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      A Case-Control Analysis of the Impact of Venous Thromboembolic Disease on Quality of Life of Patients with Cancer: Quality of Life in Cancer (Qca) Study

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          Abstract

          Although there is published research on the impact of venous thromboembolism (VTE) on quality of life (QoL), this issue has not been thoroughly investigated in patients with cancer—particularly using specific questionnaires. We aimed to examine the impact of acute symptomatic VTE on QoL of patients with malignancies. This was a multicenter, prospective, case-control study conducted in patients with cancer either with (cases) or without (controls) acute symptomatic VTE. Participants completed the EORTC QLQ-C30, EQ-5D-3L, PEmb-QoL, and VEINES-QOL/Sym questionnaires. Statistically significant and clinically relevant differences in terms of global health status were examined. Between 2015 and 2018, we enrolled 425 patients (128 cases and 297 controls; mean age: 60.2 ± 18.4 years). The most common malignancies were gastrointestinal (23.5%) and lung (19.8%) tumors. We found minimally important differences in global health status on the EQ-5D-3L (cases versus controls: 0.55 versus 0.77; mean difference: −0.22) and EORTC QLQ-C30 (47.7 versus 58.4; mean difference: −10.3) questionnaires. There were minimally important differences on the PEmb-QoL questionnaire (44.4 versus 23; mean difference: −21.4) and a significantly worse QoL on the VEINES-QOL/Sym questionnaire (42.7 versus 51.7; mean difference: −9). In conclusion, we showed that acute symptomatic VTE adversely affects the QoL of patients with malignancies.

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          Interpreting the significance of changes in health-related quality-of-life scores.

          To determine the significance to patients of changes in health-related quality-of-life (HLQ) scores assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). A subjective significance questionnaire (SSQ), which asks patients about perceived changes in physical, emotional, and social functioning and in global quality of life (global QL) and the QLQ-C30 were completed by patients who received chemotherapy for either breast cancer or small-cell lung cancer (SCLC). In the SSQ, patients rated their perception of change since the last time they completed the QLQ-C30 using a 7-category scale that ranged from "much worse" through "no change" to "much better." For each category of change in the SSQ, the corresponding differences were calculated in QLQ-C30 mean scores and effect sizes were determined. For patients who indicated "no change" in the SSQ, the mean change in scores in the corresponding QLQ-C30 domains was not significantly different from 0. For patients who indicated "a little" change either for better or for worse, the mean change in scores was about 5 to 10; for "moderate" change, about 10 to 20; and for "very much" change, greater than 20. Effect sizes increased in concordance with increasing changes in SSQ ratings and QLQ-C30 scores. The significance of changes in QLQ-C30 scores can be interpreted in terms of small, moderate, or large changes in quality of life as reported by patients in the SSQ. The magnitude of these changes also can be used to calculate the sample sizes required to detect a specified change in clinical trials.
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            Quality of life research within the EORTC—the EORTC QLQ-C30

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              Epidemiology and pathophysiology of cancer-associated thrombosis

              Venous thromboembolism (VTE) is a common complication in patients with malignant disease. First recognised by Bouillard in 1823 and later described by Trousseau in 1844, multiple studies have since provided considerable evidence for a clinical association between VTE and cancer. Across all cancers, the risk for VTE is elevated 7-fold; in certain malignancies, the risk for VTE may be increased up to 28-fold. Venous thromboembolism is the second leading cause of death in patients with cancer; among survivors, complications commonly include recurrent VTE and post-thrombotic syndrome, and (more rarely) chronic thromboembolic pulmonary hypertension, which are costly, and have a profound impact on the patient's quality of life. Tumour cells can activate blood coagulation through multiple mechanisms, including production of procoagulant, fibrinolytic, and proaggregating activities, release of proinflammatory and proangiogenic cytokines, and interacting directly with host vascular and blood cells (e.g., endothelial cells, leukocytes, and platelets) through adhesion molecules. Increasing evidence suggests that elements of the haemostatic system also have a direct role in eliciting or enhancing angiogenesis, cell survival, and metastasis. Despite the problem posed by VTE in the setting of cancer, it is evident that a significant number of oncologists do not recognise the link between cancer, its treatment, and thrombogenesis. On 22 May 2009, a group of UK-based physicians met in London, UK, to evaluate recent data on cancer thrombosis. This article (1 of 4) briefly reviews key data on the epidemiology and pathophysiology of VTE as a context for a discussion and consensus statement developed by meeting attendees, on the implications of this information for UK clinical practice.
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                Author and article information

