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Completed

NCT Number: NCT04342260

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.

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Key information

Conditions

Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Quality of Life at 12 Months

    Time frame: 12 months post-discharge

    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.

  2. Lung Cancer Specific Quality of Life at 12 Months

    Time frame: 12 months post-discharge

    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

  3. PRO Symptom Monitoring Surveys Completed at 3 Months

    Time frame: 3 months post-discharge

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

  4. PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months

    Time frame: 3 months post-discharge

    The percentage of survey alerts that generate a clinician response will be calculated.

  5. Barriers and Facilitators of PRO Monitoring After Thoracic Surgery

    Time frame: assessed at 2 months through 2 years post-discharge

    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.

Secondary outcomes

  1. Readmission at 3 Months

    Time frame: 3 months post-discharge

    Readmission rates after thoracic surgery.

  2. Overall Survival at 12 Months

    Time frame: 12 months post-discharge

    Survival will be compared between arms using Cox proportional hazards regression model.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • American College of Surgeons
  • Thoracic Surgery Foundation

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2020
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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