Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment. (CINDERELLA)

• ClinicalTrials.gov Identifier: NCT05196269
• Recruitment Status: Recruiting
• First Posted: January 19, 2022
• Last Update Posted: March 21, 2024
• 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
• Information provided by (Responsible Party): Maria-Joao Cardoso, Fundacao Champalimaud

Tracking Information

• First Submitted Date: October 26, 2021
• First Posted Date: January 19, 2022
• Last Update Posted Date: March 21, 2024
• Actual Study Start Date: August 8, 2023
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 16, 2023)

• 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.
• 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.

Original Primary Outcome Measures (submitted: January 18, 2022)

• 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.
• 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.

Current Secondary Outcome Measures (submitted: August 16, 2023)

• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: January 18, 2022)

• 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 .
• 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
• Patient's satisfaction with their professional life evaluated in both the intervention and control arm with the EORTC QLQ C-30 (Quality of Life of Cancer Patients) and BR23 (Breast 23 items ) [ Time Frame: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done) ]
  How results impact in patients professional life measured through the EORTC QLQ C-30 and BR23 that is a companion questionnaire for the C-30 specific to breast with 23 items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a high / healthy level of functioning.
• Patient's sexual life satisfaction evaluated in both the intervention and control arm with with the EORTC QLQ C-30 (Quality of Life of Cancer Patients) and BR23 (Breast 23 items ) [ Time Frame: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done) ]
  How results impact in patients professional life measured through the EORTC QLQ C-30 and BR23 that is a companion questionnaire for the C-30 specific to breast with 23 items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a high / healthy level of functioning.
• Patient's general health-related quality of life evaluated in both the intervention and control arm with the EQ-5D-5L (Euro-Quality Group 5 dimensions /5 levels and EORTC QLQ C-30 questionnaires. [ 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 and EORTC QLQ C-30 questionnaires. Both score from 0 -100. A high scale score represents a high / healthy level of functioning.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.
• Official Title: 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
• 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective randomized open trial with parallel groups

Masking: None (Open Label)
Primary Purpose: Other

• Condition: Breast Cancer

Intervention

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.

Other Name: Artificial Intelligence and cloud-based digital health platform

Study Arms

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

Publications *

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• Ong WL, Schouwenburg MG, van Bommel ACM, Stowell C, Allison KH, Benn KE, Browne JP, Cooter RD, Delaney GP, Duhoux FP, Ganz PA, Hancock P, Jagsi R, Knaul FM, Knip AM, Koppert LB, Kuerer HM, McLaughin S, Mureau MAM, Partridge AH, Reid DP, Sheeran L, Smith TJ, Stoutjesdijk MJ, Vrancken Peeters MJTFD, Wengstrom Y, Yip CH, Saunders C. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017 May 1;3(5):677-685. doi: 10.1001/jamaoncol.2016.4851.
• Ciani O, Federici CB. Value Lies in the Eye of the Patients: The Why, What, and How of Patient-reported Outcomes Measures. Clin Ther. 2020 Jan;42(1):25-33. doi: 10.1016/j.clinthera.2019.11.016. Epub 2020 Jan 10.
• Fitzal F, Krois W, Trischler H, Wutzel L, Riedl O, Kuhbelbock U, Wintersteiner B, Cardoso MJ, Dubsky P, Gnant M, Jakesz R, Wild T. The use of a breast symmetry index for objective evaluation of breast cosmesis. Breast. 2007 Aug;16(4):429-35. doi: 10.1016/j.breast.2007.01.013. Epub 2007 Mar 26.
• Cardoso MJ, Cardoso J, Amaral N, Azevedo I, Barreau L, Bernardo M, Christie D, Costa S, Fitzal F, Fougo JL, Johansen J, Macmillan D, Mano MP, Regolo L, Rosa J, Teixeira L, Vrieling C. Turning subjective into objective: the BCCT.core software for evaluation of cosmetic results in breast cancer conservative treatment. Breast. 2007 Oct;16(5):456-61. doi: 10.1016/j.breast.2007.05.002. Epub 2007 Jul 2.
• Cardoso JS, Cardoso MJ. Towards an intelligent medical system for the aesthetic evaluation of breast cancer conservative treatment. Artif Intell Med. 2007 Jun;40(2):115-26. doi: 10.1016/j.artmed.2007.02.007. Epub 2007 Apr 8.
• Heil J, Dahlkamp J, Golatta M, Rom J, Domschke C, Rauch G, Cardoso MJ, Sohn C. Aesthetics in breast conserving therapy: do objectively measured results match patients' evaluations? Ann Surg Oncol. 2011 Jan;18(1):134-8. doi: 10.1245/s10434-010-1252-4. Epub 2010 Aug 10.
• Cardoso MJ, Cardoso JS, Oliveira HP, Gouveia P. The breast cancer conservative treatment. Cosmetic results - BCCT.core - Software for objective assessment of esthetic outcome in breast cancer conservative treatment: A narrative review. Comput Methods Programs Biomed. 2016 Apr;126:154-9. doi: 10.1016/j.cmpb.2015.11.010. Epub 2015 Dec 9.
• Cardoso JS, Silva W, Cardoso MJ. Evolution, current challenges, and future possibilities in the objective assessment of aesthetic outcome of breast cancer locoregional treatment. Breast. 2020 Feb;49:123-130. doi: 10.1016/j.breast.2019.11.006. Epub 2019 Nov 21.
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• Brunet J, Price J. A scoping review of measures used to assess body image in women with breast cancer. Psychooncology. 2021 May;30(5):669-680. doi: 10.1002/pon.5619. Epub 2021 Jan 21.
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• Preuss J, Lester L, Saunders C. BCCT.core - can a computer program be used for the assessment of aesthetic outcome after breast reconstructive surgery? Breast. 2012 Aug;21(4):597-600. doi: 10.1016/j.breast.2012.05.012. Epub 2012 Jun 17.
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Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 18, 2022): 1030
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

Gender Eligibility Description

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.

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Maria-Joao Cardoso, MD, PhD; +351 966484826; maria.joao.cardoso@fundacaochampalimaud.pt

• Listed Location Countries: Germany, Israel, Italy, Poland, Portugal

Administrative Information

• NCT Number: NCT05196269
• Other Study ID Numbers: CINDERELLA
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Maria-Joao Cardoso, Fundacao Champalimaud
• Original Responsible Party: Fundacao Champalimaud
• Current Study Sponsor: Fundacao Champalimaud
• Original Study Sponsor: Same as current

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

Investigators

• Principal Investigator: Maria-Joao Cardoso, PhD; Champalimaud Foundation

• PRS Account: Fundacao Champalimaud
• Verification Date: March 2024