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

NCT06073418 | Recruiting

• 1 other identifier: CRO-2022-30
• Study Type: observational
• Target: 1,098
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

  At baseline and at 3-5 years of follow up

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

  Frequency of different answers at dietary habits questionnaire

  At baseline and at 3-5 years of follow up

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

  Frequency of different answers at activity questionnaire

  At baseline and at 3-5 years of follow up

Secondary Outcomes (9)

• Association between nutritional knowledge and physical activity

  At baseline and at 3-5 years of follow up

• Association between nutritional knowledge and dietary habits

  At baseline and at 3-5 years of follow up

• Association between dietary habits and physical activity

  At baseline and at 3-5 years of follow up

• Association between dietary habits and BMI

  At baseline and at 3-5 years of follow up

• Association between dietary habits and waist to hip ratio

  At baseline and at 3-5 years of follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordonone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mattia Garutti, MD

  IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattia Garutti, MD

CONTACT

0434 659092; mattia.garutti@cro.it

Giulia Cudia, MSc

CONTACT

giulia.cudia@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: October 10, 2023
• Study Start: October 28, 2022
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

IT (1)