TY - JOUR
T1 - Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer
T2 - Protocol for a multicentre, randomised controlled trial
AU - Dai, Wei
AU - Zhang, Yuanqiang
AU - Feng, Wenhong
AU - Liao, Xiaoqing
AU - Mu, Yunfei
AU - Zhang, Rui
AU - Wei, Xing
AU - Wu, Chuanmei
AU - Xie, Shaohua
AU - Li, Qiang
AU - Shi, Qiuling
N1 - Publisher Copyright:
© 2019 BMJ Publishing Group. All rights reserved.
PY - 2019/8/1
Y1 - 2019/8/1
N2 - 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.
AB - 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.
KW - lung cancer
KW - patient-reported outcomes
KW - postoperative symptom management
KW - randomised controlled trial
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U2 - 10.1136/bmjopen-2019-030041
DO - 10.1136/bmjopen-2019-030041
M3 - Article
C2 - 31455710
AN - SCOPUS:85071651406
SN - 2044-6055
VL - 9
JO - BMJ open
JF - BMJ open
IS - 8
M1 - e030041
ER -