Healthy Lifestyles and Quality of Life in Women With Breast Cancer

March 13, 2023 updated by: Spanish Breast Cancer Research Group

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

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

801

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15009
        • Centro Oncológico de Galicia
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Alicante, Spain, 03804
        • Hospital Universitario Virgen de los Lirios
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Cadiz, Spain, 11009
        • Hospital Puerta del Mar
      • Gerona, Spain, 17007
        • ICO de Girona, Hospital Dr. Josep Trueta
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaén
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Toledo, Spain, 45071
        • Hospital Universitario Virgen de La Salud
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Mutua De Terrassa
      • Terrassa, Barcelona, Spain
        • Consorci Sanitari de Terrassa
    • Galicia
      • A Coruña, Galicia, Spain
        • Complejo Hospitalario Universitario A Coruña (CHUAC)
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion ALcorcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of adherence of breast cancer survivors to international guidelines regarding modifiable lifestyles by questionnaires
Time Frame: After completing the survey, an average of 1 week

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
Time Frame: After completing the survey, an average of 1 week

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
Time Frame: After completing the survey, an average of 1 week

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
Time Frame: After completing the survey, an average of 1 week

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
Time Frame: After completing the survey, an average of 1 week

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.
Time Frame: After completing the survey, an average of 1 week

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Breast Cancer Research Group

Collaborators

Asociación Española contra el Cáncer

Investigators

  • Study Director: Study Director, Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2017

Primary Completion (Actual)

April 4, 2019

Study Completion (Actual)

April 4, 2019

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Health-EpiGEICAM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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