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

Wei Dai, Shaohua Xie, Rui Zhang, Xing Wei, Chuanmei Wu, Yuanqiang Zhang, Wenhong Feng, Xiaoqing Liao, Yunfei Mu, Heling Zhou, Xuemei Cheng, Yanhua Jiang, Jintao He, Qiang Li, Xiaojun Yang, Qiuling Shi, Wei Dai, Shaohua Xie, Rui Zhang, Xing Wei, Chuanmei Wu, Yuanqiang Zhang, Wenhong Feng, Xiaoqing Liao, Yunfei Mu, Heling Zhou, Xuemei Cheng, Yanhua Jiang, Jintao He, Qiang Li, Xiaojun Yang, Qiuling Shi

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.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow diagram of this study.

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