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JOURNAL ONKOLOGIE – STUDIE
CINDERELLA

Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.

Rekrutierend

NCT-Nummer:
NCT05196269

Studienbeginn:
August 2023

Letztes Update:
21.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Fundacao Champalimaud

Collaborator:
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,

Studienleiter

Maria-Joao Cardoso, PhD
Principal Investigator
Champalimaud Foundation

Kontakt

Maria-Joao Cardoso, MD, PhD
Kontakt:
Phone: +351 966484826
E-Mail: maria.joao.cardoso@fundacaochampalimaud.pt» Kontaktdaten anzeigen

Studienlocations
(3 von 6)

Universitätsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Martina Manns
Phone: +49 6221 568438
E-Mail: Martina.Manns@med.uni-heidelberg.de» Ansprechpartner anzeigen
Copernicus Mamma Centrum, Wojewodzkie Centrum Onkologii, Copernicus Podmiot Leczniczy
80-210 Gdańsk
PolandRekrutierend» Google-Maps
Ansprechpartner:
Pawel Kabata, MD, PhD
E-Mail: pawel.kabata@iplpk.onmicrosoft.com» Ansprechpartner anzeigen
Champalimaud Research and Clinical Centre, Champalimaud Foundation
1400-038 Lisboa
PortugalRekrutierend» Google-Maps
Ansprechpartner:
Maria-Joao Cardoso, MD, PhD
E-Mail: maria.joao.cardoso@fundacaochampalimaud.pt

Eduard-Alexandru Bonci, MD, PhD
E-Mail: eduard.bonci@research.fchampalimaud.org» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

The CINDERELLA clinical trial will be an open, prospective randomized trial that Champalimaud

Foundation will coordinate. Five clinical centres agreed to participate in the trial. The

trial will be designed and reported according to the latest SPIRIT-AI and CONSORT-AI

guidelines.

The randomization will be made by adopting a dynamical approach following the Minimization

Method. Assignment of the recruited patients to the study arms will take into account the

stratification of the participants (younger and older than 50 / breast-conserving or

mastectomy / mastectomy with or without radiotherapy), aiming to reduce bias and confounding

by assuring the balance of the group.

After being proposed to the trial and checked for all the eligibility criteria, patients will

be given the complete patient information before signing the informed consent.

For the five centres, a minimum of 515 patients should be enrolled in each arm of the study.

After randomization, the patient will either follow:

1. - The intervention arm with the CINDERELLA APProach with the introduction and access to

CANKADO with the BreLO AI system. The Expectations Questionnaire, Healthcare

Professionals Multidimensional Evaluation Questionnaire and standard patient-reported

outcomes measures (PROMs) (EQ-5D-5L and BREAST Q ICHOM) will be filed electronically.

Standard photographic capture will be taken at this point. After the photographic

capture, the BreLO-AI will match the patient biometrics and images with the more

identical case existing in the BreLO repository and already classified by the BCCT.core

into excellent, good, fair and poor. The new patient can then visualize the results. In

case of doubts, queries will be answered through the app or, if needed, by phone call or

booking another appointment. Questionnaires and Photographs will be repeated after wound

healing is complete, six months and one year after the end of treatment (surgery or

radiotherapy if radiotherapy was done).

2. - The control arm with the Conventional approach with a theoretical explanation by the

doctor/nurse of the proposed locoregional treatment and possible outcomes. The

Expectations Questionnaire, Healthcare Professionals Multidimensional Evaluation

Questionnaire and standard PROMs (EQ-5D-5L and BREAST Q ICHOM) will be filed

electronically. Standard photographic capture will be taken at this point. In case of

doubts, the patient will book another appointment with the doctor/nurse, as usually done

in routine practice. Questionnaires and Photographs will be repeated after healing is

complete, six months and one year after the end of treatment (surgery or radiotherapy if

radiotherapy was done).

Digital Photography (same protocol for all participating centres) - a similar protocol for

image capture will exist for all centres. The standalone photography with an automatic robot

will be progressively implemented (www.photorobot.com).

