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

NCT ID: NCT06866093

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Breast Cancer; Body Weight Change

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Lifestyle

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Livia S Augustin

Nutrition Researcher, PhD S.C. Epidemiologia e Biostatistica

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Cancer Institute Foundation G. Pascale of Naples

Naples, , Italy

Countries

Italy

Other Identifiers

44/22

Identifier Type: -

Identifier Source: org_study_id