Aurora: a Human-centered Program for Breast Cancer Patients in Chile, Easing Neoadjuvant Chemotherapy's Effects

To assess the effectiveness of the Aurora human centered design product system therapeutic intervention program in enhancing the biopsychosocial effects of breast cancer in women undergoing neoadjuvant chemotherapy in the metropolitan region of Chile, quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire, the QLQ-BR23 (Quality of life questionnaire number 23 for breast cancer) is a module tailored to breast cancer patients, focusing on symptoms and issues relevant to this group.

The EORTC QLQ-BR23 uses a 4-point Likert scale, where 1 represents "Not at all" and 4 represents "Very much." The scores are then transformed to a scale of 0 to 100, where higher scores indicate a higher level of symptoms or problems, and lower scores indicate a lower level of symptoms or problems.

Assess the effectiveness of the Aurora human centered design product system therapeutic intervention program in enhancing the biopsychosocial effects of breast cancer measured by by patient´s perceptions through a in depth interview, among women undergoing neoadjuvant chemotherapy in the metropolitan region of Chile by assessing the intervention group at the end of the program. Interviews will be transcribed and textual qualitative data will be analyzed to find emergent topics.

Examine the role of the Aurora human centered design product system therapeutic intervention program in reducing the biological consequences of breast cancer measured by lipid profile in plasma LDL, HDL, and RBCm fatty acids, among women undergoing neoadjuvant chemotherapy in the Metropolitan Region of Chile by comparing the intervention and control groups at baseline and at the end of the program.

The Two-Minute Walk Test is a simple performance-based test used to measure an individual's walking ability and functional capacity. In this test, the participant marches in place for two minutes, lifting their knees to a height midway between the patella (kneecap) and the iliac crest (hip bone). The number of times the right knee reaches this height is counted and recorded as the score. The variable measured is the number of repetitions completed within the 2-minutes timeframe, it is a quantitative discrete variable.

This volume test is a method used to measure arm volume, which is an important indicator for detecting and monitoring lymphedema, a common complication after breast cancer treatment. The test involves taking circumferential measurements of the arm at 6 specific locations using a flexible tape measure. These circumferential measurements are then used to calculate the arm volume by modeling the arm segments as truncated cones and summing the volumes of the individual segments. The variable measured is the arm volume, which is a continuous quantitative variable expressed in units of volume in milliliters (mL).

The 30-second elbow extension test is a functional assessment designed to measure the muscular endurance of the elbow extensors. In this test, the participant is seated or standing and holds a 1 kg weight in their hand. The arm starts in a flexed position with the elbow bent at approximately 90 degrees. The participant then extends the elbow fully and returns to the starting flexed position, repeating this movement as many times as possible within a 30-second period. The number of complete flexion-extension cycles performed within the timeframe is counted and recorded. The primary variable measured in this test is the number of repetitions completed within the 30-second timeframe. This is a quantitative variable representing the muscular endurance of the elbow extensors. Specifically, it is a discrete variable since it counts the number of distinct repetitions performed.

The test is particularly useful for evaluating older adults but can also be applied to younger populations and athletes. The primary objective of the 30CST is to measure the number of times a participant can transition from a seated to a standing position and back to seated within a 30-second period. This test is part of the Fullerton Functional Fitness Test Battery and was developed to overcome the limitations of the five or ten repetition sit-to-stand tests, which often exhibit a floor effect in older adults. The measurement that it is used in this test is a quantitative discrete variable.

The C-reactive protein (CRP) is a blood test that measures the level of the CRP protein in the blood. CRP is produced by the liver in response to inflammation in the body. The change in CRP levels measured from blood samples can be used to assess the degree of inflammation and monitor the effectiveness of treatment. It is measured in Milligrams per deciliter (mg/dL).

The neutrophil-to-lymphocyte ratio (NLR) is a simple calculation obtained by dividing the absolute neutrophil count by the absolute lymphocyte count from a complete blood count with differential. It serves as an indicator of systemic inflammation, with higher values reflecting an increased inflammatory state, it is measured in mm³.

