Clinical trial NCT06866093: The Study is Observational and Retrospective: Lifestyle, BMI and Activity Physical.
Official 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.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Body Weight Change
Keywords: Lifestyle study
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 112
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Measurement of body weight in kilograms
timeFrame: Baseline
measure: Measurement of body height in meters
timeFrame: Baseline
Secondary outcomes:
measure: Units on a Scale adherence to the Mediterranean diet.
timeFrame: Baseline
measure: Units on a Scale moderate physical activity.
timeFrame: Baseline
measure: Units on a Scale the microbiome of breast tissue
timeFrame: Baseline
measure: Units on a Scale of questionnaries quality of life
timeFrame: Baseline
Other outcomes:
Locations:
city: Naples
country: Italy
facility: IRCCS Cancer Institute Foundation G. Pascale of Naples
Study officials:
References: