NCT Number: NCT07539038
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).
Interested in participating?
Request Info18 year and older
Female
Observational
Aviano, Pordenone, 33081, Italy
Location status: Recruiting
Fabio Puglisi, MD, PhD
SUB_INVESTIGATOR
Linda Cucciniello, MD
SUB_INVESTIGATOR
Mattia Garutti, MD
CONTACT
Mattia Garutti, MD
PRINCIPAL_INVESTIGATOR
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).
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months after the end of the physical activity program
Mean difference in BMI (Body Mass Index)
Time frame: Up to 6 months after the end of the physical activity program
Mean difference in body measures such as circumferences and plicometry
Time frame: Up to 6 months after the end of the physical activity program
Mean difference in Bioelectrical Impedance Analysis (BIA)
Contact information is provided by the study sponsor or research team.
Centro di Riferimento Oncologico - Aviano
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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