The RCB score is calculated based on several pathological parameters, including the size of the residual tumor, the percentage of the tumor that is invasive, the extent of lymph node involvement, and the size of the largest nodal metastasis. The RCB score is a continuous index that categorizes patients into four classes based on the level of residual disease: RCB-0: Pathologic complete response (no residual invasive cancer), RCB-I: Minimal residual disease, RCB-II: Moderate residual disease and RCB-III: Extensive residual disease.

Pathological complete response is a critical endpoint in the evaluation of neoadjuvant chemotherapy for breast cancer. It is defined as the absence of residual invasive cancer in the breast and axillary lymph nodes following treatment. This response is considered a surrogate marker for long-term outcomes such as overall survival and event-free survival. Is a binary outcome variable that indicates whether a patient achieved complete eradication of invasive cancer in the breast and lymph nodes after receiving neoadjuvant chemotherapy for breast cancer.

Low-Density Lipoprotein (LDL) measurement in a blood sample using the enzymatic method will be performed. This method involves several enzymatic reactions to quantify the levels of cholesterol and triglycerides. The Friedewald formula is then used to calculate LDL cholesterol (LDL-C) when direct measurement isn't feasible. The formula is:

LDL-C=Total Cholesterol-HDL Cholesterol-(Triglycerides5)LDL-C=Total Cholesterol-HDL Cholesterol-(5Triglycerides) Here, Total Cholesterol, HDL Cholesterol, and Triglycerides are measured enzymatically. The triglyceride value is divided by 5 to estimate Very Low-Density Lipoprotein (VLDL) cholesterol. The units for these measurements are typically milligrams per deciliter (mg/dL).

In this context, the variable type for LDL cholesterol is continuous, as it can take on any value within a range and is measured on a continuous scale. The unit of measurement is Milligrams per deciliter (mg/dL).

HDL cholesterol in blood is measured using the enzymatic method, which involves specific enzymatic reactions. A blood sample is prepared and treated to isolate HDL cholesterol. Enzymes such as cholesterol esterase hydrolyze HDL cholesterol esters into free cholesterol. Cholesterol oxidase then oxidizes the free cholesterol, producing hydrogen peroxide (H₂O₂). In the presence of peroxidase, H₂O₂ reacts with a chromogenic substrate to produce a colored compound. The intensity of this color, measured spectrophotometrically, is directly proportional to the HDL cholesterol concentration. A calibration curve, generated using known HDL cholesterol standards, allows determination of the sample's HDL cholesterol concentration by comparing color intensity. The unit of measurement is Milligrams per deciliter (mg/dL).

The change in ω-3 fatty acids in the red blood cell (RBC) membrane is measured to assess alterations in lipid profiles. A blood sample is collected, and RBCs are isolated. Lipids are extracted from the RBC membrane using solvents, and the extracted lipids are converted to fatty acid methyl esters (FAMEs). These FAMEs are analyzed using gas chromatography, which separates and quantifies individual fatty acids. The ω-3 fatty acids are expressed as a percentage of total fatty acids.

The change in ω-6 fatty acids in the red blood cell (RBC) membrane is measured to evaluate alterations in lipid profiles. A blood sample is collected, and RBCs are isolated. Lipids are extracted from the RBC membrane using solvents, and these lipids are converted to fatty acid methyl esters (FAMEs). The FAMEs are analyzed using gas chromatography, which separates and quantifies individual fatty acids. The ω-6 fatty acids are expressed as a percentage of total fatty acids.

This instrument provides comprehensive, quantitative information on individual diets by querying respondents about the type and quantity of all food and beverages consumed in the previous 24 hours. This method yields data that can be analyzed to assess dietary patterns, food groups, or nutrient intake. To analyze the nutrient content, the food data must be matched with nutrient information from a food composition database, allowing for the estimation of mean intakes of foods and nutrients.