discharge
Quality of life surveys completed at 2 years	The percentage of complete quality of life surveys out of delivered quality of life surveys will be calculated. The quality of life surveys consist of the EORTC QLQ-C30 and EORTC QLQ-LC13.	Baseline through 2 years post-discharge

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: The Thoracic Surgery Foundation
• Investigators: Principal Investigator: Gita Mody, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Actual): November 10, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Patient-Reported Outcomes
• Other Study ID Numbers: LCCC1945

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans as of now to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No