Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.

NCT05196269 | Active Not Recruiting DMC

• 1 other identifier: CINDERELLA
• Study Type: interventional
• Target: 1,030
• Locations: 5 countries
• Sites: 6

Brief 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

Keywords

Breast cancer; Surgery; Radiation; Artificial Intelligence; Outcomes; Aesthetics; Expectations; Satisfaction; Quality of life; Digital Platform

Outcome Measures

Primary Outcomes (2)

• Agreement between patients expectations before and after treatment in both the intervention and the control arm

  Agreement between patient's expectations about the aesthetic outcome measured before and after treatment, evaluated at 12 months after treatment (Cohen's Kappa and weighted Kappa Statistics) both the intervention and the control arm.

  12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)

• Agreement about the aesthetic outcome between the objective evaluation and self- evaluation measured after treatment in both the intervention and the control arm

  Agreement about the aesthetic outcome between the AI evaluation tool (BCT.core software) and self- evaluation after treatment (Cohen's Kappa and weighted Kappa Statistics) in both the intervention and the control arm.

  12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)

Secondary Outcomes (3)

• Patient's body image satisfaction after surgery measured through the BREAST-Q - International Consortium for Health Outcomes Measurement (ICHOM) questionnaire

  12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)

• Resource consumption a) time spent in hospital b) number of appointments c) duration until treatment d) out of pocket expenditure, additional care sought by patients

  12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done

• Patient's general health-related quality of life evaluated in both the intervention and control arm with the EQ-5D-5L questionnaire

  12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)

Study Arms (2)

Artificial Intelligence and Digital Health Arm

EXPERIMENTAL

Using an Artificial Intelligence approach integrated in a cloud-based healthcare platform CANKADO to give the patient complete information about the proposed type of locoregional treatment and access to photographs and data of patients with similar characteristics previously treated with the same technique. All interaction will be through the CANKADO Platform.

Device: Artificial Intelligence and Digital Health Arm

Control Comparator

OTHER

The standard approach of proposing patients for locoregional treatment with or without printed or digital materials and hypothetic visualization of results.

Device: Artificial Intelligence and Digital Health Arm

Interventions

Artificial Intelligence and Digital Health Arm DEVICE

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.

Also known as: Artificial Intelligence and cloud-based digital health platform

Artificial Intelligence and Digital Health Arm; Control Comparator

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The solution we aim to apply in clinical practice is non-sex/gender specific. However, the proposal focuses on breast cancer, where there will be a predominance of female participants. The incidence of breast cancer contrasts strikingly according to gender, with approximately 1% of all tumours occurring in males. Although breast conservation can also be offered to men, it is a rare practice, and most men are submitted to mastectomy without breast reconstruction. As a consequence, it will be very difficult to recruit male patients to the study and obtain data that will allow any conclusions taking into account that mastectomy without reconstruction is out of our scope, and as such will not be included in our trial.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacao Champalimaud: lead
• European Commission: collaborator
• INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal): collaborator
• Cankado GmbH: collaborator
• FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal): collaborator
• Bocconi University: collaborator

Study Sites (6)

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Copernicus Mamma Centrum, Wojewodzkie Centrum Onkologii, Copernicus Podmiot Leczniczy

Gdansk, Pomeranian, 80-210, Poland

Location

Gdański Uniwersytet Medyczny

Gdansk, Pomeranian, 80-210, Poland

Location

Champalimaud Research and Clinical Centre, Champalimaud Foundation

Lisbon, Lisbon District, 1400-038, Portugal

Location

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MeSH Terms

Conditions

Breast Neoplasms; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Maria-Joao Cardoso, MD, PhD

  Champalimaud Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Breast Surgeon - MD, PhD

Model Details: Prospective randomized open trial with parallel groups

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: January 19, 2022
• Study Start: August 8, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); IT (1); PT (1); DE (1); IL (1)