{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,5,3]],"date-time":"2024-05-03T00:37:55Z","timestamp":1714696675387},"reference-count":0,"publisher":"American Association for Cancer Research (AACR)","issue":"9_Supplement","content-domain":{"domain":["aacrjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,5,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Background. Breast cancer treatment has improved overall survival rates, with different locoregional approaches offering patients similar locoregional control but variable aesthetic outcomes that may lead to disappointment and poor quality of life (QoL). There are no standardized methods for informing patients of the different therapies prior to intervention, nor validated tools for evaluation of aesthetics and patients' expectations. The CINDERELLA Project is based on years of research and developments of new healthcare technologies by various partners, aimed to provide an artificial intelligence (AI) tool to aid shared decision-making by showing breast cancer patients the predicted aesthetic outcomes of their locoregional treatment. The clinical trial will evaluate the use of this tool within an AI cloud-based platform approach (CINDERELLA App) versus a standard approach. 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.<\/jats:p>\n               <jats:p>Trial design. CINDERELLA is an international multicentric interventional randomized controlled open-label clinical trial. Using the CINDERELLA App, the AI and Digital Health arm will provide patients with complete information about the proposed types of locoregional treatments and photographs of similar patients previously treated with the same techniques. The Control arm will follow the standard approach of each clinical site. Randomization will be conducted online using the digital health platform CANKADO, ensuring a balanced distribution of participants between the two groups. CANKADO is the underlying platform through which physicians control the patients' app content and conduct all data collection. Privacy, data protection and ethical principles in AI usage were taken into account.<\/jats:p>\n               <jats:p>Eligibility criteria. Patients diagnosed with primary breast cancer without evidence of systemic disease. All patients must sign an informed consent and be able to use a web-based app autonomously or with home-based support.<\/jats:p>\n               <jats:p>Specific aims. Primary objective: to assess the levels of agreement among patients' expectations regarding the aesthetic outcome before and 12 months after locoregional treatment. The trial will also evaluate the aesthetic outcome level of agreement between the AI evaluation tool and self-evaluation. Secondary objectives: health-related QoL (EQ-5D-5L and BREAST-Q ICHOM questionnaires) and resource consumption (e.g., time spent in the hospital, out-of-pocket expenses). The questionnaires and photographs will be applied prior to any treatment, at wound healing, at 6 and 12 months following the completion of locoregional therapy.<\/jats:p>\n               <jats:p>Statistical methods. Wilcoxon signed rank test will be used to assess the intervention's impact on the agreement level between expectations and obtained results. Weighted Cohen's kappa will be calculated to measure the improvement in classifying aesthetic results with intervention. Statistical tests and\/or bootstrap techniques will compare results between arms. A similarity measure will be calculated between self-evaluation and outcome obtained with the AI tool for each participant, and a beta regression model will be used to analyze the intervention's effect. Secondary objectives will be evaluated by scoring questionnaires based on provided guidelines.<\/jats:p>\n               <jats:p>Target accrual. The clinical trial, led by Champalimaud Clinical Centre, will enroll a minimum of 515 patients in each arm between July 2023 and January 2025. Recruitment is currently open at five study sites in Germany, Israel, Italy, Poland and Portugal. The clinical trial is still open for further international study sites.