Clinical trial · Interventional
Aurora: a Human-centered Program for Breast Cancer Patients in Chile, Easing Neoadjuvant Chemotherapy's Effects
Aurora's Impact on Mitigating Adverse Effects of Neoadjuvant Chemotherapy in Breast Cancer Patients in Chile's Metropolitan Region.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental Aurora Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aurora Training Group
- description
- The experimental group will receive an online class of the benefits of physical activity for breast cancer patients, followed by the delivery of the human centered design intervention program.The Aurora kit is a plastic container including a resistance band, two 2 kg dumbbells, a therapeutic ball, an arm volume measurement tape, a hydration bottle for the patient, a leaflet with a guide of recommended exercises, and the logbook journal. The intervention lasts 9 weeks.
- interventionNames
- Behavioral: Experimental Aurora Training
- type
- NO_INTERVENTION
- label
- Control Group
- description
- The control group will receive an online class of the benefits of physical activity for breast cancer patients, followed by the delivery of the control kit.The control kit is a tote bag including a hydration bottle for the patient, and a logbook journal with blanc pages. The intervention lasts 9 weeks.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (4)
- BACKGROUNDRamirez K, Acevedo F, Herrera ME, Ibanez C, Sanchez C. [Physical activity and breast cancer]. Rev Med Chil. 2017 Jan;145(1):75-84. doi: 10.4067/S0034-98872017000100011. Spanish. PMID 28393973
- BACKGROUNDAcevedo F, Walbaum B, Medina L, Merino T, Camus M, Puschel K, Ramirez K, Manzor M, Veglia P, Martinez R, Guerra C, Navarro M, Bauerle C, Dominguez F, Sanchez C. Clinical characteristics, risk factors, and outcomes in Chilean triple negative breast cancer patients: a real-world study. Breast Cancer Res Treat. 2023 Jan;197(2):449-459. doi: 10.1007/s10549-022-06814-x. Epub 2022 Nov 21. PMID 36414796
- BACKGROUNDValenzuela R, Walbaum B, Farias C, Acevedo F, Vargas C, Bennett JT, Bravo ML, Pinto MP, Medina L, Merino T, Ibanez C, Parada A, Sanchez C. High linoleic acid levels in red blood cells predict a poor response to neoadjuvant chemotherapy in human epidermal growth factor receptor type 2-positive breast cancer patients. Nutrition. 2024 May;121:112357. doi: 10.1016/j.nut.2024.112357. Epub 2024 Jan 9. PMID 38430738
- DERIVEDMontt-Blanchard D, Ramirez-Parada K, Montecinos V. Home-based patient-centered physical activity program for quality of life preservation during neoadjuvant chemotherapy in breast cancer: the AURORA randomized controlled trial protocol. Trials. 2026 Jan 7;27(1):12. doi: 10.1186/s13063-025-09301-y. PMID 41501916