Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Body Weight Change | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Lifestyle
- description
- 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.
- interventionNames
- Other: Lifestyle
Primary outcomes (2)
- measure
- Measurement of body weight in kilograms
- timeFrame
- Baseline
- description
- 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).
- measure
- Measurement of body height in meters
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available