Healthy Lifestyles and Quality of Life in Women With Breast Cancer

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT04379908

Acronym / sponsor ID

Health-EpiGEICAM

Conditions

Breast Cancer

Keywords

Lifestyle, Quality of life, Breast cancer

Study type

Observational

Recruitment status

Completed

Enrolment

801 participants (actual)

Lead sponsor

Spanish Breast Cancer Research GroupUniversity, hospital or other

Collaborators

Asociación Española contra el Cáncer

Study start

7 Nov 2017 (actual)

Primary completion

4 Apr 2019 (actual)

Study completion

4 Apr 2019 (actual)

First posted

8 May 2020 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Case only

Time perspective

Cross-sectional

Target follow-up

1 Day

Who may qualify

Ages

18 years and older

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. 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).

2. 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

3. 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).

4. 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.

5. 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).

6. 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
• Results publication: PubMed 36230628Lope 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.
• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research GroupLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

18 sites in 1 country: see every site and its status.