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The Breast Edema Questionnaire (BrEQ) is a validated Dutch patient-reported outcome measure designed to assess the impact of breast oedema. Part 1 of the BrEQ evaluates eight symptoms: pain, heaviness, swelling, tensed skin, redness, pitting sign, enlarged skin pores, and hardness. Each symptom is scored on an 11-point Likert scale ranging from 0 ("not at all") to 10 ("very severe"), resulting in a total symptom score ranging from 0 to 80. Higher scores indicate greater severity of breast oedema symptoms. A total score of ≥9 has been identified as the optimal cut-off point to discriminate between patients with and without breast oedema. The primary comparison will assess group differences in BrEQ score after one month of treatment.
A self-developed diary for assessing the feasibility of kinesio tape application. This diary tracks when the tape is applied, how long it is worn, and evaluates how feasible it is for the patient to apply it independently. Additionally, it monitors costs to determine the cost-effectiveness of kinesio taping.
The responsiveness of the BrEQ analysed via comparison with the Global Perceived Effect (GPE) scale and ROC analysis. Additional analyses include Cohen's d and SRM.
Pressure (in mmHg) exerted by different commercially available compression bras will be measured using the PicoPress device.
The LymphScanner is a non-invasive diagnostic device used to objectively measure percentage water content (PWC) in subcutaneous tissue. It uses tissue dielectric constant (TDC) technology to assess local water levels. Measurements are taken at standardised points on the breast and trunk from which ratios are calculated to monitor evolution. Higher PWC values indicate higher levels of local tissue water. Changes over time reflect progression or reduction of oedema.
Pain intensity is assessed with the Visual Analogue Scale (VAS), a validated 10-cm horizontal scale on which participants indicate their perceived pain level. The scores range from 0 (no pain) to 10 (worst pain). The outcome is the change in VAS scores over time. A decrease in score indicates a reduction in pain severity.
The EORTC-QLQ-BR23 is a breast cancer-specific quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC). It assesses the quality of life in breast cancer patients, focusing on aspects like body image, sexual functioning, treatment side-effects and emotional well-being. Scores for each domain are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate more severe symptoms.
The EQ-5D-5L is a standardised tool for measuring health-related quality of life in breast cancer patients. It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels of severity. The questionnaire also includes a visual analogue scale, where patients rate their overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The outcome is the change from baseline in both the index-based utility score and VAS score.
A self-developed diary for standard care, which is a comprehensive tool designed to track various aspects of standard care during the intervention period and follow-up. Its primary purpose is to provide a detailed record of essential care practices, ensuring participants follow the recommended protocols and enabling investigators to monitor progress accurately. The diary will cover several key areas: skin care, compression therapy, exercises, physiotherapy and a few additional questions.
The BrEQ is a validated patient-reported measure of breast oedema symptoms. Part 1 includes 8 items scored from 0 (not at all) to 10 (very severe), with a total score ranging from 0 to 80. Higher scores indicate worse symptoms. A score of ≥9 indicates presence of breast oedema.
Patient-reported comfort is assessed using an adjusted version of the International Compression Club Compression Questionnaire (ICC-CQ), patient version. The questionnaire includes items about putting on and taking off the compression garment, perceived comfort, and any side effects experienced. It consists of yes/no questions and items rated on an 11-point Likert scale (0-10). Higher scores indicate greater ease in putting on and taking off the garment, greater comfort, and more side effects, respectively. No total or summary scores are calculated.