Pettini Greta, Sanchini Virginia, Pat-Horenczyk Ruth, Sousa Berta, Masiero Marianna, Marzorati Chiara, Galimberti Viviana Enrica, Munzone Elisabetta, Mattson Johanna, Vehmanen Leena, Utriainen Meri, Roziner Ilan, Lemos Raquel, Frasquilho Diana, Cardoso Fatima, Oliveira-Maia Albino J, Kolokotroni Eleni, Stamatakos Georgios, Leskelä Riikka-Leena, Haavisto Ira, Salonen Juha, Richter Robert, Karademas Evangelos, Poikonen-Saksela Paula, Mazzocco Ketti
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.
JMIR Res Protoc. 2022 Oct 12;11(10):e34564. doi: 10.2196/34564.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT05095675; https://clinicaltrials.gov/ct2/show/NCT05095675.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34564.
尽管医学不断进步，但应对乳腺癌正成为一项重大的社会经济挑战，尤其是由于其发病率不断上升。更好地管理和适应整个护理过程的能力不仅取决于癌症类型，还取决于患者的社会人口统计学和心理特征，以及患者生活和互动的社会环境。因此，了解哪些因素可能有助于成功适应乳腺癌很重要。据我们所知，尚未有研究探讨多种心理、生物和功能变量在预测患者从诸如乳腺癌诊断等应激性生活事件中恢复过来的能力方面的联合作用。在此，我们描述一项多中心临床研究的方案，该研究名为“预测对乳腺癌的有效适应以帮助女性恢复活力”，简称为“BOUNCE”。
本研究的目的是建立一个与癌症最佳适应能力相关因素的定量数学模型，并在乳腺癌患者群体中通过癌症连续过程研究恢复力。
将从意大利、芬兰、以色列和葡萄牙的五个欧洲癌症中心招募总共660名乳腺癌女性患者。将使用Noona医疗保健平台收集生物医学和心理社会变量。从术前评估（即基线）到术后18个月，每3个月测量一次心理社会、社会人口统计学、生活方式和临床变量。将使用时间数据挖掘、时间序列预测、序列分类方法、聚类时间序列数据和时间关联规则来开发预测模型。
招募过程于2019年1月开始，2021年11月结束。初步结果已发表在一份科学期刊上，可在BOUNCE项目网站上查阅。研究结果的数据分析和传播将于2022年进行。
本研究将开发一个预测模型，该模型能够描述个体恢复力，并识别整个护理过程中的不同恢复力轨迹。研究结果将有助于在电子健康技术的支持下，根据患者需求实施个性化干预措施。
ClinicalTrials.gov NCT05095675；https://clinicaltrials.gov/ct2/show/NCT05095675。
国际注册报告标识符（IRRID）：DERR1-10.2196/34564。
