Clinical trial NCT04379908: Healthy Lifestyles and Quality of Life in Women With Breast Cancer
Official title: Healthy Lifestyles and Quality of Life in Women With Breast Cancer (Health-EpiGEICAM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Lifestyle
Quality of life
Breast cancer
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Asociación Española contra el Cáncer
First posted: 2020-05-08
Enrollment: 801
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer who have previously participated in the epiGEICAM-01 study.

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).

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).

Exclusion Criteria: None

Primary outcomes:
measure: Degree of adherence of breast cancer survivors to international guidelines regarding modifiable lifestyles by questionnaires
timeFrame: After completing the survey, an average of 1 week
measure: Quantify changes in modifiable lifestyles by questionnaires
timeFrame: After completing the survey, an average of 1 week
measure: Differences in adherence to recommendations of survivors of breast cancer
timeFrame: After completing the survey, an average of 1 week
measure: Estimate the health-related quality of life (HRQL) of these patients in all its dimensions and compare it with that observed in the general population and with the self-reported by these women at the time of diagnosis
timeFrame: After completing the survey, an average of 1 week
measure: Adherence effect to the WCRF, AICR and CECC4 recommendations on the HRQL
timeFrame: After completing the survey, an average of 1 week
measure: Compliance effect to the WCRF, AICR and CECC4 recommendations on survival of these women.
timeFrame: After completing the survey, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC)
state: Galicia
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Alicante
country: Spain
facility: Hospital Universitario Virgen de los Lirios
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Gerona
country: Spain
facility: ICO de Girona, Hospital Dr. Josep Trueta
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaén
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Universitario Virgen de la Salud
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Instituto de Salud Carlos III
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital General Universitario Gregorio Marañón
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.