Healthy Lifestyles and Quality of Life in Women With Breast Cancer

NCT ID: NCT04379908

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 801 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2019-04-04

Brief 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

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Asociación Española contra el Cáncer

OTHER

Sponsor Role: collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Instituto de Salud Carlos III

Study Director

Role: STUDY_DIRECTOR

Hospital General Universitario Gregorio Marañón

Locations

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Galicia, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Centro Oncológico de Galicia

A Coruña, , Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Universitario Virgen de los Lirios

Alicante, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital Universitario de Burgos

Burgos, , Spain

Hospital Puerta del Mar

Cadiz, , Spain

ICO de Girona, Hospital Dr. Josep Trueta

Girona, , Spain

Complejo Hospitalario de Jaén

Jaén, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Universitario Virgen de la Salud

Toledo, , Spain

Instituto Valenciano de Oncología

Valencia, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

Lope V, Guerrero-Zotano A, Ruiz-Moreno E, Bermejo B, Antolin S, Montano A, Baena-Canada JM, Ramos Vazquez M, Fernandez de Larrea-Baz N, Chacon JI, Garcia-Saenz JA, Olier C, Munoz M, Anton A, Sanchez Rovira P, Arcusa Lanza A, Gonzalez S, Oltra A, Brunet J, Gavila Gregori J, Martinez MT, Calvo L, Rosell L, Bezares S, Pastor-Barriuso R, Perez-Gomez B, Martin M, Pollan M. Clinical and Sociodemographic Determinants of Adherence to World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Recommendations in Breast Cancer Survivors-Health-EpiGEICAM Study. Cancers (Basel). 2022 Sep 27;14(19):4705. doi: 10.3390/cancers14194705.

Reference Type: RESULT

PMID: 36230628 (View on PubMed)

Related Links

http://www.geicam.org

Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Other Identifiers

Health-EpiGEICAM

Identifier Type: -

Identifier Source: org_study_id