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The goal of this prospective, observational study is to measure and analyze the effect of adjuvant treatment over the quality of life and recovery of patients undergoing pulmonary resection because of non-small cells lung cancer using the EORTC-LC29 questionnaire. The main question it aims to answer is:
Whether adjuvant systemic treatment affect or not the postoperative QOL of a NSCLC patient that underwent lung resection
Participants will fulfill two questionnaires (EORTC-LC29 and Hospital Anxiety and Depression Scale) in different stages of their treatment.
Despite being surgery the preferred radical treatment of NSCLC in early stages, unforseen N2 disease, larger tumors or bad prognosis histological or molecular findings of the tumor will benefit of receiving adjuvant treatment.
As an adjuvant treatment, postoperative platinum-based chemotherapy has demonstrated its efficacy in increasing survival rates and reducing recurrence rates. Postoperative radiotherapy (RT) is limited due to decreased lung tolerance following surgery and conflicting results.
It is clear that lung cancer significantly impacts the quality of life of patients. According to the Lung Cancer Europe (LuCE) association, a survey conducted in 2021 with 515 patients revealed that 91.2% experienced limitations in their daily lives. Fatigue, sleep problems, cognitive difficulties, and significant reductions in physical activity were the main areas where patients reported the most complications. In addition to the inherent complications of cancer, we must consider the complications associated with surgery and systemic treatment.
Module LC29 is an update of the previous module published by the European Organisation for Research and Treatment of Cancer (EORTC), providing a more current perspective on lung cancer. This latest module retains 12 out of the 13 items from LC13 and adds 17 new items, which gather information on the side effects of medical and targeted therapies, as well as emotional problems. Furthermore, it includes 5 specific questions related to lung surgery. This multidisciplinary approach currently makes the LC29 questionnaire the most comprehensive tool for studying the quality of life of lung cancer patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | The patients will fulfill the EORTC-LC29 and HADS questionnaires in 5 different moments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life before and after adjuvant treatment in patients undergoing pulmonary resection | For quality of life assessment, patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). | Pre-surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the type of surgical procedure performed and postoperative quality of life | Measure and analyze the correlation between the type of surgical procedure performed and postoperative quality of life upon completion of the surgical episode and before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). The type of surgical procedure (segmentectomy, lobectomy or pneumonectomy), will be collected from the post-surgery report. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be formed by patients undergoing pulmonary resection because of lung cancer that are candidates of taking adjuvant treatment after surgery. The patients will be collected from the Thoracic Surgery Department of Hospital Clínico Universitario de Salamanca
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pablo Fernández Salvador, Nurse | Contact | +34 689147857 | pfs45@usal.es |
| Name | Affiliation | Role |
|---|---|---|
| Pablo Fernández Salvador, Nurse | University of Salamanca | Principal Investigator |
| Nuria M Novoa Valentín, MD, PhD | University of Salamanca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario | Salamanca | 37007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36633525 | Background | Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. | |
| 34808341 | Background | Nicholson AG, Tsao MS, Beasley MB, Borczuk AC, Brambilla E, Cooper WA, Dacic S, Jain D, Kerr KM, Lantuejoul S, Noguchi M, Papotti M, Rekhtman N, Scagliotti G, van Schil P, Sholl L, Yatabe Y, Yoshida A, Travis WD. The 2021 WHO Classification of Lung Tumors: Impact of Advances Since 2015. J Thorac Oncol. 2022 Mar;17(3):362-387. doi: 10.1016/j.jtho.2021.11.003. Epub 2021 Nov 20. |
| Label | URL |
|---|---|
| 6th LuCE Report on lung cancer. Experiences and quality of life of people impacted by lung cancer in Europe | View source |
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After recruitment has finalized
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Before surgery, seven days after surgery |
| Correlation between the type of surgical approach performed and postoperative quality of life | Measure and analyze the correlation between the type of surgical approach performed and postoperative quality of life upon completion of the surgical episode and before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). The type of surgical approach (thoracotomy, VATS or RATS), will be collected from the post-surgery report. | Before surgery, seven days after surgery |
| Correlation between the occurrence of postoperative complications and a longer hospital stay | Analyze the correlation between the occurrence of postoperative complications and a longer hospital stay with the quality of life before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). Post-surgery complications will be collected from the patient's medical record, recorded in the Jimena 4 software program. Hospital stay lenght will be collected from the patient´s hospital discharge report. | Before surgery, seven days after surgery, before the first dose of adjuvant treatment |
| Effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29 | Measure and analyze the effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29 for patients undergoing lung resection for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC), where higher score represents higher level of symptomatology or problems. | Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment |
| Adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life | Measure and analyze whether any adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life of patients who receive adjuvant treatment after undergoing lung resection compared to others. | Before the first cycle of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment |
| Correlation between the presence of Chronic Obstructive Pulmonary Disease (COPD) and postoperative quality of life | Analyze the correlation between the presence of Chronic Obstructive Pulmonary Disease (COPD) and postoperative quality of life upon completion of the surgical episode before and after receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). | Before surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment |
| Level of anxiety/depression in patients undergoing lung resection before and after receiving the first cycle of adjuvant treatment | Measure and analyze the level of anxiety/depression in patients undergoing lung resection before and after receiving the first cycle of adjuvant treatment for lung cancer. Patients will be asked to complete the HADS questionnaire. | Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment |
| Effect of Performance Status (PS) and pre-adjuvant treatment ECOG on the quality of life after receiving the first cycle of any treatment modality. | Measure and analyze the effect of Performance Status (PS) and pre-adjuvant treatment ECOG on the quality of life after receiving the first cycle of any treatment modality. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). Performance Status Score and ECOG score data will be collected from the patient's medical record, recorded in the Jimena 4 software program. | Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment |
| Marta G Fuentes Gago, MD, PhD |
| University of Salamanca |
| Study Director |
| María B García Cenador, MD, PhD | University of Salamanca | Study Chair |
| 35545176 | Background | Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D'Amico TA, DeCamp M, Dilling TJ, Dowell J, Gettinger S, Grotz TE, Gubens MA, Hegde A, Lackner RP, Lanuti M, Lin J, Loo BW, Lovly CM, Maldonado F, Massarelli E, Morgensztern D, Ng T, Otterson GA, Pacheco JM, Patel SP, Riely GJ, Riess J, Schild SE, Shapiro TA, Singh AP, Stevenson J, Tam A, Tanvetyanon T, Yanagawa J, Yang SC, Yau E, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 May;20(5):497-530. doi: 10.6004/jnccn.2022.0025. |
| 34613537 | Background | Shi Y, Wu S, Ma S, Lyu Y, Xu H, Deng L, Chen X. Comparison Between Wedge Resection and Lobectomy/Segmentectomy for Early-Stage Non-small Cell Lung Cancer: A Bayesian Meta-analysis and Systematic Review. Ann Surg Oncol. 2022 Mar;29(3):1868-1879. doi: 10.1245/s10434-021-10857-7. Epub 2021 Oct 6. |
| 17888955 | Background | Atkins BZ, Harpole DH Jr, Mangum JH, Toloza EM, D'Amico TA, Burfeind WR Jr. Pulmonary segmentectomy by thoracotomy or thoracoscopy: reduced hospital length of stay with a minimally-invasive approach. Ann Thorac Surg. 2007 Oct;84(4):1107-12; discussion 1112-3. doi: 10.1016/j.athoracsur.2007.05.013. |
| 20172539 | Background | Scott WJ, Allen MS, Darling G, Meyers B, Decker PA, Putnam JB, McKenna RW, Landrenau RJ, Jones DR, Inculet RI, Malthaner RA. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the American College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010 Apr;139(4):976-81; discussion 981-3. doi: 10.1016/j.jtcvs.2009.11.059. Epub 2010 Feb 20. |
| 19022040 | Background | Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009. |
| 18506026 | Background | Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, Dunant A, Torri V, Rosell R, Seymour L, Spiro SG, Rolland E, Fossati R, Aubert D, Ding K, Waller D, Le Chevalier T; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008 Jul 20;26(21):3552-9. doi: 10.1200/JCO.2007.13.9030. Epub 2008 May 27. |
| 19933915 | Background | Butts CA, Ding K, Seymour L, Twumasi-Ankrah P, Graham B, Gandara D, Johnson DH, Kesler KA, Green M, Vincent M, Cormier Y, Goss G, Findlay B, Johnston M, Tsao MS, Shepherd FA. Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10. J Clin Oncol. 2010 Jan 1;28(1):29-34. doi: 10.1200/JCO.2009.24.0333. Epub 2009 Nov 23. |
| 35839025 | Background | Wang SF, Mao NQ, Zhao WH, Pan XB. Postoperative radiotherapy in pIIIA-N2 non-small cell lung cancer after complete resection and adjuvant chemotherapy: A meta-analysis. Medicine (Baltimore). 2022 Jul 15;101(28):e29550. doi: 10.1097/MD.0000000000029550. |
| 29658848 | Background | Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16. |
| 34234606 | Background | Shukla N, Hanna N. Neoadjuvant and Adjuvant Immunotherapy in Early-Stage Non-Small Cell Lung Cancer. Lung Cancer (Auckl). 2021 Jun 28;12:51-60. doi: 10.2147/LCTT.S277717. eCollection 2021. |
| 32327180 | Background | Broderick SR. Adjuvant and Neoadjuvant Immunotherapy in Non-small Cell Lung Cancer. Thorac Surg Clin. 2020 May;30(2):215-220. doi: 10.1016/j.thorsurg.2020.01.001. |
| 30280635 | Background | Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gumus M, Mazieres J, Hermes B, Cay Senler F, Csoszi T, Fulop A, Rodriguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. doi: 10.1056/NEJMoa1810865. Epub 2018 Sep 25. |
| 34528869 | Background | Gabay C, Russo A, Raez LE, Rolfo Cervetto C. Adjuvant therapy in non-small cell lung cancer: is targeted therapy joining the standard of care? Expert Rev Anticancer Ther. 2021 Nov;21(11):1229-1235. doi: 10.1080/14737140.2021.1982387. Epub 2021 Sep 25. |
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| 1593914 | Background | Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. |
| 25984359 | Background | Pompili C. Quality of life after lung resection for lung cancer. J Thorac Dis. 2015 Apr;7(Suppl 2):S138-44. doi: 10.3978/j.issn.2072-1439.2015.04.40. |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |