Adverse Childhood Experiences, Adaptation and Breast Cancer (CAPONE)

August 16, 2023 updated by: Christine Rotonda, University of Lorraine

Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of women in remission from breast cancer
Time Frame: Baseline. Through study completion, an average of 1 year.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of recurrence
Time Frame: Baseline. Through study completion, an average of 1 year.
The level of fear of cancer recurrence as assessed by the Cancer Recurrence Fear Inventory
Baseline. Through study completion, an average of 1 year.
Fatigue
Time Frame: Baseline. Through study completion, an average of 1 year.
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.
Anxiety and Depression
Time Frame: Baseline. Through study completion, an average of 1 year.

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.
Attachment
Time Frame: Baseline. Through study completion, an average of 1 year.
Attachment relationships were assessed using the Relationship Scales Questionnaire (RSQ).
Baseline. Through study completion, an average of 1 year.
Adverse Childhood Experiences
Time Frame: Baseline. Through study completion, an average of 1 year.

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.
Resilience
Time Frame: Baseline. Through study completion, an average of 1 year.
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.
RMSSD values
Time Frame: Baseline. Through study completion, an average of 1 year.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress measurement
Time Frame: Baseline. Through study completion, an average of 1 year.
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.
Measurement of epigenetic methylations in relation to childhood adversity
Time Frame: Baseline. Through study completion, an average of 1 year.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lorraine

Collaborators

Ligue contre le cancer, France

Investigators

  • Principal Investigator: Marion Trousselard, Pr, UR 4360 APEMAC, UNIVERSITY OF LORRAINE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A02850-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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