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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Body Weight Change
• Intervention / Treatment: Other: Lifestyle

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • IRCCS Cancer Institute Foundation G. Pascale of Naples

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Units on a Scale adherence to the Mediterranean diet.	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.	Baseline
Units on a Scale moderate physical activity.	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.	Baseline
Units on a Scale the microbiome of breast tissue	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.	Baseline
Units on a Scale of questionnaries quality of life	The study aim on quality of life including psychological distress, quality of sleep and economic sustainability of the disease.	Baseline

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Lifestyle study
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Body Weight; Breast Neoplasms; Body Weight Changes
• Other Study ID Numbers: 44/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No