CINDERELLA trial–objectives.
non-Stage, systemic disease, skin disease, breasts, psychiatric disorder, basal cell carcinoma of the skin, neoplasm, primary breast cancer
SKIN DISEASE, SYSTEMIC DISEASE, BREAST CANCER, EVENT, NEOPLASM, CARCINOMA IN SITU, LYMPHOMA, MALIGNANT DISEASE
Stratification will be considered to balance potential confounding factors that might influence aesthetic outcomes, i.e., type of surgery (conservative, mastectomy), patient age (<50, 50+) and radiotherapy (yes, no) (see flowchart in Eligibility criteria include: Female aged 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); ECOG performance status 0 or 1; Uni or Bilateral breast surgery even if prophylactic in one side; Ability to use a web-based app autonomously or with home-based support. Exclusion criteria include: 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; previous breast prophylactic surgery; uncontrolled psychiatric disorder.After randomization the patient will either follow the investigational arm with the CINDERELLA APProach vs. a conventional approach (control arm). For both study arms, patient’s breasts will be photographed (without identifiers) prior to any intervention. The patients will fill in an expectations questionnaire, resource consumption survey and patient-reported outcome measures (PROMs): EQ-5D-5L, EORTC QLQ C-30 and EORTC BR-23/EORTC QLQ BR-45, Harris Scale, and BREAST Q ICHOM. Questionnaires and photographs will be repeated after healing is completed, six months and one year after the end of treatment (surgery or radiotherapy if radiotherapy was done). Data manager will evaluate that all collected data and questionnaires are completed properly at the time of submission by the centres, to reduce the possibility of missing information and non-compliance with the protocol.Investigational arm-only: prior to deciding on locoregional therapy the patient will be given access to the CINDERELLA platform. The platform will contain clinical information as mentioned above. The patient breasts will be photographed prior to therapy by the research team. The BreLO AI (version 1.0) will match the patient biometrics and images with a similar case existent in the BreLO repository and already classified by the BCCT.core (version 4.0) into excellent, good, fair and poor. The patient can then visualize the results presented as synthetized images of her own body. BreLO AI will include an automatic image quality assessment module; if the images of the patient are below a quality standard, the matching will fail with an error message for the user.All trial information will be fed into the platform to improve the AI-system for performing biomatching. To promote participant retention and complete follow-up, an intense training of nurses in each site as well as continuous proactive follow-up will be ensured. If participants discontinue or deviate from intervention, we will document that event but not obtain any special outcome data.