Arm Swelling Occurence in Breast Cancer Patients With Nodal Radiotherapy: Impact of Informing Them of AI-predicted Risk

Impact of communicating the risk prediction for arm lymphedema on the choice of radiotherapy modality, fractionation, technique and nodal levels irradiated

Radiotherapy modalities: technique used, fractionation (use of moderately and ultra-hypofractionated), and lymph node levels treated will be compared in both arms

Time frame: Up to 3 months from randomization.

Acute and late toxicity during the study

The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders

Time frame: Throughout study completion, up to 2 years.

Range of shoulder motion (ROM) of the arms

The range of shoulder motion (ROM) of the arms (flexion/abduction) will be reported by the radiation oncologist according to a circular scale

Time frame: Throughout study completion, up to 2 years.

Breast cosmetic result

The global cosmetic result after breast conservation surgery will be based on Harris 4-point scale (4-point Likert scale: Excellent, Good, Fair, Poor)

Time frame: Throughout study completion, up to 2 years.

Performance of the arm lymphedema risk prediction model

The performance will be assessed by the discrimination and the calibration of the model in the control arm. The discrimination refers to how well the model differentiates patients at higher risk of having an event from those at lower risk. For assessing discrimination at fixed time point of occurrence of event of interest, the area under the receiver operating characteristic curve (AUC) will be calculated. The calibration expresses the agreement between the observed and predicted outcome values. To assess whether the observed event rate equals the predicted risk in different groups of predicted risks, calibration curve will be created.

Time frame: At 2 years

Quality of life questionnaire - Core 30 (QLQ-C30)

Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level

Time frame: At baseline, end of treatment visit, 1 year and 2 years

Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)

This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms

Time frame: At baseline, end of treatment visit, 1 year and 2 years

The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire

Developed by the EuroQol group, the self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS) The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 5 levels (1 = "no problems", 2 = "slight problems", 3 = "moderate problems", 4 = "severe problems", and 5 = "extreme problems"). This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 0 (The best health you can image) to 100 (The worst health you can image). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement

Time frame: At baseline, end of treatment visit, 1 year and 2 years

Compliance with compression arm sleeve use

Compliance with the use of the compression arm sleeve will be measured by the frequency with which the patient wears it according to the patient

Time frame: At end of treatment visit, 3-month after starting radiotherapy, at 1 year and 2 years

Loco-regional relapse-free survival (RFS)

Locoregional recurrence-free survival is the time from randomisation until locoregional recurrence (as the first recurrence event) or death

Time frame: From randomization until the first invasive ipsilateral breast tumor recurrence, loco regional invasive recurrence, ipsilateral DCIS or death from any cause up to 2 years

Distant disease-free survival (DDFS)

Distant disease-free survival is defined as the time from randomization until the recurrence of disease (first, occurrence of metastasis or distant relapse) or death from any cause using DATECAN definitions of breast-cancer related endpoints

Time frame: From randomization until the recurrence of disease or death from any cause up to 2 years

Overall survival (OS)

The overall survival is the length of time from randomization that patients enrolled in the study are still alive

Time frame: From randomization to death from any cause, up to 2 years