Healthy Lifestyles & Quality of Life in Women With Breast Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04379908
Study type	Observational [Patient Registry]
Source	Spanish Breast Cancer Research Group
Contact
Status	Completed
Phase
Start date	November 7, 2017
Completion date	April 4, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Healthy Lifestyles and Quality of Life in Women With Breast Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms