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Healthy Lifestyles and Quality of Life in Women With Breast Cancer

S

Spanish Breast Cancer Research Group (GEICAM)

Status

Completed

Conditions

Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04379908
Health-EpiGEICAM

Details and patient eligibility

About

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.

Full 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).

Enrollment

801 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Women who participated in the case cohort in the epiGEICAM-01 clinical epidemiological study
  • Capable and willing women to provide their written informed consent. If the patient has died, the biological sample and clinical data may be analyzed in those cases in which there is no express opposition from the patient or her relatives for participation in this type of study. The document of previous instructions will be consulted and, failing that, the criteria of the closest relative of the deceased will be recorded.
  • Capable and willing women to complete the questionnaires provided in the study (except deceased).

Exclusion Criteria: None

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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