Clinical trial NCT05843539: Adverse Childhood Experiences, Adaptation and Breast Cancer
Official title: Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adverse Childhood Experiences
Cancer, Breast
Attachment Styles
Resilience, Psychological
Quality of Life
Epigenesis, Genetic
Keywords: Breast Cancer
ACEs
Quality of Life
Lead sponsor: University of Lorraine
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2023-05-06
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


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

Primary outcomes:
measure: Quality of life of women in remission from breast cancer
timeFrame: Baseline. Through study completion, an average of 1 year.
Secondary outcomes:
measure: Fear of recurrence
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Fatigue
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Anxiety and Depression
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Attachment
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Adverse Childhood Experiences
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Resilience
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: RMSSD values
timeFrame: Baseline. Through study completion, an average of 1 year.
Other outcomes:
measure: Stress measurement
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Measurement of epigenetic methylations in relation to childhood adversity
timeFrame: Baseline. Through study completion, an average of 1 year.
Locations:
city: Metz
country: France
facility: Ur 4360 Apemac
state: Lorraine
Study officials:
affiliation: UR 4360 APEMAC, University of Lorraine
name: Marion Trousselard, Pr
role: PRINCIPAL_INVESTIGATOR
References: