Abstract 108TiP
Background
Breast cancer management often requires a delicate balance between effective treatments and preserving patient’s quality of life. Standardised methods to inform patients about different locoregional therapies and assess their aesthetic outcomes expectations are currently lacking. The CINDERELLA clinical trial addresses this gap by introducing an innovative artificial intelligence (AI)-driven tool designed for shared decision-making in breast cancer treatment. The study is expected to demonstrate the potential of AI in enhancing patient satisfaction and quality of life while maintaining high standards of care, leading us into the new era of breast cancer management, where technology and medical expertise converge to optimise aesthetic outcomes.
Trial design
This international randomised controlled trial uses the CINDERELLA APP. The APP showcases educational content and potential aesthetic outcomes of various locoregional treatments, aiding informed decision-making. The trial compares this AI-enhanced approach with standard informed consent processes. CANKADO is the core platform for physicians to manage patient APP content and gather data, ensuring privacy, data protection, and adherence to ethical AI principles. Eligibility criteria: non-metastaticbreast cancer patients eligible for either breast-conserving surgery or mastectomy with immediate reconstruction. Specific aims: the trial primarily aims to assess how well patients’ expectations align with actual aesthetic outcomes 12 months post-treatment. The correlation between AI tool predictions and patient self-evaluations, alongside examining health-related quality of life and resource utilisation are also being evaluated. Statistical methods: assessment of agreement levels between expectations and outcomes will utilise the Wilcoxon signed-rank test, with additional statistical tests and bootstrap techniques for inter-arm comparisons. Present accrual: recruitment began in August 2023, aiming to enrol at least 515 patients/arm across several countries. As of January 26, 2024, clinical study sites have successfully randomised 177 patients.
Clinical trial identification
NCT05196269.
Legal entity responsible for the study
Champalimaud Research and Clinical Centre, Champalimaud Foundation (Lisbon, Portugal).
Funding
European Union - HORIZON-HLTH-2021-DISEASE-04-04, Agreement No. 101057389.
Disclosure
O. Ciani: Financial Interests, Personal, Advisory Board: MSD. R. Di Micco: Financial Interests, Personal, Research Grant: Fondazione AIRC per la Ricerca sul Cancro. O.D. Gentilini: Financial Interests, Personal, Other, Honoraria: MSD, AstraZeneca, BD, Bayer, Eli Lilly; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Speaker’s Bureau: MSD, AstraZeneca, BD, Bayer, Eli Lilly; Financial Interests, Personal, Expert Testimony: MSD, AstraZeneca, BD; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: MSD, AstraZeneca. P. Kabata: Financial Interests, Personal, Full or part-time Employment: Copernicus Podmiot Leczniczy Sp. z o.o.; Financial Interests, Personal, Leadership Role: WJS sp z o.o; Financial Interests, Personal, Stocks/Shares: WJS sp. z o.o.; Financial Interests, Personal, Other, Honoraria: Roche, Novartis; Financial Interests, Personal, Advisory Role: Nutricia; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Nutricia. L. Borsoi: Financial Interests, Personal, Research Grant: Sanofi, AstraZeneca, Boehringer Ingelheim, Echolight, BD. T. Schinköthe: Financial Interests, Personal, Leadership Role: Cankado; Financial Interests, Personal, Ownership Interest: Cankado. M.J. Cardoso: Financial Interests, Personal, Invited Speaker: MSD, Lilly, Novartis; Financial Interests, Personal, Other, travel, accommodations, expenses: Roche; Non-Financial Interests, Personal, Member: European School of Oncology (ESO); Non-Financial Interests, Personal, Member of Board of Directors: European Society of Breast Cancer Specialists (EUSOMA); Non-Financial Interests, Personal, Leadership Role: Mama Help; Non-Financial Interests, Personal, Project Lead: Institute for Systems and Computer Engineering, Technology and Science (INESC TEC). All other authors have declared no conflicts of interest.