Adverse Childhood Experiences, Adaptation and Breast Cancer

Quality of Life Clinical Trial

— CAPONE  

Official title:

Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843539
• Other study ID #: 2021-A02850-36
• Status: Recruiting
• Start date: April 12, 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: University of Lorraine
• Contact: Marion Trousselard, Pr
• Phone: 06 44 06 66 37
• Email: marion.trousselard[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Breast Neoplasms
• Cancer, Breast
• Quality of Life
• Resilience, Psychological

Intervention

Genetic:
• 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.

Locations

Country	Name	City	State
France	Ur 4360 Apemac	Metz	Lorraine

Sponsors (2)

Lead Sponsor	Collaborator
University of Lorraine	Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stress measurement	Hair cortisol levels via analysis of 100 hairs collected with the root and stored at 4°C	Baseline. Through study completion, an average of 1 year.
Other	Measurement of epigenetic methylations in relation to childhood adversity	Percentage methylation of genes coding for directed analysis of target regions coding for NR3C1 and FKBP5 genes derived from whole blood, saliva and oral cells assessed using chromatin immunoprecipitation (ChIP) assays	Baseline. Through study completion, an average of 1 year.
Primary	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	Fear of recurrence	The level of fear of cancer recurrence as assessed by the Cancer Recurrence Fear Inventory	Baseline. Through study completion, an average of 1 year.
Secondary	Fatigue	Level of fatigue assessed by the Multidimensional Fatigue Inventory (MFI). It is a questionnaire with 20 items on a 5-point likert scale ranging from 1 "strongly disagree" (worth 1 point) to 5 "strongly agree" (worth 5 points). The score is calculated by summing the points on the scale. The higher the score, the more severe the fatigue.	Baseline. Through study completion, an average of 1 year.
Secondary	Anxiety and Depression	Level of anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS).; This scale evaluates the level of anxiety in 7 items and the level of depression in 7 items, ranging from 0 to 3. A score greater than or equal to 10 indicates a definite level of anxiety or depression.	Baseline. Through study completion, an average of 1 year.
Secondary	Attachment	Attachment relationships were assessed using the Relationship Scales Questionnaire (RSQ).	Baseline. Through study completion, an average of 1 year.
Secondary	Adverse Childhood Experiences	The number of adverse childhood and adolescent experiences assessed using the Adverse Childhood Experiences International Questionnaire (ACE-IQ).; The total number of ACEs to which the participant has been "exposed" is summed to create an ACE score ranging from 0 (no ACEs) to 13. A score of 0 ACEs means a low level of adversity and a score of 13 means a major level of adversity.	Baseline. Through study completion, an average of 1 year.
Secondary	Resilience	The level of resilience estimated using the Brief Resilience Scale (BRS). The Brief Resilience Scale is a 6-item questionnaire. Each item is rated on a 5-point Likert scale. Higher scores indicate greater resilience.	Baseline. Through study completion, an average of 1 year.
Secondary	RMSSD values	Differences in resting RMSSD (root mean square of successive differences between normal heartbeats) values according to the status with or without ACE, performed via the Caducy (software)	Baseline. Through study completion, an average of 1 year.