Healthy Lifestyles and Quality of Life in Women With Breast Cancer

NCT04379908 | Completed

• 1 other identifier: Health-EpiGEICAM
• Study Type: observational
• Target: 801
• Locations: 1 country
• Sites: 18

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.

Conditions

Breast Cancer

Keywords

Lifestyle; Quality of life; Breast cancer

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer who have previously participated in the epiGEICAM-01 study.

You may qualify if:

• 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).

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Asociación Española contra el Cáncer: collaborator

Study Sites (18)

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Galicia, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Centro Oncológico de Galicia

A Coruña, 15009, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario Virgen de los Lirios

Alicante, 03804, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

ICO de Girona, Hospital Dr. Josep Trueta

Girona, 17007, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario Virgen de la Salud

Toledo, 45071, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related 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, 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.

  PMID: 36230628 RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Samples of stored primary tumor tissue will be collected (if available) in order to obtain high-quality molecular data to gain a better understanding of breast cancer.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Instituto de Salud Carlos III

  STUDY DIRECTOR

• Study Director

  Hospital General Universitario Gregorio Marañón

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 8, 2020
• Study Start: November 7, 2017
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

ES (18)