The Study is Observational and Retrospective: Lifestyle, BMI and Activity Physical.

NCT06866093 | Active Not Recruiting

• 1 other identifier: 44/22
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational-retrospective study is to learn about the long-term effects of a lifestyle intervention inclusive of dietary counselling and physical activity advice, on body weight in female breast cancer survivors who took the intervention in previous years compared to those who did not take it. The main question it aims to answer is: Does a long-term lifestyle intervention help to control body weight 5 years after breast cancer diagnosis? Participants are asked to answer online survey questions about their anthropomethry, clinical conditions, socio-economical status, dietary habits, physical activity levels, quality of life, sleep quality and pshycological distress.

Conditions

Breast Cancer; Body Weight Change

Keywords

Lifestyle study

Outcome Measures

Primary Outcomes (2)

• Measurement of body weight in kilograms

  The primary objective of the study is to evaluate whether an integrated lifestyle cancer treatment (L-INT) with nutritional and physical activity counseling, within the first year of diagnosis of histologically confirmed primary breast cancer, can result in better control of body weight (measured as BMI classes) after 5 years from diagnosis compared to those who had not adhered to integrated lifestyle treatments (no-INT).

  Baseline

• Measurement of body height in meters

  The primary objective of the study is to evaluate whether an integrated lifestyle cancer treatment (L-INT) with nutritional and physical activity counseling, within the first year of diagnosis of histologically confirmed primary breast cancer, can result in better control of body weight (measured as BMI classes) after 5 years from diagnosis compared to those who had not adhered to integrated lifestyle treatments (no-INT).

  Baseline

Secondary Outcomes (4)

• Units on a Scale adherence to the Mediterranean diet.

  Baseline

• Units on a Scale moderate physical activity.

  Baseline

• Units on a Scale the microbiome of breast tissue

  Baseline

• Units on a Scale of questionnaries quality of life

  Baseline

Study Arms (1)

Lifestyle

The cohort incluedes women (N=428) with a 5-year primary diagnosis of breast cancer eligible to participate in a diet and exercise trial (DEDiCa) in the previous years. Half of them actively participated in the trial and half did not for reasons other than health related issues. Those who consent to participate to the current observational study completed a series of questionnaires.

Other: Lifestyle

Interventions

Lifestyle OTHER

Participants are asked to answer online survey questions about their anthropomethry, clinical conditions, socio-economical status, dietary habits, physical activity levels, quality of life, sleep quality and pshycological distress.

Lifestyle

Eligibility Criteria

• Age: 30 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with a 5-year diagnosis of breast cancer, living in Italy and followed up in the participating hospitals.

You may qualify if:

• Surgery for primary breast cancer performed at least 5 years prior to the interview.
• Women who have joined the DEDiCa trial or who have refused to participate for reasons not related to serious health conditions or disease progression.
• Those who are able to sign the informed consent.

You may not qualify if:

• Age \<30 years.
• Primary diagnosis of metastatic breast cancer.
• Diagnosis of other malignancies prior to the diagnosis of breast cancer.
• Those who are unable to sign the informed consent or who deny to be contacted by telephone.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

IRCCS Cancer Institute Foundation G. Pascale of Naples

Naples, 80131, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

An exploratory secondary objective of the study, in a subset of the sample (N=40), includes an investigation of the microbiome of the breast tissue extracted during breast cancer surgery. This analysis is useful to determine breast cancer tissue microbiome and potential associations with different lifestyle.

MeSH Terms

Conditions

Breast Neoplasms; Body Weight Changes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutrition Researcher, PhD S.C. Epidemiologia e Biostatistica

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 10, 2025
• Study Start: September 4, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)