Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial

Wei Dai, Wenhong Feng, Yuanqiang Zhang, Xin Shelley Wang, Yangjun Liu, Cecilia Pompili, Wei Xu, Shaohua Xie, Yaqin Wang, Jia Liao, Xing Wei, Run Xiang, Bin Hu, Bo Tian, Xiaozun Yang, Xiang Wang, Ping Xiao, Qi Lai, Xin Wang, Bangrong Cao, Qifeng Wang, Fang Liu, Xiaoqin Liu, Tianpeng Xie, Xiaojun Yang, Xiang Zhuang, Zhong Wu, Guowei Che, Qiang Li, Qiuling Shi, Wei Dai, Wenhong Feng, Yuanqiang Zhang, Xin Shelley Wang, Yangjun Liu, Cecilia Pompili, Wei Xu, Shaohua Xie, Yaqin Wang, Jia Liao, Xing Wei, Run Xiang, Bin Hu, Bo Tian, Xiaozun Yang, Xiang Wang, Ping Xiao, Qi Lai, Xin Wang, Bangrong Cao, Qifeng Wang, Fang Liu, Xiaoqin Liu, Tianpeng Xie, Xiaojun Yang, Xiang Zhuang, Zhong Wu, Guowei Che, Qiang Li, Qiuling Shi

Abstract

Purpose: We aimed to evaluate the efficacy and feasibility of patient-reported outcome (PRO)-based symptom management in the early period after lung cancer surgery.

Methods: Before surgery, patients with clinically diagnosed lung cancer were randomly assigned 1:1 to receive postoperative PRO-based symptom management or usual care. All patients reported symptoms on MD Anderson Symptom Inventory-Lung Cancer presurgery, daily postsurgery, and twice a week after discharge for up to 4 weeks via an electronic PRO system. In the intervention group, treating surgeons responded to overthreshold electronic alerts driven by any of the five target symptom scores (score ≥ 4 on a 0-10 scale for pain, fatigue, disturbed sleep, shortness of breath, and coughing). The control group patients received usual care and no alerts were generated. The primary outcome was the number of symptom threshold events (any target symptom with a score of ≥ 4) at discharge. Per-protocol analyses were conducted.

Results: Of the 166 participants, 83 were randomly allocated to each group. At discharge, the intervention group reported fewer symptom threshold events than the control group (median [interquartile range], 0 [0-2] v 2 [0-3]; P = .007). At 4 weeks postdischarge, this difference was maintained between the intervention and control groups (median [interquartile range], 0 [0-0] v 0 [0-1]; P = .018). The intervention group had a lower complication rate than the control group (21.5% v 40.6%; P = .019). Surgeons spent a median of 3 minutes managing an alert.

Conclusion: PRO-based symptom management after lung cancer surgery showed lower symptom burden and fewer complications than usual care for up to 4 weeks postdischarge.

Conflict of interest statement

Xin Shelley WangPatents, Royalties, Other Intellectual Property: Symptom Assessment Systems, LLC Cecilia PompiliConsulting or Advisory Role: AstraZenecaSpeakers' Bureau: BD Medical, MedelaNo other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
CONSORT diagram.
FIG 2.
FIG 2.
Number of symptom threshold events at discharge in all hospitals, the cancer hospital, and the general hospital. The box plot shows the median (horizontal line in the box), 25th and 75th quartiles (box limits), and minimum and maximum (bars). PRO, patient-reported outcome; IQR, interquartile range. PRO-based symptom management may be the preferred patient care approach following lung cancer surgery.
FIG 3.
FIG 3.
Symptom severity over time. (A) Composite symptom score of the target symptoms (pain, fatigue, disturbed sleep, shortness of breath, and coughing) during hospitalization. (B) Composite symptom score of the target symptoms after discharge. High scores indicate more severe symptoms. I bars represent 95% CIs. PRO, patient-reported outcome.
FIG 4.
FIG 4.
Functional interference over time. (A) Composite physical interference score (MDASI-LC general activity, work, and walking) during hospitalization. (B) Composite physical interference score after discharge. (C) Composite affective interference score (MDASI-LC mood, relations with others, and enjoyment of life) during hospitalization. (D) Composite affective interference score after discharge. High scores indicate more severe functional interference. I bars represent 95% CIs. MDASI-LC, MD Anderson Symptom Inventory-Lung Cancer module; PRO, patient-reported outcome.

