Quality of life between home-based and outpatient pulmonary rehabilitation in patients after surgical resection for lung cancer: protocol for a prospective, single-blind, randomised controlled trial

Introduction Lung cancer remains a highly fatal disease. Surgical resection has been proven to be the most effective treatment for early-stage lung cancer. The conventional hospital-based pulmonary rehabilitation (PR) is shown to reduce symptoms, improve exercise capacity and impact the quality of life (QoL) for lung cancer patients. To date, scientific evidence on the effectiveness of home-based PR for patients with lung cancer following surgery is scarce. We aim to explore if home-based PR is non-inferior to outpatient PR for patients with lung cancer following surgical resection. Methods and analysis This study is a two-arm, parallel-group, assessor-blind, single-centre, randomised controlled trial. Participants will be recruited from West China Hospital, Sichuan University and randomly allocated to either an outpatient group or a home-based group at a ratio of 1:1. The PR programme involves self-management and exercises. The exercise includes warm-up (10 min), aerobic training (20 min), resistance training (15 min) and cool-down (10 min), lasting 4 weeks, with two sessions per week either at home or in the outpatient setting. The intensity will be adjusted according to the modified Borg rating of perceived exertion and heart rate before and after each exercise session. The primary outcome is QoL measured by EORTC QLQ-C30 & LC 13 after an intervention. Secondary outcomes include physical fitness measured by a 6 min walk test and stair-climbing test and symptom severity measured by patient-reported questionnaires and pulmonary function. The main hypothesis is that home-based PR is non-inferior to outpatient PR for patients with lung cancer following surgical resection. Ethics and dissemination The trial has been approved by the Ethical Committee of West China Hospital and is also registered with the Chinese Clinical Trial Registry. The results of this study will be disseminated through peer-reviewed publications and presentations at national and international conferences. Trial registration number ChiCTR2100053714.

[1]  C. Malaguti,et al.  Supervised maintenance programmes following pulmonary rehabilitation compared to usual care for chronic obstructive pulmonary disease. , 2021, The Cochrane database of systematic reviews.

[2]  L. Sequist,et al.  Lung cancer , 2021, The Lancet.

[3]  A. Jemal,et al.  Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries , 2021, CA: a cancer journal for clinicians.

[4]  Hung-I Lu,et al.  A six-week inspiratory muscle training and aerobic exercise improves respiratory muscle strength and exercise capacity in lung cancer patients after video-assisted thoracoscopic surgery: A randomized controlled trial , 2020, Clinical rehabilitation.

[5]  Brady J. McKee,et al.  Lung Screening Benefits and Challenges: A Review of The Data and Outline for Implementation. , 2020, Journal of Thoracic Oncology.

[6]  N. Beyer,et al.  12-months follow-up of pulmonary tele-rehabilitation versus standard pulmonary rehabilitation: A multicentre randomised clinical trial in patients with severe COPD. , 2020, Respiratory medicine.

[7]  E. Feuer,et al.  The Effect of Advances in Lung-Cancer Treatment on Population Mortality. , 2020, The New England journal of medicine.

[8]  A. Cuvelier,et al.  Performance at stair-climbing test is associated with postoperative complications after lung resection: a systematic review and meta-analysis , 2020, Thorax.

[9]  S. Vinod,et al.  Radiotherapy treatment for lung cancer: Current status and future directions , 2020, Respirology.

[10]  N. Beyer,et al.  Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial , 2020, Thorax.

[11]  Harry J de Koning,et al.  Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. , 2020, The New England journal of medicine.

[12]  Moon Soo Kim,et al.  The association of physical function and quality of life on physical activity for non-small cell lung cancer survivors , 2020, Supportive Care in Cancer.

[13]  Kevin McCarthy,et al.  Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement , 2019, American journal of respiratory and critical care medicine.

[14]  C. Granger,et al.  Practical approach to establishing pulmonary rehabilitation for people with non‐COPD diagnoses , 2019, Respirology.

[15]  F. Griesinger,et al.  Efficacy and safety of first-line carboplatin-versus cisplatin-based chemotherapy for non-small cell lung cancer: A meta-analysis. , 2019, Lung cancer.

[16]  M. Spruit,et al.  The usefulness of preoperative exercise therapy in patients scheduled for lung cancer surgery; a survey among Dutch pulmonologists and cardiothoracic surgeons , 2019, Supportive Care in Cancer.

[17]  S. Jones,et al.  Home versus outpatient pulmonary rehabilitation in COPD: a propensity-matched cohort study , 2019, Thorax.

[18]  C. V. van Eijck,et al.  Video-assisted thoracic lobectomy versus stereotactic body radiotherapy for stage I nonsmall cell lung cancer in elderly patients: a propensity matched comparative analysis , 2019, European Respiratory Journal.

[19]  Natalie S. Lui,et al.  A National Analysis of Short-term Outcomes and Long-term Survival Following Thoracoscopic Versus Open Lobectomy for Clinical Stage II Non-Small-Cell Lung Cancer , 2019, Annals of surgery.

[20]  E. Felip,et al.  Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). , 2017, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[21]  Sally J. Singh,et al.  Comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: a randomised non-inferiority trial , 2017, Thorax.

[22]  G. Che,et al.  [Simplification and Validation of Leicester Cough Questionnaire in Mandarin-Chinese]. , 2017, Zhongguo fei ai za zhi = Chinese journal of lung cancer.

