Trials / Completed
CompletedNCT04379908
Healthy Lifestyles and Quality of Life in Women With Breast Cancer
Healthy Lifestyles and Quality of Life in Women With Breast Cancer (Health-EpiGEICAM)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 801 (actual)
- Sponsor
- Spanish Breast Cancer Research Group · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A cross-sectional, multicenter, and observational study designed to update clinical, pathological, and lifestyle information for a cohort of approximately 1245 breast cancer patients included in the epiGEICAM-01 study.
Detailed description
In 2007, GEICAM started the EpiGEICAM case-control study, to investigate the association of diet and other lifestyle factors with breast cancer risk. In this study, we were able to identify two dietary patterns related with breast cancer in an opposite way. Thus, while women with high adherence to the so-called "Western" diet had an excess risk of breast cancer, high adherence to the "Mediterranean" pattern reduced the risk of breast cancer, being this effect particularly marked for triple negative tumors. Regarding physical activity, our preliminary results show a positive association between sedentarism and breast cancer risk. This project will focus on breast cancer patients included in that study in order to explore their degree of adherence to lifestyle behaviour recommendations and their association with the quality of life of these women. Survivors will be re-surveyed to assess tobacco, alcohol, diet, obesity and health-related quality of life, using a specific questionnaire witch contains the following information: * Sociodemographic information. * Anthropometric data (weight, height). * Clinical and gynecological data. * Assessment of lifestyle habits: including tobacco consumption and diet. * Physical activity questionnaire, with the International Physical Activity Questionnaire (IPAQ). * Questionnaire to know the preference of patients on receiving information about their treatment in physical exercise. * General Short Form-36 (SF36) quality of life questionnaire already used at the time of diagnosis. * Specific Fatigue and Quality of Life Questionnaires: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) and Functional Assessment of Cancer Therapy - Fatigue (FACT-F). * Coping questionnaires: COPE-28 and Brief Resilience Scale (BRS).
Conditions
Timeline
- Start date
- 2017-11-07
- Primary completion
- 2019-04-04
- Completion
- 2019-04-04
- First posted
- 2020-05-08
- Last updated
- 2023-03-15
Locations
18 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04379908. Inclusion in this directory is not an endorsement.