                Journal
                Cancers (Basel)
                Cancers (Basel)
                cancers
                Cancers
                MDPI
                2072-6694
                26 December 2019
                January 2020
                : 12
                : 1
                : 75
                Affiliations
                [1 ]Respiratory Department, Medical Surgical Unit of Respiratory Diseases, Hospital Virgen del Rocio, CIBERES, 41013 Sevilla, Spain; luciamarinb@ 123456gmail.com (L.M.-B.); teresaelias@ 123456telefonica.net (T.E.-H.); miacruz06@ 123456hotmail.com (M.I.A.-C.); rotero@ 123456separ.es (R.O.)
                [2 ]Medical Oncology Department, Hospital General Universitario Gregorio Marañón, 28009 Madrid, Spain; andresmunmar@ 123456hotmail.com (A.J.M.-M.); iriagallegog@ 123456gmail.com (I.G.); tripleg87@ 123456yahoo.es (G.G.-G.)
                [3 ]Hematology and Hemotherapy Department, Hospital Universitario Virgen de Valme, 41701 Sevilla, Spain; eriosh@ 123456gmail.com
                [4 ]Medical Oncology Department, HGU de Ciudad Real, 13003 Ciudad Real, Spain; naxto@ 123456hotmail.com
                [5 ]Medical Oncology Department, Hospital Universitario Virgen Macarena, 41009 Sevilla, Spain; cbeatoz@ 123456hotmail.com
                [6 ]Medical Oncology Department, DIBAPS/Translational Genomics and Targeted Therapeutics in Solid Tumors, Hospital Clínic, 08036 Barcelona, Spain; carme.fontpuig@ 123456gmail.com
                [7 ]Emergency Department, Hospital Virgen Macarena, 41009 Sevilla, Spain; estefania.oncala@ 123456gmail.com
                [8 ]Medical Oncology Department, Hospital Universitario Central de Asturias, 33611 Oviedo, Spain; revuelta.al@ 123456gmail.com
                [9 ]Medical Oncology Department, Hospital de Orense, 32616 Orense, Spain; karmeleareses@ 123456hotmail.com
                [10 ]Medical Oncology Department, Hospital de Jerez de la Frontera, 11407 Cádiz, Spain; victorjjrivas@ 123456hotmail.com
                [11 ]Medical Oncology Department, H. U. Puerto Real, 11510 Cádiz, Spain; angeles.moreno@ 123456uca.es
                [12 ]Respiratory Department, Hospital de Galdakao-Usansolo, 48960 Bizkaia, Spain; aitor.ballazquincoces@ 123456osakidetza.net (A.B.-Q.); leyrech10@ 123456gmail.com (L.C.-E.)
                [13 ]Internal Medicine Unit. H. U. Puerto Real, 11510 Cádiz, Spain; juanbosco.lopez@ 123456gm.uca.es
                [14 ]Medical Oncology Department, Hospital Virgen del Rocio, 41013 Sevilla, Spain; puriestevez@ 123456gmail.com
                [15 ]Respiratory Department, Hospital Universitario Virgen de Valme, 41701 Sevilla, Spain; jorgelial@ 123456hotmail.com
                Author notes
                [* ]Correspondence: luisoneumo@ 123456hotmail.com ; Tel.: +34-6-67-95-64-80; Fax: +34-9-55-01-21-90
                Author information
                https://orcid.org/0000-0001-6977-8249
                https://orcid.org/0000-0002-1068-0455
                https://orcid.org/0000-0002-4125-3376
                Article
                cancers-12-00075
                10.3390/cancers12010075
                7017186
                31888065
                7185692e-4aab-4bc3-8553-e3007be80b1c
                © 2019 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 04 December 2019
                : 24 December 2019
                Categories
                Article

                neoplasm,quality of life,venous thromboembolism,pulmonary embolism,venous thrombosis

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