References

    1. Sung H, Ferlay J, Siegel RL, et al. : Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 71:209-249, 2021
    1. Zhou Q, Fan Y, Wang Y, et al. : China national lung cancer screening guideline with low-dose computed tomography (2018 version) [in Chinese]. Zhongguo Fei Ai Za Zhi 21:67-75, 2018
    1. Fagundes CP, Shi Q, Vaporciyan AA, et al. : Symptom recovery after thoracic surgery: Measuring patient-reported outcomes with the MD Anderson Symptom Inventory. J Thorac Cardiovasc Surg 150:613-619.e612, 2015
    1. Lin S, Chen Y, Yang L, et al. : Pain, fatigue, disturbed sleep and distress comprised a symptom cluster that related to quality of life and functional status of lung cancer surgery patients. J Clin Nurs 22:1281-1290, 2013
    1. Di Maio M, Gallo C, Leighl NB, et al. : Symptomatic toxicities experienced during anticancer treatment: Agreement between patient and physician reporting in three randomized trials. J Clin Oncol 33:910-915, 2015
    1. Basch E, Deal AM, Kris MG, et al. : Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. J Clin Oncol 34:557-565, 2016
    1. Girgis A, Durcinoska I, Arnold A, et al. : Web-based patient-reported outcome measures for personalized treatment and care (PROMPT-Care): Multicenter pragmatic nonrandomized trial. J Med Internet Res 22:e19685, 2020
    1. Basch E: Patient-reported outcomes - Harnessing patients' voices to improve clinical care. N Engl J Med 376:105-108, 2017
    1. Sun V, Kim J: Symptom and functional recovery monitoring in thoracic surgery. J Thorac Dis 12:6931-6939, 2020
    1. Nipp RD, El-Jawahri A, Ruddy M, et al. : Pilot randomized trial of an electronic symptom monitoring intervention for hospitalized patients with cancer. Ann Oncol 30:274-280, 2019
    1. Cleeland CS, Wang XS, Shi Q, et al. : Automated symptom alerts reduce postoperative symptom severity after cancer surgery: A randomized controlled clinical trial. J Clin Oncol 29:994-1000, 2011
    1. Absolom K, Warrington L, Hudson E, et al. : Phase III randomized controlled trial of eRAPID: eHealth intervention during chemotherapy. J Clin Oncol 39:734-747, 2021
    1. Basch E, Deal AM, Dueck AC, et al. : Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 318:197-198, 2017
    1. Barbera L, Sutradhar R, Seow H, et al. : The impact of routine Edmonton Symptom Assessment System (ESAS) use on overall survival in cancer patients: Results of a population-based retrospective matched cohort analysis. Cancer Med 9:7107-7115, 2020
    1. Graetz I, Anderson JN, McKillop CN, et al. : Use of a web-based app to improve postoperative outcomes for patients receiving gynecological oncology care: A randomized controlled feasibility trial. Gynecol Oncol 150:311-317, 2018
    1. Dai W, Zhang Y, Feng W, et al. : Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: Protocol for a multicentre, randomised controlled trial. BMJ Open 9:e030041, 2019
    1. Goldstraw P, Chansky K, Crowley J, et al. : The IASLC Lung Cancer Staging Project: Proposals for revision of the TNM stage groupings in the forthcoming (eighth) edition of the TNM Classification for lung cancer. J Thorac Oncol 11:39-51, 2016
    1. Wei X, Yu H, Dai W, et al. : Patient-reported outcomes of video-assisted thoracoscopic surgery versus thoracotomy for locally advanced lung cancer: A longitudinal cohort study. Ann Surg Oncol 28:8358-8371, 2021
    1. Harris PA, Taylor R, Thielke R, et al. : Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377-381, 2009
    1. Montag C, Becker B, Gan C: The multipurpose application WeChat: A review on recent research. Front Psychol 9:2247, 2018
    1. Mendoza TR, Wang XS, Lu C, et al. : Measuring the symptom burden of lung cancer: The validity and utility of the lung cancer module of the M. D. Anderson Symptom Inventory. Oncologist 16:217-227, 2011
    1. Sloan JA, Loprinzi CL, Kuross SA, et al. : Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. J Clin Oncol 16:3662-3673, 1998
    1. Swarm RA, Paice JA, Anghelescu DL, et al. : Adult cancer pain, version 3.2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 17:977-1007, 2019
    1. Bower JE, Bak K, Berger A, et al. : Screening, assessment, and management of fatigue in adult survivors of cancer: An American Society of Clinical Oncology clinical practice guideline adaptation. J Clin Oncol 32:1840-1850, 2014
    1. Molassiotis A, Smith JA, Bennett MI, et al. : Clinical expert guidelines for the management of cough in lung cancer: Report of a UK task group on cough. Cough 6:9, 2010
    1. Denlinger CS, Ligibel JA, Are M, et al. : Survivorship: Sleep disorders, version 1.2014. J Natl Compr Canc Netw 12:630-642, 2014
    1. Parshall MB, Schwartzstein RM, Adams L, et al. : An official American Thoracic Society statement: Update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med 185:435-452, 2012
    1. Dindo D, Demartines N, Clavien PA: Classification of surgical complications: A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205-213, 2004
    1. Cleeland CS, Mendoza TR, Wang XS, et al. : Levels of symptom burden during chemotherapy for advanced lung cancer: Differences between public hospitals and a tertiary cancer center. J Clin Oncol 29:2859-2865, 2011
    1. Basch E, Mody GN, Dueck AC: Electronic patient-reported outcomes as digital therapeutics to improve cancer outcomes. JCO Oncol Pract 16:541-542, 2020
    1. Smith AB, Schwarze ML: Translating patient-reported outcomes from surgical research to clinical care. JAMA Surg 152:811-812, 2017
    1. Philpot LM, Barnes SA, Brown RM, et al. : Barriers and benefits to the use of patient-reported outcome measures in routine clinical care: A qualitative study. Am J Med Qual 33:359-364, 2018
    1. Rotenstein LS, Huckman RS, Wagle NW: Making patients and doctors happier—The potential of patient-reported outcomes. N Engl J Med 377:1309-1312, 2017
    1. Mooney KH, Beck SL, Friedman RH, et al. : Automated monitoring of symptoms during ambulatory chemotherapy and oncology providers' use of the information: A randomized controlled clinical trial. Support Care Cancer 22:2343-2350, 2014
    1. van der Hout A, van Uden-Kraan CF, Holtmaat K, et al. : Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: A randomised, controlled trial. Lancet Oncol 21:80-94, 2020
    1. Nguyen H, Butow P, Dhillon H, et al. : A review of the barriers to using Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs) in routine cancer care. J Med Radiat Sci 68:186-195, 2021
    1. Nüesch E, Trelle S, Reichenbach S, et al. : The effects of excluding patients from the analysis in randomised controlled trials: Meta-epidemiological study. BMJ 339:b3244, 2009

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