"Longitudinal patient-reported outcomes 1 year after thoracoscopic segmentectomy versus lobectomy for early-stage lung cancer: a multicentre, prospective cohort study protocol"

作者全名："Gao, Xin; Dai, Wei; Zhang, Qi; Liu, Wenwu; Liu, Yangjun; Yang, Lingjia; Wei, Xing; Shi, Qiuling; Pompili, Cecilia; Pu, Yang; Xie, Shaohua; Xiang, Run; Tian, Bo; Hu, Bin; Yang, Xiaozun; Wang, Xiang; Yang, Xiaojun; Xie, Tianpeng; Tang, Yong; Qiao, Guibin; Sun, Nan; Gao, Shan; Zhang, Guangjian; Chen, Dan; Cui, Yue; Chen, Xiaobo; He, Yu; Zhang, Rong; Li, Qiang; Zhuang, Xiang"

作者地址："[Gao, Xin; Dai, Wei; Zhang, Qi; Liu, Wenwu; Wei, Xing; Xie, Shaohua; Xiang, Run; Tian, Bo; Hu, Bin; Yang, Xiaozun; Wang, Xiang; Yang, Xiaojun; Xie, Tianpeng; Li, Qiang; Zhuang, Xiang] Univ Elect Sci & Technol China, Sichuan Canc Hosp & Inst, Sichuan Canc Ctr, Dept Thorac Surg, Chengdu, Sichuan, Peoples R China; [Zhang, Qi] Chengdu Med Coll, Grad Sch, Chengdu, Sichuan, Peoples R China; [Liu, Yangjun] Karolinska Inst, Dept Med Epidemiol & Biostat, Stockholm, Sweden; [Yang, Lingjia] Univ Birmingham, Coll Med & Dent Sci, Birmingham, W Midlands, England; [Shi, Qiuling] Univ Elect Sci & Technol China, Sichuan Canc Hosp & Inst, Ctr Canc Prevent Res, Sichuan Canc Ctr, Chengdu, Sichuan, Peoples R China; [Shi, Qiuling; Pu, Yang] Chongqing Med Univ, Sch Publ Hlth, Chongqing, Peoples R China; [Pompili, Cecilia] Univ & Hosp Trust Osped Borgo Trento, Thorac Surg Unit, Verona, Italy; [Pompili, Cecilia] Univ Leeds, Sect Patient Ctr Outcomes Res, Leeds Inst Med Res St Jamess, Leeds, W Yorkshire, England; [Tang, Yong; Qiao, Guibin] Guangdong Prov Peoples Hosp, Dept Thorac Surg, Guangzhou, Guangdong, Peoples R China; [Sun, Nan] Liaoning Canc Hosp & Inst, Dept Thorac Surg, Shenyang, Liaoning, Peoples R China; [Gao, Shan; Zhang, Guangjian] Xi An Jiao Tong Univ, Dept Thorac Surg, Affiliated Hosp 1, Xian, Shaanxi, Peoples R China; [Chen, Dan] Chongqing Med Univ, Dept Thorac Surg, Affiliated Hosp 1, Chongqing, Peoples R China; [Cui, Yue; Chen, Xiaobo] Kunming Med Univ, Dept Thorac Surg, Affiliated Hosp 1, Kunming, Yunnan, Peoples R China; [He, Yu; Zhang, Rong] Yaan Peoples Hosp, Dept Thorac Surg, Yaan, Sichuan, Peoples R China"

通信作者："Zhuang, X (通讯作者)，Univ Elect Sci & Technol China, Sichuan Canc Hosp & Inst, Sichuan Canc Ctr, Dept Thorac Surg, Chengdu, Sichuan, Peoples R China."

来源：BMJ OPEN

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000924570800027

JCR分区：Q1

影响因子：2.4

年份：2023

卷号：13

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：Thoracic surgery; ONCOLOGY; Cancer pain

摘要："IntroductionSegmentectomy and lobectomy are the main surgical procedures for early-stage lung cancer. However, few studies have analysed patient-reported outcomes after segmentectomy versus lobectomy. This study aims to compare patient-reported outcomes-such as symptoms, daily functioning and quality of life-between thoracoscopic segmentectomy and lobectomy for early-stage lung cancer during the 1year after surgery.Methods and analysisOverall, 788 newly diagnosed patients with early-stage lung cancer (tumour size <= 2cm), who are scheduled to undergo thoracoscopic segmentectomy or lobectomy, will be recruited in this multicentre, prospective cohort study. The patients will receive standardised care after surgery. The Perioperative Symptom Assessment for Lung Surgery-a validated lung cancer surgery-specific scale-will be used to assess the symptoms and functions at baseline, at discharge and monthly after discharge for 1year. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Lung Cancer module 29 will be used to assess the patients' quality of life at the same time points. The primary outcome will be the shortness of breath scores during the first year after thoracoscopic segmentectomy and lobectomy and will be compared using mixed-effects models. The secondary outcomes will include other symptoms, indicators of daily functioning, quality of life scores and traditional clinical outcomes. These will be compared using mixed-effects models and the Student's t-test, non-parametric test or Chi(2) test. Propensity score matching will be used to ensure an even distribution of known confounders between the groups.Ethics and disseminationThe Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital approved this study (approval number: SCCHEC-02-2022-002). All participants will be instructed to provide informed consent. The manuscript is based on protocol version 3.0. The study results will be presented at medical conferences and published in peer-reviewed journals.Trial registration numberChiCTR2200060753."

基金机构：Bethune Charitable Foundation [CESS2021TC01]; Sichuan Science and Technology Program [2019YFG0517]; Clinical Key Specialty Construction Project Funding of Sichuan Province

基金资助正文："This work is supported by the Bethune Charitable Foundation (grant number CESS2021TC01), Sichuan Science and Technology Program (grant number 2019YFG0517) and Clinical Key Specialty Construction Project Funding of Sichuan Province."