An observational study in Breast Cancer, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Centro di Riferimento Oncologico - Aviano · Observational
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).
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).
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 44 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centro di Riferimento Oncologico - Aviano is the lead sponsor of 51 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Early stage hormone receptor positive breast cancer patients participating to the Medicina and Sport
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire.
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.
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in Pain Intensity (Brief Pain Inventory - Short Form)
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.
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in Physical Activity Levels
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.
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in Dietary Habits and Nutritional Intake
Evaluated through food diaries provided during nutritional visits. The diaries assess caloric intake and macronutrient distribution (carbohydrates, proteins, fats).
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in Blood Test Results
Difference in mean of laboratory parameters as collected during routine nutritional visits to assess the metabolic impact of the program.
Time frame: Up to 6 months after the end of the physical activity program
incidence of Hormonal Therapy-Related Toxicities
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.
Time frame: Through the end of the program and follow-up (up to 6 months).
Change from Baseline in BMI
Mean difference in BMI (Body Mass Index)
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in body measures
Mean difference in body measures such as circumferences and plicometry
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in BIA
Mean difference in Bioelectrical Impedance Analysis (BIA)
Time frame: Up to 6 months after the end of the physical activity program
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Centro di Riferimento Oncologico - Aviano