Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06866093

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

30 year–74 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Cancer Institute Foundation G. Pascale of Naples

Naples, 80131, Italy

About this study

Investigators will use data from 428 women with a 5-yr primary diagnosis of BC (stages I-III at ages ≥30 <75 anni). Half of this sample (N=214) who followed integrated lifestyle treatment of behavioral modification of diet and physical activity conducted by Pascale Institute since 2016; the other half (N=214) will be patients who were eligible to participate but did not for logistic reasons.

The present study aims to enroll 428 women with prior primary diagnosis of breast cancer. Half of the patients (N = 214) had previously followed the lifestyle treatment of DEDiCa trial on the modification of eating and physical activity habits (Eudract n. 2015-005147-14) conducted by the Oncologic Institute Pascale in Naples (Italy) since Nov 2016; the other half of the patients were 214 who had refused to participate in the aforementioned trial for reasons unrelated to serious health conditions or progression of the disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Measurement of body weight in kilograms

    Time frame: 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).

  2. Measurement of body height in meters

    Time frame: 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).

Secondary outcomes

  1. Units on a Scale adherence to the Mediterranean diet.

    Time frame: Baseline

    The secondary objectives aim to evaluate the current adherence to the Mediterranean diet and the following variables: disease-free survival, new onset of chronic diseases (second cancer, diabetes, cardiovascular events, osteoporosis/bone fractures), quality of life including psychological distress and sleep quality. As an exploratory secondary objective, on a subgroup (N = 40), plans to study the microbiome of breast cancer tissue stored in the biobank of the Pascale Institute, to relate it to the characteristics of the disease and the patients' lifestyle.

  2. Units on a Scale moderate physical activity.

    Time frame: Baseline

    The secondary objectives of study is moderate physical activity, together at the association between current adherence to the Mediterranean diet and the following variables: current body weight (BMI), disease-free survival, new onset of chronic diseases (second cancer, diabetes, cardiovascular events, osteoporosis/bone fractures), quality of life including psychological distress, quality of sleep and economic sustainability of the disease.

  3. Units on a Scale the microbiome of breast tissue

    Time frame: Baseline

    As a secondary exploratory and innovative objective, on a subgroup (N=40), we plan to study the microbiome of the breast tissue stored in the biobank of the Pascale Institute, to relate it to the characteristics of the disease and the patient.

  4. Units on a Scale of questionnaries quality of life

    Time frame: Baseline

    The study aim on quality of life including psychological distress, quality of sleep and economic sustainability of the disease.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

Evaluation of the Long-term Effect of Integrated Lifestyle Treatments on Dietary Habits, Sedentary Behavior, Anthropometry, Quality of Life in Female Breast Cancer Survivors, Through Traditional and Innovative Statistical Methods.

Acronym: Lifestyle

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.