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. 2019 Aug 26;9(8):e030041.
doi: 10.1136/bmjopen-2019-030041.

Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial

Wei Dai #  1 , Yuanqiang Zhang #  2 , Wenhong Feng  3 , Xiaoqing Liao  4 , Yunfei Mu  5 , Rui Zhang  6 , Xing Wei  1 , Chuanmei Wu  1 , Shaohua Xie  1   7 , Qiang Li  8 , Qiuling Shi  9
Affiliations

Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial

Wei Dai et al. BMJ Open. .

Abstract

Introduction: Surgery is one of the primary treatments for lung cancer. The postoperative symptom burden experienced by patients with lung cancer is substantial, seriously delaying their recovery from surgery and impairing their quality of life. Patient-reported outcome (PRO)-based symptom management is increasingly regarded as an optimal model for patient-centred care. Currently, clinical trial-based evidence involving early-phase (immediately after surgery for up to 1 month) symptom management of lung cancer is lacking. We propose a randomised trial to evaluate the effect of a PRO-based symptom-monitoring programme with overthreshold alerts and responses for postoperative recovery in patients with lung cancer.

Methods and analysis: The study will recruit 160 patients with lung cancer from six hospitals. The patients will be randomly allocated to the intervention group or control group in a ratio of 1:1. Patients in the intervention group will receive PRO-based symptom management from the specialists when their reported target symptom (pain, coughing, fatigue, disturbed sleep and shortness of breath) scores reach the preset threshold (score ≥4). Patients in the control group will not generate alerts and will follow the standard procedures for symptom management. All patients will receive symptom assessments via the MD Anderson Symptom Inventory-lung cancer module on the day before surgery, daily after surgery and twice a week after discharge until 4 weeks or the start of postoperative oncological treatment. The primary outcome-mean symptom threshold events-will be compared between the intervention and control group via independent sample Student's t-test.

Ethics and dissemination: The study was approved by the Ethics Committee of Sichuan Cancer Hospital on 22 November 2018 (No. SCCHEC-02-2018-045). This manuscript is based on V.2.0, 9 May 2019 of the protocol. The study results will be disseminated in publications in peer-reviewed journals and presentations at academic conferences.

Trials registration number: ChiCTR1900020846.

Keywords: lung cancer; patient-reported outcomes; postoperative symptom management; randomised controlled trial.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Schematic diagram of the SMARS. ePRO, electronic patient-reported outcome; REDCap, research electronic data capture; SMARS, symptom monitoring, alerting and response system.
Figure 2
Figure 2
Flow chart of this parallel group randomised trial. PRO, patient-reported outcome.
See this image and copyright information in PMC

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