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

NCT06449417 | Not Yet Recruiting

• 1 other identifier: 230126002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer

Keywords

Physical Activity; Quality of Life; Fatty Acids

Outcome Measures

Primary Outcomes (1)

• Quality of Life Perception Score

  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.

  9 weeks

Secondary Outcomes (15)

• Patient Perception

  9 weeks

• 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 arm volume measured with the 6 Measures Assessment of Arm Volume 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

Study Arms (2)

Aurora Training Group

EXPERIMENTAL

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.

Behavioral: Experimental Aurora Training

Control Group

NO INTERVENTION

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.

Interventions

Experimental Aurora Training BEHAVIORAL

Patients will be asked to record their physical activity in the logbook every week, at the end of the intervention, each patient will have to dedicate a letter to another patient who will receive the same Aurora Kit.

Aurora Training Group

Eligibility Criteria

• Age: Up to 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Related Publications (4)

• Ramirez 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 BACKGROUND

• Acevedo 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 BACKGROUND

• Valenzuela 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 BACKGROUND

• Montt-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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Viviana Montecinos, Professor

  Pontifica Universidad católica de Chile

  STUDY DIRECTOR

Central Study Contacts

Denise Montt-Blanchard, Professor

CONTACT

56991295974; denisemontt@uc.cl

Karol Ramírez, Professor

CONTACT

56984168444; kramirezp@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind statistician
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a mixed-methods Randomized Control Trial evaluating the impact of Aurora, a human-centered design, on breast cancer patients undergoing neoadjuvant chemotherapy in the Metropolitan Region of Chile. The study measures quantitative and qualitative variables over a 9-week intervention. The control group comprises patients without Aurora. The primary outcome is quality of life, with secondary outcomes including functional capacity and tumor progression. The study includes sociodemographic data extraction, baseline and intervention end measurements, and correlations between variables. The Aurora program integrates motivation, peer learning, and community support. The hypothesis is that Aurora enhances the biopsychosocial effects and mitigates adverse physical and biological consequences of breast cancer by promoting physical activity.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: June 10, 2024
• Study Start: January 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: March 15, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share