Adverse Childhood Experiences, Adaptation and Breast Cancer

Trial Title: Adverse Childhood Experiences, Adaptation and Breast Cancer

NCT ID: NCT05843539

Condition: Adverse Childhood Experiences
Cancer, Breast
Attachment Styles
Resilience, Psychological
Quality of Life
Epigenesis, Genetic

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast Cancer
ACEs
Quality of Life

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Genetic
Intervention name: Biological and epigenetic measures
Description: This study also includes an exploratory biological ancillary study that aims to identify the gene expression variations that are determinant in terms of vulnerability/protection (cytogenetic and transcriptome), through the measurement of the level of biological chronic stress and epigenetic methylations of the NR3C1 and FKBP5 genes, in relation to adversity in childhood And to show the convergence between self-reported measures related to the presence of ACEs and attachment disorders with assays of chronic stress and epigenetic biomarkers.

Summary: Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase. ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications. The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.

Criteria for eligibility:

Study pop:
The population studied in this research is a group of adult women who have had breast cancer and are in remission, i.e. whose symptoms and clinical signs visible on medical imaging have diminished or disappeared after treatment for the cancer.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Have had breast cancer - Be considered in remission - Be over 18 years of age - Literate (able to understand the information and complete the questionnaire independently) - Agree to participate in the project and sign the informed consent form Exclusion Criteria: - Be a person subject to a legal protection measure - Be a protected adult, under guardianship or curators - Be undergoing oncological treatment - Have a lack of autonomy making it impossible to complete the questionnaire online - Have had or have begun psychotherapeutic treatment

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ur 4360 Apemac

Address:
City: Metz
Zip: 57000
Country: France

Status: Recruiting

Contact:
Last name: Marion Trousselard, PR

Phone: 06 44 06 66 37
Email: marion.trousselard@intradef.gouv.fr

Contact backup:
Last name: Christine Rotonda, PhD

Phone: 03 72 74 82 26
Email: christine.rotonda@univ-lorraine.fr

Start date: April 12, 2022

Completion date: December 2023

Lead sponsor:
Agency: University of Lorraine
Agency class: Other

Collaborator:
Agency: Ligue contre le cancer, France
Agency class: Other

Source: University of Lorraine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05843539