Aurora's Impact on Mitigating Adverse Effects of Neoadjuvant Chemotherapy in Breast Cancer Patients in Chile's Metropolitan Region.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Quality of Life Perception Score
研究概览
简要总结
Breast cancer is the most prevalent cancer worldwide and the leading cause of cancer death among women in Chile. The Aurora intervention program is designed to improve the quality of life and mitigate the physical consequences of breast cancer in patients undergoing neoadjuvant chemotherapy. It aims to promote physical activity through a human-centered design product system, incorporating elements of personal motivation, peer learning, and community engagement in alignment with the COM-B model.
In a 9-week randomized controlled trial, we will include 30 female patients under 70 years undergoing neoadjuvant therapy for breast cancer in the Metropolitan Region of Chile. Baseline and post-intervention measurements will assess biopsychosocial breast cancer effects through a questionnaire as well as adverse physical effects through functional capacity tests. Biological consequences will be evaluated through lipid profiling, inflammation biomarkers, and tumor progression. In addition, Aurora's patient perception of behavior change will be addressed by analyzing the patient's records in a journal. Moreover, the perceived value of Aurora's design attributes influencing behavior change will be studied through in-depth interviews.
Preliminary results describe Aurora's design process and indicate that it is well-received by patients, especially as its logbook is a valuable tool for self-reflection and progress tracking. The study anticipates the confirmation that significantly higher physical activity, improved quality of life, and enhanced functional capacity will be attained in the intervention group.
The Aurora intervention program represents a novel approach to support breast cancer patients undergoing chemotherapy, emphasizing physical activity, peer learning, and self-reflection. The integration of the behavior change COM-B model and a human-centered design provides a facilitating tool for tailored interventions for breast cancer patients' needs. Yet, the potential correlation between physical activity, fatty acid metabolism, and chemotherapy response necessitates further exploration.
The Aurora intervention program shows promise as a supportive tool for breast cancer patients undergoing neoadjuvant chemotherapy. Further research is imperative to evaluate the intervention's impact on patient outcomes, refine the design based on user feedback, and explore potential relationships among physical activity, fatty acid metabolism, and chemotherapy response.
详细描述
The research question of this project focuses on the quantitative and qualitative dimensions in health concerning temporality, specifically exploring and understanding health phenomena in a specific temporal context within the framework of the intervention with the Aurora human centered design product system therapeutic intervention program. The hypothesis is that the Aurora program significantly enhances the biopsychosocial breast cancer effects and mitigates breast cancer's adverse physical and biological consequences among women undergoing neoadjuvant chemotherapy in the Metropolitan Region of Chile by promoting physical activity. The main goal is to evaluate the impact of the Aurora product system therapeutic intervention program on enhancing the biopsychosocial effects and mitigating the adverse physical and biological consequences of breast cancer for women undergoing neoadjuvant chemotherapy in the Metropolitan Region of Chile by promoting physical activity.The specific objectives are:
i) Evaluate the impact of the Aurora human centered design product system therapeutic intervention program on Physical Activity levels (measured by intensity, time, and adherence) 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.
ii) Assess the effectiveness of the Aurora human centered design product system therapeutic intervention program in enhancing the biopsychosocial effects of breast cancer (measured by quality of life and patient´s perceptions) 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.
iii) Determine the extent to which the Aurora human centered design product system therapeutic intervention program mitigates the physical consequences of breast cancer (measured by functional capacity) 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.
iv) 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 LDL, HDL, and RBCm FA; inflammation by CRP and neutrophil to lymphocyte ratio; and tumor progression by residual cancer burden and pathological complete response) 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 study program consists of four main phases: Week 0-4: Patients provide informed consent, and sociodemographic data, breast cancer subtype, and stages are collected. An online educational session is held, detailing physical activity advantages and outlining recommended exercise types, durations, and frequencies for breast cancer patients. Participants' availability is gathered to schedule an online assessment, which includes the quality of life questionnaire, functional capacity evaluations, and a dietary survey. Blood samples are drawn from routine tests in coordination with their neoadjuvant chemotherapy indication or schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blind statistician
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women under 70 years old
- •Diagnosis of primary breast carcinoma,
- •Indication for neoadjuvant chemotherapy
- •Access to a safe physical space for performing PA
- •Connection to the Internet
- •Access to an electronic device for video conferencing
排除标准
- •Stage IV cancer (non-curative)
- •Medical contraindication to physical activity
- •Self-report of physical activity participation equivalent to the current governmental physical exercise recommendation guide
- •Body mass index lower than 18.5 kg/m2 or greater than 40 kg/m2.
结局指标
主要结局
Quality of Life Perception Score
时间窗: 9 weeks
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.
次要结局
- Change in lipid profile measured by High Density Lipoprotein on blood sample, at baseline and at the end of the program.(9 weeks)
- Change in lipid profile measured by Red Blood Cell membrane Fatty Acid w6 on blood sample, at baseline and at the end of the program.(9 weeks)
- Change in C-reactive protein measured in blood samples, at baseline and at the end of the program.(9 weeks)
- Change in Neutrophil-to-Lymphocyte Ratio in blood samples, at baseline and at the end of the program.(8 months)
- Lipid Profile(9 weeks)
- Change on aerobic capacity measured with the Two-Minute Walk Test at baseline and at the end of the program.(9 weeks)
- Change in upper extremity strength measured with the 30-second elbow extension test at baseline and at the end of the program.(9 weeks)
- Change in lower extremity strength measured with the 30 Seconds Sit-to-Stand Test, at baseline and at the end of the program.(9 weeks)
- Change in arm volume measured with the 6 Measures Assessment of Arm Volume at baseline and at the end of the program.(9 weeks)
- Residual cancer burden score after neoadjuvant treatment.(8 months)
- Patient Perception(9 weeks)
- Change in lipid profile measured by Low Density Lipoprotein on blood sample, at baseline and at the end of the program.(9 weeks)
- Change in lipid profile measured by Red Blood Cell membrane Fatty Acid w3 on blood sample, at baseline and at the end of the program.(9 weeks)
- Pathological complete response measured after neoadjuvant chemotherapy(8 months)
- Change in lipid profile measured by the 24-hour dietary recall questionnaire, at baseline and at the end of the program.(9 weeks)