Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429189
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-03
Brief Title:
Home-Combo an Online Home-based Combined Exercise Intervention for Women With Breast Cancer
Sponsor:
Grupo Lusófona
Organization:
Grupo Lusófona
Study Overview
Official Title:
An Online Home-based Combined Exercise Intervention With Self-selected Intensity for Women With Breast Cancer The Home-Combo Randomized Controlled Trial
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:
None
Brief Summary:
Background Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer BC Chemoresistance can lead to treatment failure A relative dose intensity of chemotherapy 85 is associated with a worse diagnosis and lower treatment efficacy Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability The need for a pleasant and sustainable exercise practice is important considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed
Background Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer BC Chemoresistance can lead to treatment failure A relative dose intensity of chemotherapy 85 is associated with a worse diagnosis and lower treatment efficacy Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability The need for a pleasant and sustainable exercise practice is important considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed
Purpose This study will be a 2-arm pragmatic randomized controlled trial Home-Combo which will target Portuguese women with a breast cancer diagnosis undergoing either neo-adjuvant or adjuvant chemotherapy The Home-Combo study primarily aims to investigate the effects of a structured supervised home-based combined exercise intervention with self-selected intensity conducted across the chemotherapy treatment period on the chemotherapy completion rates of women with BC Secondly this study intends to analyze the impact of this intervention on functional performance body composition PA levels and quality of life A 3-month follow-up will be performed to investigate short-term outcomes and active lifestyle sustainability post-intervention
Methods A 2-arm randomized controlled trial will be implemented in a real-world exercise setting to compare an online structured and supervised group aerobic and strength exercise intervention with an active control group during chemotherapy treatments The study recruitment goal is 98 women with a BC diagnosis stage I-III who are scheduled to have neoadjuvant or adjuvant chemotherapy Outcome measures will be obtained at baseline mid-treatment 3 months post-intervention 6 months and 3-month follow-up A mediation analysis will also be conducted
Hypothesis 1 Women in the intervention will have a better completion rate than those in the control group
Hypothesis 2 Women in the intervention will present better functional performance body composition PA levels and quality of life than the control group
Hypothesis 3 In the post-intervention period women in the intervention group will maintain a more physically active lifestyle than women in the control group
Background Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer BC Chemoresistance can lead to treatment failure A relative dose intensity of chemotherapy 85 is associated with a worse diagnosis and lower treatment efficacy Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability The need for a pleasant and sustainable exercise practice is important considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed
Purpose This study will be a 2-arm pragmatic randomized controlled trial Home-Combo which will target Portuguese women with a breast cancer diagnosis undergoing either neo-adjuvant or adjuvant chemotherapy The Home-Combo study primarily aims to investigate the effects of a structured supervised home-based combined exercise intervention with self-selected intensity conducted across the chemotherapy treatment period on the chemotherapy completion rates of women with BC Secondly this study intends to analyze the impact of this intervention on functional performance body composition PA levels and quality of life A 3-month follow-up will be performed to investigate short-term outcomes and active lifestyle sustainability post-intervention
Methods A 2-arm randomized controlled trial will be implemented in a real-world exercise setting to compare an online structured and supervised group aerobic and strength exercise intervention with an active control group during chemotherapy treatments The study recruitment goal is 98 women with a BC diagnosis stage I-III who are scheduled to have neoadjuvant or adjuvant chemotherapy Outcome measures will be obtained at baseline mid-treatment 3 months post-intervention 6 months and 3-month follow-up A mediation analysis will also be conducted
Hypothesis 1 Women in the intervention will have a better completion rate than those in the control group
Hypothesis 2 Women in the intervention will present better functional performance body composition PA levels and quality of life than the control group
Hypothesis 3 In the post-intervention period women in the intervention group will maintain a more physically active lifestyle than women in the control group
Detailed Description:
Study setting The Home-Combo study will take place in the Algarve and the sample will be recruited by medical referral from various public and private hospitals across the region
The intervention design will consider the PAexercise preferences perceived barriers and facilitators of women with BC This information will be collected before the intervention through a mixed-methods qualitative study that will include a survey and focus groups The intervention will be conducted online to ensure the participants safety during the chemotherapy treatment phase as they may have compromised immunity Also this option was made to attenuate participants burden caused by commuting requirements Participants will be enrolled in two cohorts
Criteria for discontinuing or modifying allocated interventions Participants will be informed in the pre-study initial meeting that they may leave the study anytime Participants will be asked to refrain from continuing the intervention if a worsening clinical condition prevents them from exercising and performing the assessments safely The exercise program might be reviewed and tailored to the participants condition across the intervention
