Trial Title:
Aurora: a Human-centered Program for Breast Cancer Patients in Chile, Easing Neoadjuvant Chemotherapy's Effects
NCT ID:
NCT06449417
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Physical Activity
Quality of Life
Fatty Acids
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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.
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Masking description:
Blind statistician
Intervention:
Intervention type:
Behavioral
Intervention name:
Experimental Aurora Training
Description:
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.
Arm group label:
Aurora Training Group
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.
Detailed description:
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.
Week 4-13: Participants are randomized using minimization, considering each new
participant's characteristics, such as age and cancer stage, which are determinant
factors for physical activity adherence. Participants receive kits tailored to their
assigned group, complete with instructions on using each item and what to document in the
provided journal over the nine-week intervention period. Participants in the intervention
group receive the Aurora human centered design product system, while those in the control
group receive a kit with the same hydration bottle, measurement tape, a logbook journal
with blank pages, and an electronic step count wristband, all packaged in an
Aurora-branded tote bag. Weekly follow-ups ensure compliance with the protocol and record
any adverse events.
Week 13-16: The research team coordinates the return of the kits. Participants in the
intervention group return the container with all the sports equipment and the dedication
letter to the next participant. The team confirms whether the participant wishes to keep
the journal, and if so, each page is photographed for record-keeping before returning it
to the participant. The participant also keeps the water bottle. In the control group,
the same procedure is followed for the journal delivery, and participants keep the tote
bag and the water bottle. They return the measurement tape and the pedometer. Prior to
surgery, each patient undergoes routine blood sampling for testing, following the same
procedure as at baseline.The experimental procedures involve determining physical
activity levels, physical activity adherence, quality of life, and Aurora's perception.
Physical activity levels are measured according to the number of exercise sessions
reported on a weekly basis and their compliance with the reported minimum of 3 weekly
sessions for breast cancer patients in Chile. The intervention group receives specially
designed pages in their Aurora journal to register this information, whereas the control
group has blank pages to record the data. Physical activity time is evaluated at baseline
and at the end of the intervention with the International Physical Activity questionnaire
in its short form. Physical activity intensity is measured using wrist pedometers
provided by the Oncology physical therapy unit at Complejo Asistencial Dr. Sótero del
Río. Quality of Life is assessed using the European Organization for Research and
Treatment of Cancer (EORTC) QLQ-BR23 questionnaire at baseline and at the end of the
intervention. To understand Aurora's perception, two methods are assessed at the end of
the intervention: a thematic analysis of the Aurora journals and a system design
evaluation. The reflections recorded in the Aurora logbook journal are transcribed and
analyzed using an inductive thematic analysis following the COM-B constructs. The system
design evaluation is conducted in online, in-depth, focused interview sessions with
participants from the intervention group at the end of the last patient's cycle.
The method for extracting and measuring fatty acids (FA) involves drawing 5 ml of venous
blood after a 12-hour fast, separating red blood cells, and extracting plasma membranes
following a specific procedure. The FA from these membranes are then extracted using the
Folch method, which uses a mixture of chloroform and methanol to extract lipids. The FA
are derivatized to form fatty acid methyl esters (FAMEs) for analysis by gas
chromatography to determine the fatty acid composition. Neutrophil and lymphocyte counts
ratio (NLR) will be obtained from a complete blood count, and omega-3 (⍵-3) and omega-6
(⍵-6) PUFAs will be determined by extracting total lipids from red blood cells and total
plasma. Residual cancer burden (RCB) and pathological complete response (pCR) will be
calculated post-surgery based on data from electronic medical records to assess tumor
progression.
The statistical analysis will be performed using R Studio, and the results will be
analyzed under the intention-to-treat principle. Descriptive, inferential, and
correlation analyses will be conducted, with statistical significance defined as p≤0.05.
Descriptive statistics will present the results as the mean and standard deviation for
continuous variables with a symmetrical distribution or as percentiles and range for
continuous variables with an asymmetrical distribution. Inferential statistics will
compare baseline characteristics and within-group and between-group differences using
t-tests, Pearson´s chi-square tests, or non-parametric tests, respectively, for data
distribution.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
N/A
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
January 1, 2025
Completion date:
March 15, 2026
Lead sponsor:
Agency:
Pontificia Universidad Catolica de Chile
Agency class:
Other
Source:
Pontificia Universidad Catolica de Chile
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06449417
