Comparing Decision on Match of Expectations and Aesthetics Using a Conventional Versus a Cloud-based Healthcare Platform Approach in Breast Cancer Patients Proposed for Locoregional Treatment: A Prospective Randomized Trial
Trial ID: NCT05196269
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-08-08
Completion date: 2026-12
Sponsor: Fundacao Champalimaud
Collaborators: European Commission; INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal); Cankado GmbH; FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal); Bocconi University
Conditions: Breast Cancer
Interventions: Artificial Intelligence and Digital Health Arm
Locations: Universitätsklinikum Heidelberg; Sheba Medical Center; IRCCS Ospedale San Raffaele; Copernicus Mamma Centrum, Wojewodzkie Centrum Onkologii, Copernicus Podmiot Leczniczy; Gdański Uniwersytet Medyczny; Champalimaud Research and Clinical Centre, Champalimaud Foundation
Countries: Germany; Israel; Italy; Poland; Poland; Portugal
Enrollment: 1030
Age range: 18 Years - None
Sex: ALL

Summary:
Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Different surgical techniques can be offered to the patient, each leading to completely different aesthetic outcomes. Moreover, the aesthetic outcome could be completely different for patients undergoing the same surgery based on individual patient factors (e.g., age, body habitus). In the CINDERELLA trial, the investigators will be using the (Breast Locoregional (BreLO) AI system (an artificial intelligence-based tool for the classification of aesthetic outcomes and matching data and photographs) integrated into CANKADO (a cloud-based healthcare platform) to create an easy-to-use application that can be used on any electronic device, to simulate visually to the patient the aesthetic outcome of a certain surgery or radiation treatment. In the CINDERELLA trial, the investigators plan to compare whether the application helped fulfil the expectations and lead to a better quality of life compared with the classical approach. In the classical approach (control arm), doctors usually propose a locoregional treatment and explain theoretically how the result will be. Nurses help by explaining further details about the surgery and possible outcomes. In most centres, no photographic evaluation is done, and expectations are not measured. The CINDERELLA trial will help overcome miscommunication and potential boundaries in the patient's or physician's understanding of the potential outcomes of locoregional breast cancer treatment.

Eligibility criteria:
Inclusion :

* More than 18 years old
* Written informed consent
* Primary breast cancer in situ or invasive without evidence of systemic disease - non Stage IV or locally advanced non-operable breast cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Uni or Bilateral surgery even if prophylactic in one side
* Capacity to use a web-based app autonomously or with home-based support

Exclusion:

* Mastectomy without reconstruction
* Pregnancy or lactation
* Previous radiation to breast/chest (e.g., lymphoma)
* Previous ipsilateral breast surgery due to malignant disease.
* Other neoplasm in the last 5 years (excluding basal cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix)
* Severe skin disease that will contra-indicate the use of radiotherapy
* Prophylactic surgery

Outcomes:
Agreement between patients expectations before and after treatment in both the intervention and the control arm; Agreement about the aesthetic outcome between the objective evaluation and self- evaluation measured after treatment in both the intervention and the control arm