Breast Cancer
Conditions
Brief summary
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life. This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).
Detailed description
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life. This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).
Interventions
None listed
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Patients with early stage (I-IIIa) hormone receptor-positive breast cancer receiving adjuvant endocrine therapy * Female patients ≥18 years of age * Written informed consent must be obtained before any study-related assessment is performed * Participation to the Medicina and Sport physical activity program organized by Andos Pordenone
Exclusion criteria
* Patients with early hormone receptor negative breast cancer * Patients with early hormone receptor positive breast cancer receiving chemotherapy * Patients with advanced/metastatic breast cancer. * Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias). * Patients with history of vertebral and/or femoral fractures * Patients with CVDs not optimally controlled by medical therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire. | Up to 6 months after the end of the physical activity program | Mean differences on the questionnaire will be evaluated. The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item validated tool used to assess the physical, psychological, and social functions of cancer patients. Higher scores on functional scales and the global health status represent a higher/better level of functioning, while higher scores on symptom scales represent a higher level of symptomatology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pain Intensity (Brief Pain Inventory - Short Form) | Up to 6 months after the end of the physical activity program | Pain intensity will be assessed using the Brief Pain Inventory (BPI) Severity score, rated on an 11-point Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). A higher score indicates greater pain intensity. |
| Change from Baseline in Physical Activity Levels | Up to 6 months after the end of the physical activity program | Subjective physical fitness and activity will be evaluated using the IPAQ (International Physical Activity Questionnaire). This questionnaire assesses walking, moderate-intensity, and vigorous-intensity activities. Results are reported as Metabolic Equivalent of Task (MET)-minutes per week. Higher MET-minutes indicate higher physical activity levels. |
| Change from Baseline in Dietary Habits and Nutritional Intake | Up to 6 months after the end of the physical activity program | Evaluated through food diaries provided during nutritional visits. The diaries assess caloric intake and macronutrient distribution (carbohydrates, proteins, fats). |
| Change from Baseline in Blood Test Results | Up to 6 months after the end of the physical activity program | Difference in mean of laboratory parameters as collected during routine nutritional visits to assess the metabolic impact of the program. |
| incidence of Hormonal Therapy-Related Toxicities | Through the end of the program and follow-up (up to 6 months). | Frequencies of side effects and toxicities related to hormonal therapy assessed via clinical examination and patient interview according to CTCAE (Common Terminology Criteria for Adverse Events) or standard clinical practice. |
| Change from Baseline in BMI | Up to 6 months after the end of the physical activity program | Mean difference in BMI (Body Mass Index) |
| Change from Baseline in body measures | Up to 6 months after the end of the physical activity program | Mean difference in body measures such as circumferences and plicometry |
| Change from Baseline in BIA | Up to 6 months after the end of the physical activity program | Mean difference in Bioelectrical Impedance Analysis (BIA) |
Countries
Italy
Contacts
CONTACTMattia Garutti
Outcome results
None listed