Trial Title:
Home-Combo: an Online Home-based Combined Exercise Intervention for Women With Breast Cancer
NCT ID:
NCT06429189
Condition:
Breast Cancer
Chemotherapy Effect
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Home-based exercise
Functional performance
Body composition
Physical activity
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
2-arm pragmatic and superiority randomized controlled trial with an intervention and an
active control group, with a 1:1 allocation ratio.
Participants in this group will perform a home-based combined exercise program throughout
their chemotherapy treatments, starting within 1-2 weeks of its start and ending within
3-4 weeks post-treatment completion.
Women randomized to the control group will receive weekly 30-minute supervised sessions
with breathing, stretching, relaxation exercises, and meditation during the intervention
period.
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
Participants will be told they are part of an exercise intervention without any mention
of a control group.
Healthcare professionals responsible for the chemotherapy prescription and administration
and registering all clinical information will be blinded to the participants' groups.
None of the research team members will know the number of participants, so data analysis
will be performed in a blinded setting.
If, at any given moment, a participant reveals her number to a research team member, all
posterior data from that participant will be disregarded.
If a participant decides to leave the study or must abandon it due to health
complications, the team member with the number information will be informed, and data
will be disregarded from the analysis.
Intervention:
Intervention type:
Behavioral
Intervention name:
Home-based combined exercise program with self-selected intensity
Description:
Before the beginning of the exercise program, participants will receive an education
session on how to use Borg's Perceived Rate of Exertion Scale (RPE) to monitor their
effort during aerobic and resistance training and tips on when they may increase the
exercise intensity. During the training sessions, participants in the intervention group
will be asked to choose their preferred load to execute each exercise in the resistance
component, told to perform the aerobic exercises at their preferred speed, and informed
that they can stop exercising whenever they need to rest. The exercise professional may
suggest increasing loads in specific exercises, but these increases will not be imposed
on the participants. Attendance to the sessions in the intervention and control groups
will be registered. Additionally, women in this group will be encouraged to perform brisk
walking at their preferred intensity and receive a pedometer to increase walking
motivation.
Arm group label:
Active control group
Arm group label:
Home-based combined exercise
Other name:
Home-combo
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.
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 PA/exercise 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 participant's 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 (a=0.05; statistical power=0.80) according to Cohen's D
calculations, using G* Power 3.1.
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 participant's 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 participant's 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 29.0). Factorial
ANCOVAS with repeated measures will be used for the primary and secondary outcomes,
adjusted for potential covariates (e.g., 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 Fisher's 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 (e.g., Krustal-Wallis). Mediators of change (i.e., mechanisms by which
RDI) will be explored using structural equation modeling (AMOS 18.0) and multiple
mediation analysis (PROCESS macro for SPSS). Putative candidates will include treatment
(e.g., dose planned vs. given dose, planned cycles minimum/maximum, treatment
interruption ratios, response to treatment, percentage of participants who needed dose
adjustments, and the mean value of dose adjustment), and physiological (e.g., 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 069/2024). This trial will follow the World Medical Association's
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Breast cancer stage I-III diagnosis
- Scheduled to receive neoadjuvant or adjuvant chemotherapy
- Have acess to a computer
Exclusion Criteria:
- Medical conterindication to perform exercise or physical assessments due to
concomitant comorbidity
- Non-controlled health conditions or diseases
- Psychological illness
- Currently enrolled in a structured exercise program
- Unable to complete the entire program (e.g., due to scheduled surgery or personal
commitments)
- Pregnancy
- Worsening of clinical condition during intervention
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universidade Lusófona, Centro de Lisboa
Address:
City:
Lisboa
Zip:
1749-024
Country:
Portugal
Contact:
Last name:
Pedro B. Júdice, PhD
Phone:
217515500
Email:
p5274@ulusofona.pt
Contact backup:
Last name:
Eliana V. Carraça, PhD
Phone:
217515500
Email:
p4890@ulusofona.pt
Investigator:
Last name:
Pedro GF Ramos, Msc
Email:
Principal Investigator
Investigator:
Last name:
Nuno Dias, Msc
Email:
Sub-Investigator
Start date:
November 10, 2024
Completion date:
October 10, 2025
Lead sponsor:
Agency:
Grupo Lusófona
Agency class:
Other
Collaborator:
Agency:
Universidade Lusófona de Humanidades e Tecnologias
Agency class:
Other
Collaborator:
Agency:
Grupo HPA
Agency class:
Other
Collaborator:
Agency:
Associação Oncológica do Algarve
Agency class:
Other
Collaborator:
Agency:
Liga Portuguesa Contra o Cancro
Agency class:
Other
Collaborator:
Agency:
Centro Hospitalar Universitario do Algarve
Agency class:
Other
Source:
Grupo Lusófona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06429189