DATA COLLECTION

PATIENT-RELATED FACTORS

- Date of birth, Weight / Height / BMI, Thoracic perimeter, Bra size and cup

- Education degree, Profession, Hobbies

- Marital status, Pregnancies and offspring

- Breast-feeding, Menopausal status

- Smoking

- Connective tissue diseases

- Confirmed Pathogenic Germline Variant

TUMOUR-RELATED FACTORS

- Unilateral (unifocal, multifocal, multicentric) Bilateral

- Histological type according to World Health Organization (WHO) classification (e.g.,

invasive ductal carcinoma, lobular carcinoma) (size in mm) staging ER, PR, Her2, Ki67,

cTNM - pTNM / ypTNM

TREATMENT-RELATED FACTORS

*Type of Surgery/ Type of Reconstruction: (data collection regarding surgery should also

include acellular dermal matrice (ADM) if used - type and placement) TYPE OF SURGERY: C1 -

Conservative surgery - unilateral or bilateral, C2 - Conservative surgery with bilateral

reduction (uni or bilateral), C3 - Conservative surgery with LD or LICAP/TDAP, C4 -

Conservative surgery with bilateral breast augmentation, M1 - Mastectomy with unilateral

reconstruction with implant, M2 - Mastectomy with unilateral reconstruction with autologous

flap, M3 - Mastectomy with bilateral reconstruction with implants, M4 - Mastectomy with

bilateral reconstruction with autologous flaps, M5 - Mastectomy with unilateral

reconstruction with implant and contralateral symmetrisation with implant (augmentation), M6

- Mastectomy with unilateral reconstruction with implant and contralateral symmetrisation

with reduction, M7 - Mastectomy with unilateral reconstruction with autologous flap and

contralateral symmetrisation with reduction, M8 - Mastectomy with unilateral reconstruction

with autologous flap and contralateral symmetrisation with implant (augmentation).

STATISTICAL ANALYSIS

An extensive descriptive analysis will be performed to characterize the groups in detail and

the outcomes of the study at baseline as well as in the following points of data collection.

Concerning the primary objectives, models of the class of generalized linear mixed models (in

particular, multinomial regression models for ordinal data) will be estimated to evaluate the

effect of the training and the women's characteristics on their evaluation of the aesthetic

results of the surgery at each time and along time through longitudinal analysis. The

Wilcoxon signed rank test for pairs will also be used to evaluate the effect of training on

the level of agreement of the expectations and the final result. Weighted Cohen's k will be

calculated for both groups (train and control) and compared using a statistical test and/or

bootstrap techniques to assess the improvement in the ability to classify the aesthetic

result of their surgery provided by training. A measure of similarity between self-evaluation

and the BCCT.core will be computed for each participant, and a beta regression model will be

estimated to assess the effect of training, controlling variables that can play as

confounders, such as women's and disease characteristics at each time point and in a

longitudinal perspective. Concerning the secondary objectives, the patient-reported outcome

measures administered will be scored according to the official guidelines provided by the

developers of the instruments. Besides the descriptive statistics, the outcomes will be

compared between groups using adequate statistical tests. Again, models of the class of the

general linear mixed models will be used.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Agreement between patients expectations before and after treatment in both the intervention and the control arm (Time Frame - 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)):
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.

2. Agreement about the aesthetic outcome between the objective evaluation and self- evaluation measured after treatment in both the intervention and the control arm (Time Frame - 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)):
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.

Secondary outcome:

1. Patient's body image satisfaction after surgery measured through the BREAST-Q - International Consortium for Health Outcomes Measurement (ICHOM) questionnaire (Time Frame - 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)):
Body image perception and satisfaction using the BREAST-Q ICHOM questionnaire. The scale scores from 0 lowest to 100 highest (body image satisfaction) in both the intervention and the control arm.

2. 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 (Time Frame - 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done):
Resource consumption (cost per patient evaluated by the amount of appointments between the surgical proposal by the surgeon and the end of the trial) in both the intervention and control arm.

3. Patient's general health-related quality of life evaluated in both the intervention and control arm with the EQ-5D-5L questionnaire (Time Frame - 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)):
How results impact in patients general quality of life evaluated in both the intervention and control arm with the EQ-5D-5L questionnaire. The scale scores from 0 lowest to 100 highest. A high scale score represents a high/healthy level of functioning.

Studien-Arme

  • Experimental: Artificial Intelligence and Digital Health Arm
    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.
  • Other: Control Comparator
    The standard approach of proposing patients for locoregional treatment with or without printed or digital materials and hypothetic visualization of results.

Geprüfte Regime

  • Artificial Intelligence and Digital Health Arm (Artificial Intelligence and cloud-based digital health platform):
    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.

Quelle: ClinicalTrials.gov


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