Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentro di Riferimento Oncologico - Aviano

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
At baseline and at 3-5 years of follow up
2

Evaluation of dietary habits in patients with surgically removed early breast cancer

Frequency of different answers at dietary habits questionnaire

Time frame
At baseline and at 3-5 years of follow up
3

Evaluation of physical activity in patients with surgically removed early breast cancer

Frequency of different answers at activity questionnaire

Time frame
At baseline and at 3-5 years of follow up

Secondary outcomes

1

Association between nutritional knowledge and physical activity

difference in nutritional knowledge score between subgroups of patients with different levels of physical activity

Time frame
At baseline and at 3-5 years of follow up
2

Association between nutritional knowledge and dietary habits

difference in nutritional knowledge score between subgroups of patients with different frequencies of consumption for selected foods

Time frame
At baseline and at 3-5 years of follow up
3

Association between dietary habits and physical activity

association between frequencies of consumption for selected foods and levels of physical activity

Time frame
At baseline and at 3-5 years of follow up
4

Association between dietary habits and BMI

Difference in frequencies of consumption for selected foods between BMI categories

Time frame
At baseline and at 3-5 years of follow up

Other outcomes

Sponsors and contacts

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