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

NCT04342260 | Completed Results

• 1 other identifier: LCCC1945
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery

Keywords

Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  12 months post-discharge

• PRO Symptom Monitoring Surveys Completed at 3 Months

  The percentage of subjects who completed symptom surveys out of delivered symptom surveys.

  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.

  3 months post-discharge

• Barriers and Facilitators of PRO Monitoring After Thoracic Surgery

  Barriers and facilitators of PRO monitoring after thoracic surgery will be assessed using qualitative methods. A subset of patients and caregivers participated in semi-structured interviews. Thematic analysis was used to identify determinants.

  assessed at 2 months through 2 years post-discharge

Secondary Outcomes (2)

• Readmission at 3 Months

  3 months post-discharge

• Overall Survival at 12 Months

  12 months post-discharge

Study Arms (2)

Active Monitoring

EXPERIMENTAL

Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.

Other: Active Monitoring

Passive Monitoring

ACTIVE COMPARATOR

Clinicians will not receive any symptom alerts.

Other: Passive Monitoring

Interventions

Active Monitoring OTHER

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 Monitoring

Passive Monitoring OTHER

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.

Passive Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Thoracic Surgery Foundation: collaborator
• American College of Surgeons: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Amanda Gentry
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

agentry@email.unc.edu

(336) 655-7743

Study Officials

• Gita Mody, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 10, 2020
• Study Start: April 30, 2020
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: February 20, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)