NCT06866093

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

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.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 30 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-04
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: Italy