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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342260
• Other study ID #: LCCC1945
• Status: Completed
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: November 10, 2023

Study information

• Verified date: January 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	The Thoracic Surgery Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Readmission at 3 months	Readmission will be compared between arms using Cox proportional hazards regression model.	Baseline through 3 months post-discharge
Secondary	Overall Survival at 12 months	Survival will be compared between arms using Cox proportional hazards regression model.	Baseline through 12 months post-discharge
Secondary	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