Predicting Effective Adaptation to Breast Cancer to Help Women BOUNCE Back: Protocol for a Multicenter Clinical Pilot Study.

Autor:	Pettini G; Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan, Italy., Sanchini V; Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.; Department of Public Health and Primary Care, Centre for Biomedical Ethics and Law, KU Leuven, Leuven, Belgium., Pat-Horenczyk R; Paul Baerwald School of Social Work and Social Welfare, The Hebrew University of Jerusalem, Jerusalem, Israel., Sousa B; Breast Unit, Champalimaud Clinical Centre/Champalimaud Foundation, Lisboa, Portugal., Masiero M; Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan, Italy.; Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy., Marzorati C; Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan, Italy., Galimberti VE; Division of Breast Surgery, European Institute of Oncology, IRCCS, Milan, Italy., Munzone E; Division of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy., Mattson J; Department of Oncology, Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland., Vehmanen L; Department of Oncology, Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland., Utriainen M; Department of Oncology, Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland., Roziner I; Department of Communication Disorders, The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel., Lemos R; Champalimaud Research and Clinical Centre, Champalimaud Foundation, Lisboa, Portugal.; ISPA, Instituto Universitário, Lisboa, Portugal., Frasquilho D; Breast Unit, Champalimaud Clinical Centre/Champalimaud Foundation, Lisboa, Portugal., Cardoso F; Breast Unit, Champalimaud Clinical Centre/Champalimaud Foundation, Lisboa, Portugal., Oliveira-Maia AJ; Champalimaud Research and Clinical Centre, Champalimaud Foundation, Lisboa, Portugal.; NOVA Medical School, NMS, Universidade Nova de Lisboa, Lisboa, Portugal., Kolokotroni E; In Silico Oncology and In Silico Medicine Group, Institute of Communication and Computer Systems, Athens, Greece.; School of Electrical and Computer Engineering, Athens, Greece.; National Technical University of Athens, Athens, Greece., Stamatakos G; In Silico Oncology and In Silico Medicine Group, Institute of Communication and Computer Systems, Athens, Greece.; School of Electrical and Computer Engineering, Athens, Greece.; National Technical University of Athens, Athens, Greece., Leskelä RL; Nordic Healthcare Group, Helsinki, Finland., Haavisto I; Nordic Healthcare Group, Helsinki, Finland., Salonen J; Varian Medical System, Helsinki, Finland., Richter R; Varian Medical System, Helsinki, Finland., Karademas E; Department of Psychology, University of Crete, Crete, Greece.; Foundation for Research and Technology - Hellas, Heraklion, Greece., Poikonen-Saksela P; Department of Oncology, Comprehensive Cancer Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland., Mazzocco K; Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan, Italy.; Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2022 Oct 12; Vol. 11 (10), pp. e34564. Date of Electronic Publication: 2022 Oct 12.
DOI:	10.2196/34564
Abstrakt:	Background: Despite the continued progress of medicine, dealing with breast cancer is becoming a major socioeconomic challenge, particularly due to its increasing incidence. The ability to better manage and adapt to the entire care process depends not only on the type of cancer but also on the patient's sociodemographic and psychological characteristics as well as on the social environment in which a person lives and interacts. Therefore, it is important to understand which factors may contribute to successful adaptation to breast cancer. To our knowledge, no studies have been performed on the combination effect of multiple psychological, biological, and functional variables in predicting the patient's ability to bounce back from a stressful life event, such as a breast cancer diagnosis. Here we describe the study protocol of a multicenter clinical study entitled "Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back" or, in short, BOUNCE. Objective: The aim of the study is to build a quantitative mathematical model of factors associated with the capacity for optimal adjustment to cancer and to study resilience through the cancer continuum in a population of patients with breast cancer. Methods: A total of 660 women with breast cancer will be recruited from five European cancer centers in Italy, Finland, Israel, and Portugal. Biomedical and psychosocial variables will be collected using the Noona Healthcare platform. Psychosocial, sociodemographic, lifestyle, and clinical variables will be measured every 3 months, starting from presurgery assessment (ie, baseline) to 18 months after surgery. Temporal data mining, time-series prediction, sequence classification methods, clustering time-series data, and temporal association rules will be used to develop the predictive model. Results: The recruitment process stared in January 2019 and ended in November 2021. Preliminary results have been published in a scientific journal and are available for consultation on the BOUNCE project website. Data analysis and dissemination of the study results will be performed in 2022. Conclusions: This study will develop a predictive model that is able to describe individual resilience and identify different resilience trajectories along the care process. The results will allow the implementation of tailored interventions according to patients' needs, supported by eHealth technologies. Trial Registration: ClinicalTrials.gov NCT05095675; https://clinicaltrials.gov/ct2/show/NCT05095675. International Registered Report Identifier (irrid): DERR1-10.2196/34564. (©Greta Pettini, Virginia Sanchini, Ruth Pat-Horenczyk, Berta Sousa, Marianna Masiero, Chiara Marzorati, Viviana Enrica Galimberti, Elisabetta Munzone, Johanna Mattson, Leena Vehmanen, Meri Utriainen, Ilan Roziner, Raquel Lemos, Diana Frasquilho, Fatima Cardoso, Albino J Oliveira-Maia, Eleni Kolokotroni, Georgios Stamatakos, Riikka-Leena Leskelä, Ira Haavisto, Juha Salonen, Robert Richter, Evangelos Karademas, Paula Poikonen-Saksela, Ketti Mazzocco. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 12.10.2022.)
Databáze:	MEDLINE
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