[23]  W. Deng,et al.  The development and validation of Huaxi emotional-distress index (HEI): A Chinese questionnaire for screening depression and anxiety in non-psychiatric clinical settings. , 2017, Comprehensive psychiatry.

[24]  K. Kostikas,et al.  Home-based maintenance tele-rehabilitation reduces the risk for acute exacerbations of COPD, hospitalisations and emergency department visits , 2017, European Respiratory Journal.

[25]  J. Kozaka,et al.  Quality of life of lung cancer patients , 2016 .

[26]  Sally J. Singh,et al.  An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. , 2015, American journal of respiratory and critical care medicine.

[27]  P. Nana-Sinkam,et al.  Integrating pulmonary rehabilitation into the multidisciplinary management of lung cancer: a review. , 2015, Respiratory medicine.

[28]  Thierry Troosters,et al.  An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease , 2014, European Respiratory Journal.

[29]  S. Anderssen,et al.  High-intensity training following lung cancer surgery: a randomised controlled trial , 2014, Thorax.

[30]  Hong Zhu,et al.  Validation of EORTC QLQ-LC43 for Chinese patients with lung cancer. , 2014, Lung cancer.

[31]  N. Hopkinson,et al.  Effect of postoperative physical training on activity after curative surgery for non-small cell lung cancer: a multicentre randomised controlled trial. , 2014, Physiotherapy.

[32]  A. Marshall,et al.  Pulmonary rehabilitation programme for patients undergoing curative lung cancer surgery. , 2013, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[33]  Suzanne G. Leveille,et al.  Health-related quality of life after surgical treatment in patients with non-small cell lung cancer: a systematic review. , 2013, Lung cancer.

[34]  A. Chang,et al.  Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. , 2013, Chest.

[35]  D. Rennie,et al.  SPIRIT 2013 statement: defining standard protocol items for clinical trials. , 2013, Annals of internal medicine.

[36]  E. Mohammadi,et al.  Barriers and facilitators related to the implementation of a physiological track and trigger system: A systematic review of the qualitative evidence , 2017, International journal for quality in health care : journal of the International Society for Quality in Health Care.

[37]  D. Osoba,et al.  Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials , 2011, Supportive Care in Cancer.

[38]  D. Lee,et al.  Effects of pain, fatigue, insomnia, and mood disturbance on functional status and quality of life of elderly patients with cancer. , 2011, Critical reviews in oncology/hematology.

[39]  A. Holland,et al.  What prevents people with chronic obstructive pulmonary disease from attending pulmonary rehabilitation? A systematic review , 2011, Chronic respiratory disease.

[40]  C. Pompili,et al.  Predictors of postoperative decline in quality of life after major lung resections. , 2011, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[41]  C. Pompili,et al.  Low-technology exercise test in the preoperative evaluation of lung resection candidates. , 2010, Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace.

[42]  E. Coups,et al.  Fatigue and functional impairment in early-stage non-small cell lung cancer survivors. , 2010, Journal of pain and symptom management.

[43]  D. Moher,et al.  CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials , 2010, BMJ : British Medical Journal.

[44]  D. Moher,et al.  CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials , 2010, BMJ : British Medical Journal.

[45]  N. Altorki,et al.  Thoracoscopic lobectomy is associated with lower morbidity than open lobectomy: a propensity-matched analysis from the STS database. , 2010, The Journal of thoracic and cardiovascular surgery.

[46]  J. Mackey,et al.  Exercise intolerance in cancer and the role of exercise therapy to reverse dysfunction. , 2009, The Lancet. Oncology.

[47]  M. Yamashita,et al.  Very long-term outcomes of video-assisted thoracoscopic surgery for lung cancer , 2008, Surgical Endoscopy.

[48]  F. Schmidt Meta-Analysis , 2008 .

[49]  Thierry Troosters,et al.  American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. , 2006, American journal of respiratory and critical care medicine.

[50]  S. Pocock,et al.  Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. , 2006, JAMA.

[51]  S Ziebland,et al.  Stigma, shame, and blame experienced by patients with lung cancer: qualitative study , 2004, BMJ : British Medical Journal.

[52]  W. Chie,et al.  Quality of life of lung cancer patients: Validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13 , 2004, Quality of Life Research.

[53]  Sally J. Singh,et al.  Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ) , 2003, Thorax.

[54]  E. Smets,et al.  The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. , 1995, Journal of psychosomatic research.

[55]  D. Osoba,et al.  The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. , 1993, Journal of the National Cancer Institute.

[56]  S. Scalvini,et al.  Home-based telerehabilitation in older patients with chronic obstructive pulmonary disease and heart failure: a randomised controlled trial , 2018, Age and ageing.

[57]  V. Rusch,et al.  Patterns of recurrence and incidence of second primary tumors after lobectomy by means of video-assisted thoracoscopic surgery (VATS) versus thoracotomy for lung cancer. , 2011, The Journal of thoracic and cardiovascular surgery.

[58]  S. Kaasa,et al.  The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. , 1994, European journal of cancer.

[59]  G. Borg Psychophysical bases of perceived exertion. , 1982, Medicine and science in sports and exercise.

[60]  Sung Gyoo Park Medicine and Science in Sports and Exercise , 1981 .