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The main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.
BACKGROUND/MAIN OBJECTIVE: The main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours. As secondary objectives we aim to assess whether the proposed intervention is able to improve the overall survival or the disease-free survival, as well as quality of life of breast cancer patients. METHODOLOGY: This multicentric randomized controlled trial aims to include 2108 women (1054 per arm), aged up to 75 years, diagnosed with a non-metastatic breast cancer (stage I, II, IIIA) in the participating centres, whose standard treatment was completed within the last 3 months. Participants will be assigned to either an intervention or a control group, and followed for five years. Patients assigned to the control arm will continue with the usual care, including standard guidelines for weight control applied in the centre. Patients in the intervention group will be involved in a lifestyle program with two components. The dietary part will aim to achieve a calorie reduction while maintaining nutritional quality; the physical activity part will include supervised sessions of moderate intensity. Data will be analyzed on an intention to treat basis using time-toevent analysis. HYPOTHESES: We expect a significant reduction in the 5-year cumulative incidence of recurrences (primary outcome) in the intervention group. Furthermore, as secondary outcomes, we expect a significant increase in overall survival and an improvement of quality of life of patients included in the intervention arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Lifestyle intervention combining weight control, diet and physical activity |
|
| Minimal intervention | Sham Comparator | Minimal diet intervention and minimal physical activity intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Behavioral | The dietary component, aimed to reduce calorie intake according to individual requirements, will be structured in 1-hour weekly sessions led by trained nutritionists. Sessions will concentrate on teaching participants about food groups, the food pyramid and Mediterranean diet, how to chose, prepare and cook hypo-caloric meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to local and distant recurrence | Time between recruitment date and local and distant recurrence date or end of the 5-year follow-up which ever occurs first | 5 years from recruitment day |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time between recruitment date and death date or end of 5-year follow-up which ever occurs first | 5 years |
| Disease free survival | Time between recruitment date and recurrence (local or distant) or death or end of 5-year follow-up which ever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in biomarkers | Biomarkers related to:
| Baseline and one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Agudo, MD-PhD | Contact | +34 932607401 | a.agudo@iconcologia.net | |
| Noemie Travier, MSc | Contact | +34 932607401 | ntravier@iconcologia.net |
| Name | Affiliation | Role |
|---|---|---|
| Beatriz Cirauqui Cirauqui, MD | Fundació Institut d'Investigació Germans Trias i Pujol | Principal Investigator |
| Sonia Del Barco Berron, MD | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Institut d'Investigació Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
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|
| Physical activity | Behavioral | The physical activity component will include two sessions per week led by trained physical activity monitors including aerobic exercise of high/moderate intensity, and instruction about the at-home exercise activities (3 more sessions). |
|
| Minimal diet intervention | Behavioral | Some basic diet recommendations |
|
| Minimal physical activity intervention | Behavioral | Some basic recommendations on physical activity |
|
| 5 years |
| Quality of life | Quality of life assessments using the SF36, the FACIT (fatigue questionnaire) and the HADS (Anxiety and depression) | Baseline, one year and three years |
| Vanesa Ortega Cebrián, MD | Hospital Vall d'Hebron | Principal Investigator |
| Maria Angeles Arcusa Lanza, MD | Consorci Sanitari de Terrassa | Principal Investigator |
| Antonio Agudo, MD | Institut Català d'Oncología - L'Hospitalet (ICO) | Principal Investigator |
| Hospital Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain |
|
| Institut Catala d'Oncologia - L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
|
| Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
|
| Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | Girona | Girona | 17003 | Spain |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012008 | Recurrence |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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