About this trial
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 complement the currently available treatment options. In particular, interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, and improve survival and the quality of life.This cross-sectional, prospective, observational study aims at evaluating dietary habits and nutritional knowledge in patients with early hormone receptor positive and hormone receptor negative breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with surgically removed early stage (I-IIIa) hormone receptor-positive or hormone receptor negative breast cancer. Patients with hormone receptor-positive breast cancer can be in treatment with endocrine therapy; patients with hormone receptor-negative tumors have to be in follow-up. Concomitant use of targeted therapies with anti-hormonal agents is allowed only in adjuvant setting
Female patients ≥18 years of age.
Written informed consent must be obtained before any study-related assessment is performed
Disqualifiers
Patients with advanced/metastatic breast cancer.
Patients with early breast cancer receiving (neo)adjuvant chemotherapy or anti-HER2 agents
Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias)
Trial population
All patients with early stage hormone receptor positive breast cancer treated at the Department of Medical Oncology and Cancer Prevention, IRCCS National Cancer Institute of Aviano and at the other involved clinical centers considered eligible for the study will be enrolled, after providing written informed consent.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Evaluation of nutritional knowledge in patients with surgically removed early breast cancer
Median and interquartile range of items of nutritional knowledge questionnaire in patients with surgically removed early breast cancer
Evaluation of dietary habits in patients with surgically removed early breast cancer
Frequency of different answers at dietary habits questionnaire
Evaluation of physical activity in patients with surgically removed early breast cancer
Frequency of different answers at activity questionnaire
Secondary outcomes
Association between nutritional knowledge and physical activity
difference in nutritional knowledge score between subgroups of patients with different levels of physical activity
Association between nutritional knowledge and dietary habits
difference in nutritional knowledge score between subgroups of patients with different frequencies of consumption for selected foods
Association between dietary habits and physical activity
association between frequencies of consumption for selected foods and levels of physical activity
Association between dietary habits and BMI
Difference in frequencies of consumption for selected foods between BMI categories
Sponsors and contacts
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