Adverse Childhood Experiences, Adaptation and Breast Cancer

NCT05843539 | Completed DMC

• 1 other identifier: 2021-A02850-36
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Breast Cancer; ACEs; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of life of women in remission from breast cancer

  The primary outcome was quality of life assessed with the Short Form Survey 12 (SF-12 scale). The score ranges from 0 to 100, with a score above 50 indicating average quality of life, 40 to 49 indicating mild disability, 30 to 39 indicating moderate disability, and below 30 indicating severe disability.

  Baseline. Through study completion, an average of 1 year.

Secondary Outcomes (7)

• Fear of recurrence

  Baseline. Through study completion, an average of 1 year.

• Fatigue

  Baseline. Through study completion, an average of 1 year.

• Anxiety and Depression

  Baseline. Through study completion, an average of 1 year.

• Attachment

  Baseline. Through study completion, an average of 1 year.

• Adverse Childhood Experiences

  Baseline. Through study completion, an average of 1 year.

Other Outcomes (2)

• Stress measurement

  Baseline. Through study completion, an average of 1 year.

• Measurement of epigenetic methylations in relation to childhood adversity

  Baseline. Through study completion, an average of 1 year.

Interventions

Biological and epigenetic measures GENETIC

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lorraine: lead
• Ligue contre le cancer, France: collaborator

Study Sites (1)

Ur 4360 Apemac

Metz, Lorraine, 57000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study also includes a biological ancillary study exploring sub-cellular mechanisms, using high-throughput sequencing to identify gene expression variations that are determinant in terms of vulnerability/protection (cytogenetics and transcriptome). The objective of the ancillary study, coupled to the main study, is 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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Marion Trousselard, Pr

  UR 4360 APEMAC, University of Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the research pole in Pierre Janet Center

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 6, 2023
• Study Start: April 12, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)