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

UNC Lineberger Comprehensive Cancer Center logo

UNC Lineberger Comprehensive Cancer Center

Status

Completed

Conditions

Thoracic Surgery

Treatments

Other: Active Monitoring
Other: Passive Monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT04342260
LCCC1945

Details and patient eligibility

About

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.

Full 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.

Enrollment

113 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

113 participants in 2 patient groups

Active Monitoring
Experimental group
Description:
Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.
Treatment:
Other: Active Monitoring
Passive Monitoring
Active Comparator group
Description:
Clinicians will not receive any symptom alerts.
Treatment:
Other: Passive Monitoring

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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