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| Name | Class |
|---|---|
| Universidade do Porto | OTHER |
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The goal of this trial is to learn if a home-based exercise program (intervention) reduces fatigue and improves quality of life in adult patients with early breast cancer who are proposed for preoperative chemotherapy.
Conducted at Centro Hospitalar Universitário de Santo António, Porto, Portugal. It compares a structured exercise program prescribed by the physical and rehabilitation medicine team to routine counseling for physical activity by the medical oncologist.
All participants will:
Participants of the intervention-arm will additionally:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based exercise program | Experimental | Participants allocated to the intervention arm will follow a home-based program, consisting of two initially supervised explanatory sessions, followed by home sessions of muscular training (twice per week), complemented with additional periods of aerobic exercise (20-30min trice per week). They will also receive routine short counseling for promotion of physical activity. |
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| Short counselling for promotion of physical activity | Active Comparator | Participants allocated to the control arm will receive routine short counseling for promotion of physical activity, as recommended by the Portuguese Directorate-General of Health (Mendes R, et al. 2020) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based exercise program | Behavioral | The home-based program follows the National recommendations on Physical Exercise for Cancer Patients [Bruno RC, 2023]. It is logbook-guided and technology-enabled. It consists of:
The training sessions will be monitored by smartwatch heart rate measurements and self-notion of effort according to Borg Categorization [Borg GA, 1982] and recorded by the participants in the Mi Fitness application or an Exercise Diary.[Nilsen TS, 2018] |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | Changes in health-related quality of life, measured by EORTC QLQ-30, from baseline (T0) to 12 weeks of systemic therapy (T1) and to 1 month after surgery (T2) | From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| Fatigue | Changes in patient-reported fatigue, measured by FACIT-Fatigue, from baseline (T0) to 12 weeks of systemic therapy (T1) and to 1 month after surgery (T2) | From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | Change on exercise capacity, measured as 6MWT distance, from T0 to T1 and from T0 to T2. | From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| Physical activity levels |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphedema | Changes in arms circumferences from T0 to T2, and from T0 to 6-12m after the surgery. | From enrolement to up to 12 months after the end of intervention period. |
| Disease free survival | Time from the beginning of neoadjuvant treatment until death or recurrence of breast cancer disease. |
Inclusion Criteria (must meet all):
Exclusion Criteria:
Individual participants will be discontinued from the trial, in agreement with their physician where appropriate, if any health problem arises that will significantly affect their safety to participate in exercise for more than one month or if the participant decides to withdraw their consent.
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| Name | Affiliation | Role |
|---|---|---|
| António Araújo, MD PhD | Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António, Serviço de Oncologia Médica, Porto, Portugal. Oncology Research, UMIB, ICBAS-School of Medicine and Biomedical Sciences, University of Porto, Porto, Portugal. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António | Porto | 4099-001 | Portugal |
The anonymized individual participant data that will support the findings of this study will be available upon justified request to the corresponding author. The request will be analyzed by the research team and by the ethical and data protection committees of the institution.
From the registration of study and for five years after the closure of the study.
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Pathologists who evaluate the pathological response are masked from the study-arm
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| Promotion of Healthy Physical Activity | Behavioral | The short counseling consists of at least one opportunistic talk for promotion of physical activity, taking up to 5 minutes, during the Medical Oncology appointment or during Physical Assessments at T0. It should follow the instructions of the Portuguese Directorate-General of Health, "Short Counselling for the Promotion of Physical Activity", including the delivery of a Physical Activity Guide plus a Auxiliar of Decision or a Plan of Action or Maintenance.[Mendes R, 2020] All patients will receive a Guide about Nutrition for Cancer Patients [Capela AM, 2023] and may be offered Nutritional, Psychological or other additional consultations according to clinical judgement of the Medical Oncologist. |
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Change on physical activity levels, measured by IPAQ-SF questionnaire (or by accelerometer), from T0 to T1 and from T0 to T2.
| From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| Hand grip strength | Change on hand grip strength, from T0 to T1 and from T0 to T2. | From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| Timed Up and Go | Change on "Timed Up and Go", from T0 to T1 and from T0 to T2. | From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| Complete pathologic response rate | Percentage of participants of each arm that achieved complete pathological response, as assessed by a dedicated pathologist from our institution, blinded for the intervention. | From 1 month up to 2 months after breast surgery. Data can be restropectively collected from the pathologic report after this period. |
| Compliance to intervention | Rate of participants that accepted to participate, that completed intervention, and the percentage of programed exercise sessions that were completed ", at T0, T1 and T2. | From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| Safety | Reported adverse events potentially related to exercise. | From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| Compliance to questionnaires | Rate of participants who replied to the quality of life and fatigue questionnaires, at T0, T1 and T2. | From enrolement to up to 2 months after the end of intervention period, i.e. after breast surgery |
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months |
| Overall survival | Time from the beginning of neoadjuvant treatment until death. | From date of randomization until the date of death from any cause, assessed up to 120 months |
| Health costs | Health costs estimation based on number of emergency episodes, in-hospital days, delayed day hospital sessions, off-labor days. | From enrolement up to 6 months after surgery. |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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