Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment. (CINDERELLA)
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ClinicalTrials.gov Identifier: NCT05196269 |
Recruitment Status :
Recruiting
First Posted : January 19, 2022
Last Update Posted : March 21, 2024
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Device: Artificial Intelligence and Digital Health Arm | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1030 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective randomized open trial with parallel groups |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | August 8, 2023 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
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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.
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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 |
Control Comparator
The standard approach of proposing patients for locoregional treatment with or without printed or digital materials and hypothetic visualization of results.
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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 |
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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. |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05196269
Contact: Maria-Joao Cardoso, MD, PhD | +351 966484826 | maria.joao.cardoso@fundacaochampalimaud.pt |
Germany | |
Universitätsklinikum Heidelberg | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: Martina Manns +49 6221 568438 Martina.Manns@med.uni-heidelberg.de | |
Principal Investigator: Joerg Heil, MD, PhD | |
Israel | |
Sheba Medical Center | Recruiting |
Ramat Gan, Israel, 52621 | |
Contact: Michaela Ofir michaela.smiloviciofir@sheba.health.gov.il | |
Principal Investigator: Orit Kaidar-Person, MD, PhD | |
Sub-Investigator: Dov Zippel | |
Sub-Investigator: Nama Hermann | |
Sub-Investigator: Josef Haik | |
Italy | |
IRCCS Ospedale San Raffaele | Recruiting |
Milano, Italy, 20132 | |
Contact: Thierry Touvier touvier.thierry@hsr.it | |
Principal Investigator: Oreste Gentilini, MD, PhD | |
Sub-Investigator: Rosa di Mico | |
Poland | |
Copernicus Mamma Centrum, Wojewodzkie Centrum Onkologii, Copernicus Podmiot Leczniczy | Recruiting |
Gdańsk, Pomeranian, Poland, 80-210 | |
Contact: Pawel Kabata, MD, PhD pawel.kabata@iplpk.onmicrosoft.com | |
Principal Investigator: Pawel Kabata, MD, PhD | |
Gdański Uniwersytet Medyczny | Recruiting |
Gdańsk, Pomeranian, Poland, 80-210 | |
Contact: Mateusz Kirjak m.kirjak@gumed.edu.pl | |
Principal Investigator: Maciej Bobowicz, MD, PhD | |
Sub-Investigator: Elzbieta Senkus-Konefka, MD, PhD | |
Portugal | |
Champalimaud Research and Clinical Centre, Champalimaud Foundation | Recruiting |
Lisboa, Portugal, 1400-038 | |
Contact: Maria-Joao Cardoso, MD, PhD maria.joao.cardoso@fundacaochampalimaud.pt | |
Contact: Eduard-Alexandru Bonci, MD, PhD eduard.bonci@research.fchampalimaud.org | |
Principal Investigator: Maria-Joao Cardoso, MD, PhD | |
Sub-Investigator: Carlos Mavioso, MD | |
Sub-Investigator: Pedro Gouveia, MD, PhD | |
Sub-Investigator: David Pinto, MD | |
Sub-Investigator: Rogelio Andrés-Luna, MD |
Principal Investigator: | Maria-Joao Cardoso, PhD | Champalimaud Foundation |
Responsible Party: | Maria-Joao Cardoso, Head Breast Surgeon - MD, PhD, Fundacao Champalimaud |
ClinicalTrials.gov Identifier: | NCT05196269 |
Other Study ID Numbers: |
CINDERELLA |
First Posted: | January 19, 2022 Key Record Dates |
Last Update Posted: | March 21, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast cancer Surgery Radiation Artificial Intelligence Outcomes |
Aesthetics Expectations Satisfaction Quality of life Digital Platform |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |