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Downloaded from Developing and validating utility parameters to establish patient-reported outcome-based postoperative symptom management in patients with lung cancer: a multicentre, prospective, observational cohort study protocol ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2019-030726 Article Type: Protocol Date Submitted by the 28-Mar-2019 Author: Complete List of Authors: Dai, Wei; Sichuan Cancer Hospital and Research Institute, Department of Thoracic Surgery Xie, Shaohua; Chengdu Medical College, Graduate School Zhang, Rui ; The Seventh People's Hospital of Chengdu, Department of Thoracic Surgery Wei, Xing ; Sichuan Cancer Hospital and Research Institute, Department of Thoracic Surgery Wu, Chuanmei ; Sichuan Cancer Hospital and Research Institute, Department of Thoracic Surgery Zhang, Yuanqiang; Zigong First People's Hospital, Department of Cardiothoracic Surgery Feng, Wenhong ; Jiangyou People's Hospital, Department of Thoracic and http://bmjopen.bmj.com/ Cardiovascular Surgery Liao, Xiaoqing ; Dazhu County People's Hospital, Department of Cardiothoracic Surgical Oncology Mu, Yunfei ; The Third People's Hospital of Chengdu, Department of Thoracic Surgery Zhou, Heling ; Sichuan Cancer Hospital and Research Institute, Department of Thoracic Surgery Cheng, Xuemei ; Sichuan Cancer Hospital and Research Institute Jiang, Yanhua ; Sichuan Cancer Hospital and Research Institute, on September 26, 2021 by guest. Protected copyright. Department of Thoracic Surgery He, Jintao ; Sichuan Cancer Hospital and Research Institute, Department of Thoracic Surgery Li, Qiang; Sichuan Cancer Hospital and Research Institute, Department of Thoracic Surgery Yang, Xiaojun ; Sichuan Cancer Hospital and Research Institute, Department of Thoracic Surgery Shi, Qiuling; University of Texas MD Anderson Cancer Center, Department of Symptom Research utility parameters, lung cancer, patient-reported outcomes, Keywords: postoperative symptom management, protocol For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 15 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-030726 on 28 October 2019. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 26, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 15 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2019-030726 on 28 October 2019. Downloaded from 4 Title page 5 6 7 Title: Developing and validating utility parameters to establish patient-reported outcome- 8 9 10 based postoperative symptom management in patients with lung cancer: a multicentre, 11 12 prospective, observational cohort study protocol 13 14 15 Authors: Wei Dai1#, Shaohua Xie1,2#, Rui Zhang3#, Xing Wei1#, Chuanmei Wu1#, Yuanqiang 16 17 Zhang4, Wenhong Feng5, Xiaoqing Liao6, Yunfei Mu7, Heling Zhou1, Xuemei Cheng1, Yanhua 18 For peer review only 19 Jiang1, Jintao He1, Qiang Li1, Xiaojun Yang1, Qiuling Shi8 20 21 22 Institutions: 23 24 1 25 Department of Thoracic Surgery, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, 26 School of Medicine, University of Electronic Science and Technology of China, Chengdu, 27 28 Sichuan, China. 29 2 30 Graduate School, Chengdu Medical College, Chengdu, Sichuan, China. 31 3Department of Thoracic Surgery, The Seventh People's Hospital of Chengdu, Chengdu, 32 33 Sichuan, China. 34 4Department of Cardiothoracic Surgery, Zigong First People's Hospital, Zigong, Sichuan, 35 36 China. http://bmjopen.bmj.com/ 37 5 38 Department of Thoracic and Cardiovascular Surgery, Jiangyou People's Hospital, Jiangyou, 39 Sichuan, China. 40 6 41 Department of Cardiothoracic Surgical Oncology, Dazhu County People's Hospital, Dazhu 42 County, Dazhou, Sichuan, China. 43 44 7Department of Thoracic Surgery, The Third People's Hospital of Chengdu, Chengdu, Sichuan, 45 China. on September 26, 2021 by guest. Protected copyright. 46 47 8Department of Symptom Research, The University of Texas MD Anderson Cancer Center, 48 49 Houston, Texas, USA. 50 51 52 Correspondence to 53 Dr Qiuling Shi, Department of Symptom Research, The University of Texas MD Anderson 54 55 Cancer Center, 1515 Holcombe Blvd., Unit 1450 Houston, TX 77030, USA. Telephone: 56 713/745-3504, e-mail: [email protected]. 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 15 BMJ Open 1 2 3 Dr Xiaojun Yang, Department of Thoracic Surgery, Sichuan Cancer Hospital & Institute, BMJ Open: first published as 10.1136/bmjopen-2019-030726 on 28 October 2019. Downloaded from 4 5 Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology 6 of China, No. 55, Section 4, South Renmin Road, Chengdu 610041, Sichuan, China. Telephone: 7 8 +86-028-85420366, e-mail: [email protected]. 9 10 11 #These authors contributed equally to this work. 12 13 14 15 Word count 1737 words 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44 45 on September 26, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 15 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2019-030726 on 28 October 2019. Downloaded from 4 5 ABSTRACT 6 7 8 Introduction Patient-reported outcome (PRO)-based symptom monitoring and alerting have 9 10 been attractive for patient care after a tumour-removal surgery. However, the implementation 11 12 parameters of this patient-centred symptom management system in postoperative patients with 13 14 lung cancer are still lacking. We aim to develop a symptom index for monitoring, to determine 15 16 the optimal time points for symptom assessment, and to define alert thresholds for medical 17 intervention. 18 For peer review only 19 20 Methods and analysis The study will prospectively recruit 300 patients with lung cancer 21 22 undergoing surgery in 6 hospitals. The MD Anderson Symptom Inventory-lung cancer module 23 24 will be used to collect longitudinal symptom data within 3 days before surgery, daily 25 26 postoperatively during in-hospital stay, and weekly after discharge until 4 weeks or the start of 27 28 postoperative oncologic treatment. 29 30 31 Ethics and dissemination The study was approved by the Ethics Committee of Sichuan Cancer 32 33 Hospital on October 16, 2017 (No. SCCHEC-02-2017-042). This manuscript is based on the 34 Version 2.0, June 1, 2018 of the protocol. The results of this study will be presented at medical 35 36 conferences and published in peer-reviewed journals. 37 http://bmjopen.bmj.com/ 38 39 Trials registration number NCT03341377. 40 41 42 Keywords utility parameters, lung cancer, patient-reported outcomes, postoperative symptom 43 44 management, protocol. 45 on September 26, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 15 BMJ Open 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2019-030726 on 28 October 2019. Downloaded from 4 ARTICLE SUMMARY 5 6 Strengths and limitations of this study 7 8 9 1. This is a multicentre, prospective, observational cohort study from the real-world clinical 10 11 setting in China. 12 13 2. It focuses on developing and validating utility parameters for future implementation of 14 15 patient-reported outcome (PRO)-based postoperative symptom management in patients with 16 17 lung cancer. 18 For peer review only 19 20 3. It focuses on frequent postoperative longitudinal symptom data collection, including 21 22 preoperatively, daily postoperatively, and weekly after discharge until 4 weeks or the start of 23 24 postoperative oncologic treatment. 25 26 4. The MD Anderson Symptom Inventory-lung cancer module will be used to collect patient- 27 28 reported outcomes. 29 30 31 5. The fact that five sub-centres joined midway through the study may be a limitation. 32 33 34 35 36 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44 45 on September 26, 2021 by guest. Protected copyright.