Clinical trial

Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer

Name
2021-A02850-36
Description
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.
Trial arms
Trial start
2022-04-12
Estimated PCD
2023-06-30
Trial end
2023-12-01
Status
Recruiting
Treatment
Biological and epigenetic measures
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.
Size
128
Primary endpoint
Quality of life of women in remission from breast cancer
Baseline. Through study completion, an average of 1 year.
Eligibility 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
Protocol
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Updated at
2023-08-21

1 organization

1 product

9 indications

Indication
Cancer
Indication
Breast
Indication
Resilience
Indication
Mental health
Indication
Quality of Life
Indication
Epigenesis
Indication
Genetic