Strategies to improve adherence Before implementing this study a survey and focus-group-based study will be performed to adjust the exercise program to the preferences perceived barriers and facilitators of women with a breast cancer diagnosis considering the environmental and cultural context from where the intervention will be conducted The supervising professional will monitor adherence to the supervised sessions through presence registration This study will also consider the participants adherence to the control group To attempt dropout minimization the investigators will have an active control group
Concomitant care Physiotherapy treatments prescribed by the participants primary physician and any exercises prescribed to be performed at home prescribed by the physiotherapist will be allowed during the intervention Participants in the study will be asked not to engage in other exercise and PA programs or activities outside the program Participants in the control group will not be prohibited from performing physical activities like brisk walking
Sample size Considering this study design sample size calculations were made for the primary outcome with a factorial variance analysis with repeated measures as reference statistical analysis giving an initial estimation of 82 participants Based on previous findings and considering a 20 dropout the sample size was estimated at 98 participants with a moderate effect size a005 statistical power080 according to Cohens D calculations using G Power 31
Recruitment Recruitment will occur through medical referrals from primary physicians of several public and private hospitals in the Algarve region Additionally the project will be presented at breast cancer-themed congresses and events and digital flyers with information about the study will be made to assist in disseminating the project and the recruitment process A research team member will then contact patients referred by the doctors to receive detailed information about the study Optionally patients can call the research team directly or contact them through email if they prefer After confirming eligibility criteria and interest in participating in the study patients will be asked to attend an initial session where more information will be given and the informed consent will be signed During that session participants will be told they are not obliged to participate in the study and may decide to leave the project Consent for data collection or sharing will also be obtained
Data collection methods Assessments will be conducted in standardized conditions in a clinical setting in a calm and comfortable environment in small groups and performed by a qualified exercise professional The assessments will be conducted in the morning starting with the body composition measurements followed by a 15-minute pause so participants can eat since they will be weighted while fasting preceded by a 10-minute warm-up with general movements to mobilize big muscle groups and the physical tests that will be performed in the following order shoulder angular measurements strength mobility and aerobic endurance Participants will be divided into small groups to facilitate instruction and conduction of the tests Participants will receive the accelerometers one week before the field tests and return them on the physical assessment day After the field measurements all questionnaires will be delivered and answered through email Google Forms
Plans to promote retention The conducting exercise professional will control participants adherence to the exercise program through a presence registry collected by the research team member with access to the list of participants numbers After the session the non-interventionist research team member will pass the presence list to the respective numbers of the participants for program adherence analysis If a participant fails to attend a session contact will be made to ensure the participants welfare and motivate them to participate in the next session The data analysis will not consider participants who fail to attend 50 or more sessions Positive feedback will be given to the participants during the sessions as positive feedback enhances feelings of competence enjoyment and interest in the activity 86 Additionally participants will be encouraged to keep an activity diary where they may register all activities performed autonomously Participants will be contacted one week before the assessment to confirm their availability and presence Data from participants who fail to perform the assessments during the intervention period will be excluded from data analysis After the intervention participants will be contacted monthly to check their well-being and keep their interest and motivation in engaging in the follow-up assessment
Data management All the data collected in this study will be kept confidential computerized and encrypted in a database without any elements that may allow identification of the participants After the participants have expressed interest and written informed consent a number corresponding to the participant ID during the study will be provided When the participant receives her ID number all data inserted in the databases will not be directly linked to the participants personal identification A dataset will be created for each assessment time point All datasets will be maintained by the members responsible for the investigation on a secure server of CIDEFES-UL for ten years and will be used exclusively for research purposes Datasets used for specific analyses or to develop sub-studies will contain only the necessary variables and the demographical indicators provided to the research team members upon request to the leading investigator
Statistical methods All data will be analyzed using IBM SPSS version 290 Factorial ANCOVAS with repeated measures will be used for the primary and secondary outcomes adjusted for potential covariates eg concomitant treatments BC diagnosis neo-adjuvant adjuvant chemotherapy Independent sample T-tests will be used to compare results between groups at each time point considering chemotherapy completers versus non-completers A Fishers exact test will compare the proportion of participants who needed chemotherapy adjustments from those who did not The intention-to-treat analysis will be conducted to ensure that all participants are included in the overall assessment considering their compliance with the study protocol The Last Observation Carried Forward method will be used to input missing data values A per-protocol analysis will also be conducted without participants who failed to complete at least 50 of the training sessions Normality plots and Kolmogorov-Smirnov tests will be performed to test the normality of outcome variables If normality is not satisfied non-parametric tests will be applied eg Krustal-Wallis Mediators of change ie mechanisms by which RDI will be explored using structural equation modeling AMOS 180 and multiple mediation analysis PROCESS macro for SPSS Putative candidates will include treatment eg dose planned vs given dose planned cycles minimummaximum treatment interruption ratios response to treatment percentage of participants who needed dose adjustments and the mean value of dose adjustment and physiological eg body composition functional performance handgrip strength PA levels variables Mediation occurs when a causal effect of an independent variable occurs on a dependent variable partly or entirely explained by a mediator Indirect effects testing will be performed using Preacher and Hayes procedures
