Healthy Lifestyles and Quality of Life in Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Healthy Lifestyles and Quality of Life in Women With Breast Cancer (Health-EpiGEICAM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379908
• Other study ID #: Health-EpiGEICAM
• Status: Completed
• Start date: November 7, 2017
• Est. completion date: April 4, 2019

Study information

• Verified date: March 2023
• Source: Spanish Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: April 4, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Spain	Centro Oncológico de Galicia	A Coruña
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC)	A Coruña	Galicia
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
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	Gerona
Spain	Complejo Hospitalario de Jaén	Jaen
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Universitario Virgen de la Salud	Toledo
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Instituto Valenciano de Oncología	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group	Asociación Española contra el Cáncer

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of adherence of breast cancer survivors to international guidelines regarding modifiable lifestyles by questionnaires	The scores that measure the degree of compliance with the World Cancer Research Fund (WCRF) / American Institute for Cancer Research (AICR) recommendations and those included in the European Code Against Cancer 4th edition (CECC4) at the time of diagnosis (time 1) and those obtained in the second interview (time 2) will be calculated and described. Differences will be described using basic descriptive statistics and the statistical significance of the differences found using the paired samples hypothesis contrast test (repeated measurements on the same woman). To assess which factors are associated with changes in the degree of compliance, repeated measures mixed models will be used, considering each woman as a term with random effects.; The specific questionnaires that will be used are Anthropometric data, Assessment of lifestyle habits, International Physical Activity Questionnaire (IPAQ).	After completing the survey, an average of 1 week
Primary	Quantify changes in modifiable lifestyles by questionnaires	The scores that measure the degree of compliance with the World Cancer Research Fund (WCRF) / American Institute for Cancer Research (AICR) recommendations and those included in the European Code Against Cancer 4th edition (CECC4) at the time of diagnosis (time 1) and those obtained in the second interview (time 2) will be calculated and described. Differences will be described using basic descriptive statistics and the statistical significance of the differences found using the paired samples hypothesis contrast test (repeated measurements on the same woman). To assess which factors are associated with changes in the degree of compliance, repeated measures mixed models will be used, considering each woman as a term with random effects.; The specific questionnaire that will be used is Assessment of lifestyle habits	After completing the survey, an average of 1 week
Primary	Differences in adherence to recommendations of survivors of breast cancer	The scores that measure the degree of compliance with the World Cancer Research Fund (WCRF) / American Institute for Cancer Research (AICR) recommendations and those included in the European Code Against Cancer 4th edition (CECC4) at the time of diagnosis (time 1) and those obtained in the second interview (time 2) will be calculated and described. Differences will be described using basic descriptive statistics and the statistical significance of the differences found using the paired samples hypothesis contrast test (repeated measurements on the same woman). To assess which factors are associated with changes in the degree of compliance, repeated measures mixed models will be used, considering each woman as a term with random effects.; The specific questionnaires that will be used are Sociodemographic information, Clinical and gynecological data and Coping questionnaires: COPE-28 and Brief Resilience Scale (BRS).	After completing the survey, an average of 1 week
Primary	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	The HRQL will be estimated at the present time and at diagnosis, computing the Short Form-36 Health Survey scores in the 8 dimensions included in the questionnaire and the two summarizing components. To compare the HRQL observed in these women with those of the Spanish population, standardized values of these dimensions will be used, considering the mean and standard deviation observed in the general population. The Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) and the Functional Assessment of Cancer Therapy - Fatigue (FACT-F) questionnaire will be assessed according to the FACT scoring standards.; The higher the number of points, the better the quality of life. To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.	After completing the survey, an average of 1 week
Primary	Adherence effect to the WCRF, AICR and CECC4 recommendations on the HRQL	Adherence effect to recommendations (measuring each of them separately and global adherence) has a positive impact on the HRQL of these women.; Global adherence score to the WCRF / AICR recommendations and to those included in the CECC4 on each of the HRQL dimensions will be quantified, using multiple regression models including age adjustment variables, the time from diagnosis, stage, situation with respect to the tumor (without disease or with disease) and socioeconomic status, as well as all those that act as confounding factors (those that are associated with HRQL and the degree of adherence to the recommendations ). Outcome variable: HRQL dimensions; Main exposure variable: Index of compliance with the recommendations.; The specific questionnaires that will be used are General Short Form-36 quality of life questionnaire, Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) and Functional Assessment of Cancer Therapy - Fatigue (FACT-F).	After completing the survey, an average of 1 week
Primary	Compliance effect to the WCRF, AICR and CECC4 recommendations on survival of these women.	Cox regression models will be used to explore the influence that initial adherence to these recommendations has had on disease-free survival and overall survival for these women. Result variable: Time until the occurrence of the event / censorship; Main exposure variable: Degree of initial compliance with the recommendations.; Disease-free survival is defined as the time from initially diagnosis to the first documented progression disease, or death from any cause, whichever occurs first.; Overall survival is defined as the time from the date of initially diagnosis to the date of death from any cause.	After completing the survey, an average of 1 week

External Links

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