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      Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy

      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 22 , 17 , 23 , 1

      Frontiers in Oncology

      Frontiers Media S.A.

      Chronic myeloid leukemia, ENESTPath, emotional experience, nilotinib, psychological distress, quality of life, study protocol, mixed methods

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          Achievement of deep molecular response following treatment with a tyrosine kinase inhibitor (TKI) allows for treatment-free remission (TFR) in many patients with chronic myeloid leukemia (CML). Successful TFR is defined as the achievement of a sustained molecular response after cessation of ongoing TKI therapy. The phase 3 ENESTPath study was designed to determine the required optimal duration of consolidation treatment with the second-generation TKI, nilotinib 300 mg twice-daily, to remain in successful TFR without relapse after entering TFR for 12 months. The purpose of this Italian ‘patient’s voice CML’ substudy was to evaluate patients’ psycho-emotional characteristics and quality of life through their experiences of stopping treatment with nilotinib and entering TFR. The purpose of the present contribution is to early present the study protocol of an ongoing study to the scientific community, in order to describe the study rationale and to extensively present the study methodology. Patients aged ≥18 years with a confirmed diagnosis of Philadelphia chromosome positive BCR-ABL1+ CML in chronic phase and treated with front-line imatinib for a minimum of 24 months from the enrollment were eligible. Patients consenting to participate the substudy will have quality of life questionnaires and in-depth qualitative interviews conducted. The substudy will include both qualitative and quantitative design aspects to evaluate the psychological outcomes as assessed via patients’ emotional experience during and after stopping nilotinib therapy. Randomization is hypothesized to be a timepoint of higher psychological alert or distress when compared to consolidation and additionally any improvement in health-related quality of life (HRQoL) due to nilotinib treatment is expected across the timepoints (from consolidation, to randomization, and TFR). An association is also expected between dysfunctional coping strategies, such as detachments and certain personality traits, and psychological distress and HRQoL impairments. Better HRQoL outcomes are expected in TFR compared to the end of consolidation. This substudy is designed for in-depth assessment of all potential psycho-emotional variables and aims to determine the need for personalized patient care and counselling, and also guide clinicians to consider the psychological well-being of patients who are considering treatment termination.

          NCT number: NCT01743989, EudraCT number: 2012-005124-15

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          Most cited references 69

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            We developed a multidimensional coping inventory to assess the different ways in which people respond to stress. Five scales (of four items each) measure conceptually distinct aspects of problem-focused coping (active coping, planning, suppression of competing activities, restraint coping, seeking of instrumental social support); five scales measure aspects of what might be viewed as emotional-focused coping (seeking of emotional social support, positive reinterpretation, acceptance, denial, turning to religion); and three scales measure coping responses that arguably are less useful (focus on and venting of emotions, behavioral disengagement, mental disengagement). Study 1 reports the development of scale items. Study 2 reports correlations between the various coping scales and several theoretically relevant personality measures in an effort to provide preliminary information about the inventory's convergent and discriminant validity. Study 3 uses the inventory to assess coping responses among a group of undergraduates who were attempting to cope with a specific stressful episode. This study also allowed an initial examination of associations between dispositional and situational coping tendencies.
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              Chronic myeloid leukaemia as a model of disease evolution in human cancer.

              Chronic myeloid leukaemia (CML) can be considered as a paradigm for neoplasias that evolve through a multi-step process. CML is also one of the best examples of a disease that can be targeted by molecular therapy; however, the success of new 'designer drugs' is largely restricted to the chronic phase of the disease. If not cured at this stage, CML invariably progresses and transforms into an acute-type leukaemia undergoing a 'blast crisis'. The causes of this transformation are still poorly understood. What mechanisms underlie this progression, and are they shared by other common cancers?

                Author and article information

                Front Oncol
                Front Oncol
                Front. Oncol.
                Frontiers in Oncology
                Frontiers Media S.A.
                26 May 2021
                : 11
                1 Department of Health Sciences, University of Milan , Milan, Italy
                2 Department of Hematology-Oncology, L. and A. Seràgnoli, University of Bologna, S. Orsola-Malpighi Hospital , Bologna, Italy
                3 Hematology Division, Hospital S.G. Moscati , Taranto, Italy
                4 Department of Translational and Precision Medicine, University Sapienza Rome - Azienda Policlinico Umberto I , Rome, Italy
                5 Department of Hematology, Vicenza Hospital , Vicenza, Italy
                6 Hematology Division, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico , Milan, Italy
                7 Department of Hematology, Spirito Santo Hospital , Pescara, Italy
                8 Institute of Hematology-Centro di Ricerche Emato-Oncologiche, Department of Medicine, University of Perugia , Perugia, Italy
                9 Department of Emergency and Organ Transplantation, Hematology Section, University of Bari , Bari, Italy
                10 Department of Clinical and Experimental Medicine, Section of Hematology, University of Pisa , Pisa, Italy
                11 Hematology Unit, Nocera Inferiore Hospital , Nocera Inferiore, Italy
                12 Division of Hematology and Internal Medicine, San Luigi Gonzaga University Hospital, Orbassano, University of Turin , Turin, Italy
                13 Division of Hematology, AUSL-IRCCS Reggio Emilia , Reggio Emilia, Italy
                14 Institute of Hematology, University of Ferrara , Ferrara, Italy
                15 Department of Medicine, Section of Hematology, University of Verona , Verona, Italy
                16 Fondazione Policlinico Universitario Agostino Gemelli – IRCSS, Università Cattolica del Sacro Cuore , Rome, Italy
                17 Department of Hematology Oncology, IRCCS S. Matteo Hospital Foundation , Pavia, Italy
                18 Department of Oncology, Azienda Toscana Nord Ovest , Livorno, Italy
                19 Department of Oncology and Hematology, Aulss 3 Serenissima , Venice, Italy
                20 Hematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute , Milano, Italy
                21 Division of Hematology and BMT Center AOU Parma , Parma, Italy
                22 Oncology Region Europe, Novartis Farma SpA , Origgio, Italy
                23 Department of Hematology and Oncology “L. and A. Seràgnoli”, University of Bologna , Bologna, Italy
                Author notes

                Edited by: Robert Ohgami, University of California, San Francisco, United States

                Reviewed by: Abhishek Maiti, University of Texas MD Anderson Cancer Center, United States ; Valentin Garcia-Gutierrez, Ramón y Cajal University Hospital, Spain

                *Correspondence: Lidia Borghi, lidia.borghi@ 123456unimi.it

                This article was submitted to Hematologic Malignancies, a section of the journal Frontiers in Oncology

                Copyright © 2021 Borghi, Rosti, Maggi, Breccia, Di Bona, Iurlo, La Barba, Sportoletti, Albano, Galimberti, Rivellini, Cambrin, Capodanno, Cuneo, Bonifacio, Sica, Arcaini, Capochiani, Minotto, Ciceri, Crugnola, Di Caprio, Supekar, Elena, Baccarani and Vegni

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                Page count
                Figures: 2, Tables: 0, Equations: 0, References: 71, Pages: 9, Words: 4486


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