Breast Cancer Radiation Therapy Unit, Sheba Medical Center, Ramat Gan, Israel.
School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
PLoS One. 2023 Aug 3;18(8):e0289365. doi: 10.1371/journal.pone.0289365. eCollection 2023.
Breast cancer therapy improved significantly, allowing for different surgical approaches for the same disease stage, therefore offering patients different aesthetic outcomes with similar locoregional control. The purpose of the CINDERELLA trial is to evaluate an artificial-intelligence (AI) cloud-based platform (CINDERELLA platform) vs the standard approach for patient education prior to therapy.
A prospective randomized international multicentre trial comparing two methods for patient education prior to therapy. After institutional ethics approval and a written informed consent, patients planned for locoregional treatment will be randomized to the intervention (CINDERELLA platform) or controls. The patients in the intervention arm will use the newly designed web-application (CINDERELLA platform, CINDERELLA APProach) to access the information related to surgery and/or radiotherapy. Using an AI system, the platform will provide the patient with a picture of her own aesthetic outcome resulting from the surgical procedure she chooses, and an objective evaluation of this aesthetic outcome (e.g., good/fair). The control group will have access to the standard approach. The primary objectives of the trial will be i) to examine the differences between the treatment arms with regards to patients' pre-treatment expectations and the final aesthetic outcomes and ii) in the experimental arm only, the agreement of the pre-treatment AI-evaluation (output) and patient's post-therapy self-evaluation.
The project aims to develop an easy-to-use cost-effective AI-powered tool that improves shared decision-making processes. We assume that the CINDERELLA APProach will lead to higher satisfaction, better psychosocial status, and wellbeing of breast cancer patients, and reduce the need for additional surgeries to improve aesthetic outcome.
乳腺癌治疗有了显著的改善，使得相同疾病阶段的患者可以采用不同的手术方法，从而为患者提供不同的美学效果和相似的局部区域控制效果。CINDERELLA 试验的目的是评估一种基于人工智能（AI）的云平台（CINDERELLA 平台）与治疗前患者教育的标准方法相比的效果。
这是一项前瞻性随机国际多中心试验，比较了治疗前患者教育的两种方法。在机构伦理审查和书面知情同意后，计划接受局部区域治疗的患者将被随机分配至干预组（CINDERELLA 平台）或对照组。干预组的患者将使用新设计的网络应用程序（CINDERELLA 平台，CINDERELLA APProach）访问与手术和/或放疗相关的信息。该平台将使用 AI 系统为患者提供她所选择的手术程序的美学效果图片，并对这种美学效果进行客观评估（例如，好/一般）。对照组将使用标准方法。试验的主要目的是 i）比较治疗组在患者治疗前的预期和最终美学效果方面的差异，以及 ii）仅在实验组中，比较治疗前 AI 评估（输出）和患者治疗后自我评估的一致性。
该项目旨在开发一种易于使用且具有成本效益的 AI 驱动工具，以改善共同决策过程。我们假设 CINDERELLA APProach 将提高乳腺癌患者的满意度、更好的社会心理状态和幸福感，并减少改善美学效果所需的额外手术。
