Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.

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.

Conditions

• Breast Cancer

Interventions

DEVICE

Artificial Intelligence and Digital Health Arm

A previous large database repository of images having thousands of pre and postoperative photographs of breast cancer patients proposed for locoregional treatment with clinical and biometric data will be matched using artificial intelligence within the CANKADO platform. Patients proposed for breast cancer locoregional treatment will have access to the software installed, and they will have access to all the information about the type of treatment they will receive. All the questions and questionnaires will be filled out online, and they can visualise the expected outcome from excellent to poor.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal)

  collaborator UNKNOWN

• Cankado GmbH

  collaborator INDUSTRY

• FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal)

  collaborator UNKNOWN

• Bocconi University

  collaborator OTHER

• Fundacao Champalimaud

  lead OTHER

Principal Investigators

• Maria-Joao Cardoso, MD, PhD · Champalimaud Foundation

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-08

Primary Completion

2026-04-30

Completion

2026-12-31

Countries

• Germany
• Israel
• Italy
• Poland
• Portugal

Study Locations