Data monitoring A data monitoring committee will not be required for this trial as the interventions pose minimal risk and participants will be protected by personal insurance throughout the study
Harms All participants will have their adverse events monitored throughout the study whether directly related to the intervention or not if applicable This monitoring will be done through self-reporting at the start of each session registered for analysis and report purposes or by their primary care physicians Participants will be advised to contact the clinical team if they have difficulties
Auditing Two authors will supervise all trial procedures and cross-check the interventionist actions and study processes Additionally an independent person external to the project will review the protocol
Research ethics approval This study has received ethical approval from the collaborating hospital UAIF 0692024 This trial will follow the World Medical Associations Declaration of Helsinki for Human Studies
Consent or assent Healthcare professionals will approach potential participants to determine if they are interested in participating If they express interest they will be referred to a research team member who will contact them Additionally interested participants will be allowed to share the study information with other women who have been diagnosed with breast cancer If any of these women express interest in participating they will also be considered after obtaining medical clearance Once the eligibility criteria for the study are confirmed and the women express their interest in participating they will receive the Informed Consent through email In the informational session women will be asked to digitally fill out and sign the Informed Consent It will be clear to the participants that they can withdraw their consent anytime After the informational session a PDF copy of the signed Informed Consent will be emailed to each participant The research team will also take additional measures to collect and share the participants data
The intervention design will consider the PAexercise preferences perceived barriers and facilitators of women with BC This information will be collected before the intervention through a mixed-methods qualitative study that will include a survey and focus groups The intervention will be conducted online to ensure the participants safety during the chemotherapy treatment phase as they may have compromised immunity Also this option was made to attenuate participants burden caused by commuting requirements Participants will be enrolled in two cohorts
Criteria for discontinuing or modifying allocated interventions Participants will be informed in the pre-study initial meeting that they may leave the study anytime Participants will be asked to refrain from continuing the intervention if a worsening clinical condition prevents them from exercising and performing the assessments safely The exercise program might be reviewed and tailored to the participants condition across the intervention
Strategies to improve adherence Before implementing this study a survey and focus-group-based study will be performed to adjust the exercise program to the preferences perceived barriers and facilitators of women with a breast cancer diagnosis considering the environmental and cultural context from where the intervention will be conducted The supervising professional will monitor adherence to the supervised sessions through presence registration This study will also consider the participants adherence to the control group To attempt dropout minimization the investigators will have an active control group
Concomitant care Physiotherapy treatments prescribed by the participants primary physician and any exercises prescribed to be performed at home prescribed by the physiotherapist will be allowed during the intervention Participants in the study will be asked not to engage in other exercise and PA programs or activities outside the program Participants in the control group will not be prohibited from performing physical activities like brisk walking
Sample size Considering this study design sample size calculations were made for the primary outcome with a factorial variance analysis with repeated measures as reference statistical analysis giving an initial estimation of 82 participants Based on previous findings and considering a 20 dropout the sample size was estimated at 98 participants with a moderate effect size a005 statistical power080 according to Cohens D calculations using G Power 31
Recruitment Recruitment will occur through medical referrals from primary physicians of several public and private hospitals in the Algarve region Additionally the project will be presented at breast cancer-themed congresses and events and digital flyers with information about the study will be made to assist in disseminating the project and the recruitment process A research team member will then contact patients referred by the doctors to receive detailed information about the study Optionally patients can call the research team directly or contact them through email if they prefer After confirming eligibility criteria and interest in participating in the study patients will be asked to attend an initial session where more information will be given and the informed consent will be signed During that session participants will be told they are not obliged to participate in the study and may decide to leave the project Consent for data collection or sharing will also be obtained
Data collection methods Assessments will be conducted in standardized conditions in a clinical setting in a calm and comfortable environment in small groups and performed by a qualified exercise professional The assessments will be conducted in the morning starting with the body composition measurements followed by a 15-minute pause so participants can eat since they will be weighted while fasting preceded by a 10-minute warm-up with general movements to mobilize big muscle groups and the physical tests that will be performed in the following order shoulder angular measurements strength mobility and aerobic endurance Participants will be divided into small groups to facilitate instruction and conduction of the tests Participants will receive the accelerometers one week before the field tests and return them on the physical assessment day After the field measurements all questionnaires will be delivered and answered through email Google Forms
