Team Science in Surgical Oncologic Care
.jpeg.jpg "Eduard-Alexandru Bonci, MD PhD (he/him/his) photo")
Eduard-Alexandru Bonci, MD PhD (he/him/his)
Breast Surgical Oncology and Clinical Research Fellow
Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal); Surgical Oncology and Gynecologic Oncology Department, Iuliu Hatieganu University of Medicine and Pharmacy (Cluj-Napoca, Romania)
Lisbon, Lisboa, Portugal
Eduard-Alexandru Bonci, MD PhD (he/him/his)
Breast Surgical Oncology and Clinical Research Fellow
Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal); Surgical Oncology and Gynecologic Oncology Department, Iuliu Hatieganu University of Medicine and Pharmacy (Cluj-Napoca, Romania)
Lisbon, Lisboa, Portugal
Eduard-Alexandru Bonci, MD PhD (he/him/his)
Breast Surgical Oncology and Clinical Research Fellow
Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal); Surgical Oncology and Gynecologic Oncology Department, Iuliu Hatieganu University of Medicine and Pharmacy (Cluj-Napoca, Romania)
Lisbon, Lisboa, Portugal
Orit Kaidar-Person, n/a
Head of Breast Cancer Radiation Unit
Breast Cancer Radiation Therapy Unit, Sheba Medical Center (Ramat Gan, Israel); School of Medicine, Tel-Aviv University (Tel-Aviv, Israel), Israel
Marília Antunes, n/a
Professor
Faculdade de Ciências, Universidade de Lisboa (Lisbon, Portugal); CEAUL - Centro de Estatística e Aplicações, Faculdade de Ciências, Universidade de Lisboa (Lisbon, Portugal), Portugal
Oriana Ciani, n/a
Associate Professor
Center for Research on Health and Social Care Management (CERGAS), SDA Bocconi University (Milan, Italy), Italy
Helena Cruz, n/a
Project Manager
Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal), Portugal
Rosa Di Micco, n/a
Breast surgeon
Breast Surgery Unit, San Raffaele University and Research Hospital (Milan, Italy), Italy
Oreste Gentilini, n/a
Head of Breast Surgery Unit and Head of Breast Unit
Breast Surgery Unit, San Raffaele University and Research Hospital (Milan, Italy), Italy
Jörg Heil, n/a
Professor
Department of Obstetrics & Gynecology, Heidelberg University Hospital (Heidelberg, Germany), Germany
Pawel Kabata, n/a
Breast Surgeon
Department of Surgical Oncology, Faculty of Medicine, Medical University of Gdańsk (Gdańsk, Poland), Poland
Miguel Romariz, n/a
Research Assistant
INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); FCUP - Faculty of Sciences, University of Porto (Porto, Portugal), Portugal
Tiago Gonçalves, n/a
Research Assistant
INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); FEUP - Faculty of Engineering, University of Porto (Porto, Portugal), Portugal
Henrique Martins, n/a
Associate Professor
Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal); ISCTE - Instituto Universitário de Lisboa (Lisbon, Portugal), Portugal
Ludovica Borsoi, n/a
Research Fellow
Center for Research on Health and Social Care Management (CERGAS), SDA Bocconi University (Milan, Italy), Italy
Martin Mika, n/a
Manager
CANKADO GmbH (Ottobrunn, Germany), Germany
André Pfob, n/a
MD
Department of Obstetrics & Gynecology, Heidelberg University Hospital (Heidelberg, Germany), Germany
Natalie Romem, n/a
Project Manager
Breast Cancer Radiation Therapy Unit, Sheba Medical Center (Ramat Gan, Israel), Israel
Timo Schinköthe, n/a
CEO
CANKADO GmbH (Ottobrunn, Germany); Research Center Smart Digital Health, University of the Bundeswehr Munich (Neubiberg, Germany), Germany
Giovani Silva, n/a
Assistant Professor
CEAUL - Centro de Estatística e Aplicações, Faculdade de Ciências, Universidade de Lisboa (Lisbon, Portugal); Instituto Superior Técnico, Universidade de Lisboa (Lisbon, Portugal), Portugal
Elżbieta Senkus, n/a
Associate Professor
Department of Oncology and Radiotherapy, Faculty of Medicine, Medical University of Gdańsk (Gdańsk, Poland), Poland
Maria-Joao Cardoso, n/a
Head Breast Surgeon
Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal); Faculdade de Medicina da Universidade de Lisboa (Lisbon, Portugal), Portugal
Most breast cancer patients are diagnosed at an early stage. Different locoregional approaches offer patients similar disease outcomes but variable aesthetic outcomes that may lead to disappointment and poor quality of life (QoL). There are no standardized methods to inform patients of the different therapies prior to intervention, nor validated tools for evaluation of aesthetics and patients' expectations. The CINDERELLA Project aims to provide an artificial intelligence (AI) tool to aid shared decision-making by showing breast cancer patients the predicted aesthetic outcomes of different locoregional treatments. The clinical trial will evaluate the use of this tool within an AI cloud-based platform approach (CINDERELLA App) versus a standard approach.
Methods:
Trial design: international multicentric interventional randomized controlled open-label clinical trial. Using the CINDERELLA App, the patient will have access to supervised medical information approved by breast cancer experts, and the AI system will match patient's information to pictures showing the potential aesthetic outcome (spectrum of good-poor) according to different locoregional approach. The Control arm will follow the standard approach for achieving informed consent of each clinical site.
Eligibility criteria: patients diagnosed with primary breast cancer without evidence of systemic disease proposed for breast conserving surgery or mastectomy with immediate breast reconstruction.
Specific aims: to assess the levels of agreement among patients' expectations regarding the aesthetic outcome before and 1 year after locoregional treatment. The trial will also evaluate the aesthetic outcome level of agreement between the AI evaluation tool and self-evaluation, health-related QoL and resource consumption.
Statistical methods: Wilcoxon signed rank test will be used to assess the intervention's impact on the agreement level between expectations and outcomes. Statistical tests and/or bootstrap techniques will compare results between arms. Questionnaires will be evaluated based on provided scoring guidelines.
Results:
The clinical trial will enroll a minimum of 515 patients in each arm. Recruitment has started on August 8th 2023, and is currently open at 5 study sites in Germany, Israel, Italy, Poland and Portugal.
Conclusions:
We anticipate that the CINDERELLA App will lead to improved satisfaction, psychosocial well-being and health-related QoL while maintaining the quality of care and providing environmental and economic benefits.