Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449417
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-09
Brief Title:
Aurora A Human-centered Program for Breast Cancer Patients in Chile Easing Neoadjuvant Chemotherapys Effects
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Auroras Impact on Mitigating Adverse Effects of Neoadjuvant Chemotherapy in Breast Cancer Patients in Chiles Metropolitan Region
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Aurora
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 Auroras patient perception of behavior change will be addressed by analyzing the patients records in a journal Moreover the perceived value of Auroras design attributes influencing behavior change will be studied through in-depth interviews
Preliminary results describe Auroras 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 interventions impact on patient outcomes refine the design based on user feedback and explore potential relationships among physical activity fatty acid metabolism and chemotherapy response
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 Auroras patient perception of behavior change will be addressed by analyzing the patients records in a journal Moreover the perceived value of Auroras design attributes influencing behavior change will be studied through in-depth interviews
Preliminary results describe Auroras 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 interventions 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 cancers 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 activityThe 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 patients 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 programThe 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 participants 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 baselineThe experimental procedures involve determining physical activity levels physical activity adherence quality of life and Auroras 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 Auroras 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 patients 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 p005 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 Pearsons chi-square tests or non-parametric tests respectively for data distribution
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 patients 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 programThe 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 participants 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 baselineThe experimental procedures involve determining physical activity levels physical activity adherence quality of life and Auroras 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 Auroras 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 patients 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 p005 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 Pearsons chi-square tests or non-parametric tests respectively for data distribution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None