Plans to promote retention The conducting exercise professional will control participants adherence to the exercise program through a presence registry collected by the research team member with access to the list of participants numbers After the session the non-interventionist research team member will pass the presence list to the respective numbers of the participants for program adherence analysis If a participant fails to attend a session contact will be made to ensure the participants welfare and motivate them to participate in the next session The data analysis will not consider participants who fail to attend 50 or more sessions Positive feedback will be given to the participants during the sessions as positive feedback enhances feelings of competence enjoyment and interest in the activity 86 Additionally participants will be encouraged to keep an activity diary where they may register all activities performed autonomously Participants will be contacted one week before the assessment to confirm their availability and presence Data from participants who fail to perform the assessments during the intervention period will be excluded from data analysis After the intervention participants will be contacted monthly to check their well-being and keep their interest and motivation in engaging in the follow-up assessment
Data management All the data collected in this study will be kept confidential computerized and encrypted in a database without any elements that may allow identification of the participants After the participants have expressed interest and written informed consent a number corresponding to the participant ID during the study will be provided When the participant receives her ID number all data inserted in the databases will not be directly linked to the participants personal identification A dataset will be created for each assessment time point All datasets will be maintained by the members responsible for the investigation on a secure server of CIDEFES-UL for ten years and will be used exclusively for research purposes Datasets used for specific analyses or to develop sub-studies will contain only the necessary variables and the demographical indicators provided to the research team members upon request to the leading investigator
Statistical methods All data will be analyzed using IBM SPSS version 290 Factorial ANCOVAS with repeated measures will be used for the primary and secondary outcomes adjusted for potential covariates eg concomitant treatments BC diagnosis neo-adjuvant adjuvant chemotherapy Independent sample T-tests will be used to compare results between groups at each time point considering chemotherapy completers versus non-completers A Fishers exact test will compare the proportion of participants who needed chemotherapy adjustments from those who did not The intention-to-treat analysis will be conducted to ensure that all participants are included in the overall assessment considering their compliance with the study protocol The Last Observation Carried Forward method will be used to input missing data values A per-protocol analysis will also be conducted without participants who failed to complete at least 50 of the training sessions Normality plots and Kolmogorov-Smirnov tests will be performed to test the normality of outcome variables If normality is not satisfied non-parametric tests will be applied eg Krustal-Wallis Mediators of change ie mechanisms by which RDI will be explored using structural equation modeling AMOS 180 and multiple mediation analysis PROCESS macro for SPSS Putative candidates will include treatment eg dose planned vs given dose planned cycles minimummaximum treatment interruption ratios response to treatment percentage of participants who needed dose adjustments and the mean value of dose adjustment and physiological eg body composition functional performance handgrip strength PA levels variables Mediation occurs when a causal effect of an independent variable occurs on a dependent variable partly or entirely explained by a mediator Indirect effects testing will be performed using Preacher and Hayes procedures
Data monitoring A data monitoring committee will not be required for this trial as the interventions pose minimal risk and participants will be protected by personal insurance throughout the study
Harms All participants will have their adverse events monitored throughout the study whether directly related to the intervention or not if applicable This monitoring will be done through self-reporting at the start of each session registered for analysis and report purposes or by their primary care physicians Participants will be advised to contact the clinical team if they have difficulties
Auditing Two authors will supervise all trial procedures and cross-check the interventionist actions and study processes Additionally an independent person external to the project will review the protocol
Research ethics approval This study has received ethical approval from the collaborating hospital UAIF 0692024 This trial will follow the World Medical Associations Declaration of Helsinki for Human Studies
Consent or assent Healthcare professionals will approach potential participants to determine if they are interested in participating If they express interest they will be referred to a research team member who will contact them Additionally interested participants will be allowed to share the study information with other women who have been diagnosed with breast cancer If any of these women express interest in participating they will also be considered after obtaining medical clearance Once the eligibility criteria for the study are confirmed and the women express their interest in participating they will receive the Informed Consent through email In the informational session women will be asked to digitally fill out and sign the Informed Consent It will be clear to the participants that they can withdraw their consent anytime After the informational session a PDF copy of the signed Informed Consent will be emailed to each participant The research team will also take additional measures to collect and share the participants data
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