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

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.

journal_name

BMJ Open

journal_title

BMJ open

authors

Dai W,Zhang Y,Feng W,Liao X,Mu Y,Zhang R,Wei X,Wu C,Xie S,Li Q,Shi Q

doi

10.1136/bmjopen-2019-030041

subject

Has Abstract

pub_date

2019-08-26 00:00:00

pages

e030041

issue

issn

2044-6055

pii

bmjopen-2019-030041

journal_volume

pub_type

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