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Active, not recruiting Observational

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

NCT06866093 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-09-04
Last updated
2025-03-10

Condition(s) studied

Breast CancerBody Weight Change

Investigational drug(s) / intervention(s)

Lifestyle

Lifestyle: 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.

Study 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.

Eligibility

Sex
FEMALE
Min age
30 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria: 1. Surgery for primary breast cancer performed at least 5 years prior to the interview. 2. Women who have joined the DEDiCa trial or who have refused to participate for reasons not related to serious health conditions or disease progression. 3. Those who are able to sign the informed consent. Exclusion Criteria: 1. Age \<30 years. 2. Primary diagnosis of metastatic breast cancer. 3. Diagnosis of other malignancies prior to the diagnosis of breast cancer. 4. Those who are unable to sign the informed consent or who deny to be contacted by telephone.

Primary outcome measure(s)

  • Measurement of body weight in kilograms — Baseline
    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).
  • Measurement of body height in meters — Baseline
    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).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Cancer Institute Foundation G. Pascale of Naples Naples Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06866093 on ClinicalTrials.gov ↗ ← All trials in Italy