Developing and validating utility parameters to establish patient-reported outcome-based perioperative symptom management in patients with lung cancer: a multicentre, prospective, observational cohort study protocol

BMJ Open. 2019 Oct 28;9(10):e030726. doi: 10.1136/bmjopen-2019-030726.

Abstract

Introduction: Patient-reported outcome-based symptom monitoring and alerting have been attractive for patient care after a tumour-removal surgery. However, the implementation parameters of this patient-centred symptom management system in perioperative patients with lung cancer are still lacking. We aim to develop a perioperative symptom scale (PSS) for monitoring, to determine the optimal time points for symptom assessment and to define the alert thresholds for medical intervention.

Methods and analysis: This study will prospectively recruit 300 patients undergoing lung cancer surgery in six hospitals. The MD Anderson Symptom Inventory-Lung Cancer Module (MDASI-LC) is used to collect longitudinal symptom data preoperatively, daily postoperatively during in-hospital stay and weekly after discharge until 4 weeks or the start of postoperative oncological therapy. Symptoms that change significantly over time will be generated as the PSS. We will determine the optimal time points for follow-up using the generalised linear mixed-effects models. The MDASI-LC interference-measured functional status will be used as the anchor for the alert thresholds.

Ethics and dissemination: Ethics Committee of Sichuan Cancer Hospital approved this study on 16 October 2017 (No. SCCHEC-02-2017-042). The manuscript is based on the latest protocol of Version 3.0, 15 September 2019. The results of this study will be presented at medical conferences and published in peer-reviewed journals.

Trials registration number: NCT03341377.

Keywords: lung cancer; patient-reported outcomes; perioperative symptom management; protocol; utility parameters.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Cohort Studies
  • Dyspnea / diagnosis
  • Dyspnea / physiopathology
  • Dyspnea / therapy
  • Fatigue / diagnosis
  • Fatigue / physiopathology
  • Fatigue / therapy
  • Humans
  • Lung Neoplasms / physiopathology
  • Lung Neoplasms / surgery*
  • Pain, Postoperative / diagnosis
  • Pain, Postoperative / physiopathology
  • Pain, Postoperative / therapy
  • Patient Reported Outcome Measures*
  • Perioperative Care / methods*
  • Postoperative Complications / diagnosis*
  • Postoperative Complications / physiopathology
  • Postoperative Complications / therapy
  • Prospective Studies
  • Reproducibility of Results
  • Symptom Assessment

Associated data

  • ClinicalTrials.gov/NCT03341377