<\/jats:p>\n               <jats:p>Funding. European Union grant HORIZON-HLTH-2021-DISEASE-04-04 Agreement No. 101057389.<\/jats:p>\n               <jats:p>Citation Format: Eduard-Alexandru Bonci, Orit Kaidar-Person, Mar\u00edlia Antunes, Oriana Ciani, Helena Cruz, Rosa Di Micco, Oreste Davide Gentilini, Nicole Rotmensz, Pedro Gouveia, J\u00f6rg Heil, Pawel Kabata, Nuno Freitas, Tiago Gon\u00e7alves, Miguel Romariz, Helena Montenegro, H\u00e9lder P. Oliveira, Jaime S. Cardoso, Henrique Martins, Daniela Lopes, Marta Martinho, Ludovica Borsoi, Elisabetta Listorti, Carlos Mavioso, Martin Mika, Andr\u00e9 Pfob, Timo Schink\u00f6the, Giovani Silva, Maria-Joao Cardoso. CINDERELLA Clinical Trial (NCT05196269): using artificial intelligence-driven healthcare to enhance breast cancer locoregional treatment decisions [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-19-11.<\/jats:p>","DOI":"10.1158\/1538-7445.sabcs23-po3-19-11","type":"journal-article","created":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T06:47:03Z","timestamp":1714632423000},"page":"PO3-19-11-PO3-19-11","update-policy":"http:\/\/dx.doi.org\/10.1158\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Abstract PO3-19-11: CINDERELLA Clinical Trial (NCT05196269): using artificial intelligence-driven healthcare to enhance breast cancer locoregional treatment decisions"],"prefix":"10.1158","volume":"84","author":[{"given":"Eduard-Alexandru","family":"Bonci","sequence":"first","affiliation":[{"name":"1Breast 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), Lisboa, Lisboa, Portugal,"}]},{"given":"Orit","family":"Kaidar-Person","sequence":"additional","affiliation":[{"name":"2Breast Cancer Radiation Therapy Unit, Sheba Medical Center (Ramat Gan, Israel); Sackler School of Medicine, Tel-Aviv University (Tel-Aviv, Israel),"}]},{"given":"Mar\u00edlia","family":"Antunes","sequence":"additional","affiliation":[{"name":"3Faculdade de Ci\u00eancias, Universidade de Lisboa (Lisbon, Portugal); CEAUL - Centro de Estat\u00edstica e Aplica\u00e7\u00f5es, Faculdade de Ci\u00eancias, Universidade de Lisboa (Lisbon, Portugal),"}]},{"given":"Oriana","family":"Ciani","sequence":"additional","affiliation":[{"name":"4Center for Research on Health and Social Care Management (CERGAS), SDA Bocconi University (Milan, Italy),"}]},{"given":"Helena","family":"Cruz","sequence":"additional","affiliation":[{"name":"5Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal),"}]},{"given":"Rosa Di","family":"Micco","sequence":"additional","affiliation":[{"name":"6Breast Surgery Unit, San Raffaele University and Research Hospital (Milan, Italy), Italy,"}]},{"given":"Oreste Davide","family":"Gentilini","sequence":"additional","affiliation":[{"name":"7Breast Surgery Unit, San Raffaele University Hospital, Italy,"}]},{"given":"Nicole","family":"Rotmensz","sequence":"additional","affiliation":[{"name":"8Breast Surgery Unit, San Raffaele University and Research Hospital (Milan, Italy),"}]},{"given":"Pedro","family":"Gouveia","sequence":"additional","affiliation":[{"name":"9Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal); Faculdade de Medicina da Universidade de Lisboa (Lisbon, Portugal),"}]},{"given":"J\u00f6rg","family":"Heil","sequence":"additional","affiliation":[{"name":"10Department of Obstetrics & Gynecology, Heidelberg University Hospital (Heidelberg, Germany),"}]},{"given":"Pawel","family":"Kabata","sequence":"additional","affiliation":[{"name":"11Department of Surgical Oncology, Faculty of Medicine, Medical University of Gda\u0144sk (Gda\u0144sk, Poland),"}]},{"given":"Nuno","family":"Freitas","sequence":"additional","affiliation":[{"name":"12INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); FCUP - Faculty of Sciences, University of Porto (Porto, Portugal),"}]},{"given":"Tiago","family":"Gon\u00e7alves","sequence":"additional","affiliation":[{"name":"13INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); FEUP - Faculty of Engineering, University of Porto (Porto, Portugal),"}]},{"given":"Miguel","family":"Romariz","sequence":"additional","affiliation":[{"name":"12INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); FCUP - Faculty of Sciences, University of Porto (Porto, Portugal),"}]},{"given":"Helena","family":"Montenegro","sequence":"additional","affiliation":[{"name":"13INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); FEUP - Faculty of Engineering, University of Porto (Porto, Portugal),"}]},{"given":"H\u00e9lder P.","family":"Oliveira","sequence":"additional","affiliation":[{"name":"12INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); FCUP - Faculty of Sciences, University of Porto (Porto, Portugal),"}]},{"given":"Jaime S.","family":"Cardoso","sequence":"additional","affiliation":[{"name":"13INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); FEUP - Faculty of Engineering, University of Porto (Porto, Portugal),"}]},{"given":"Henrique","family":"Martins","sequence":"additional","affiliation":[{"name":"14Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal); ISCTE - Instituto Universit\u00e1rio de Lisboa (Lisbon, Portugal),"}]},{"given":"Daniela","family":"Lopes","sequence":"additional","affiliation":[{"name":"5Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal),"}]},{"given":"Marta","family":"Martinho","sequence":"additional","affiliation":[{"name":"5Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal),"}]},{"given":"Ludovica","family":"Borsoi","sequence":"additional","affiliation":[{"name":"4Center for Research on Health and Social Care Management (CERGAS), SDA Bocconi University (Milan, Italy),"}]},{"given":"Elisabetta","family":"Listorti","sequence":"additional","affiliation":[{"name":"4Center for Research on Health and Social Care Management (CERGAS), SDA Bocconi University (Milan, Italy),"}]},{"given":"Carlos","family":"Mavioso","sequence":"additional","affiliation":[{"name":"5Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal),"}]},{"given":"Martin","family":"Mika","sequence":"additional","affiliation":[{"name":"15CANKADO GmbH (Ottobrunn, Germany),"}]},{"given":"Andr\u00e9","family":"Pfob","sequence":"additional","affiliation":[{"name":"10Department of Obstetrics & Gynecology, Heidelberg University Hospital (Heidelberg, Germany),"}]},{"given":"Timo","family":"Schink\u00f6the","sequence":"additional","affiliation":[{"name":"16CANKADO GmbH, Digital Health, Alte Landstra\u00dfe 23, 85521, Ottobrunn, Germany,"}]},{"given":"Giovani","family":"Silva","sequence":"additional","affiliation":[{"name":"17CEAUL - Centro de Estat\u00edstica e Aplica\u00e7\u00f5es, Faculdade de Ci\u00eancias, Universidade de Lisboa (Lisbon, Portugal); Instituto Superior T\u00e9cnico, Universidade de Lisboa (Lisbon, Portugal)"}]},{"given":"Maria-Joao","family":"Cardoso","sequence":"additional","affiliation":[{"name":"9Breast Unit, Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal); Faculdade de Medicina da Universidade de Lisboa (Lisbon, Portugal),"}]}],"member":"1086","container-title":["Cancer Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/aacrjournals.org\/cancerres\/article\/84\/9_Supplement\/PO3-19-11\/744794\/Abstract-PO3-19-11-CINDERELLA-Clinical-Trial","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/aacrjournals.org\/cancerres\/article\/84\/9_Supplement\/PO3-19-11\/744794\/Abstract-PO3-19-11-CINDERELLA-Clinical-Trial","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T06:47:03Z","timestamp":1714632423000},"score":1,"resource":{"primary":{"URL":"https:\/\/aacrjournals.org\/cancerres\/article\/84\/9_Supplement\/PO3-19-11\/744794\/Abstract-PO3-19-11-CINDERELLA-Clinical-Trial"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,2]]},"references-count":0,"journal-issue":{"issue":"9_Supplement","published-print":{"date-parts":[[2024,5,2]]}},"URL":"https:\/\/doi.org\/10.1158\/1538-7445.sabcs23-po3-19-11","relation":{},"ISSN":["1538-7445"],"issn-type":[{"value":"1538-7445","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,2]]}}}