Adverse Childhood ExperiencesCAPONENCT05843539
Adverse Childhood Experiences, Adaptation and Breast Cancer
An observational study of Adverse Childhood Experiences and Cancer, Breast, run by University of Lorraine at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adverse Childhood Experiences, Cancer, Breast, Attachment Styles
- What is being tested?
- Biological and epigenetic measures
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Adverse Childhood Experiences, Cancer, Breast, Attachment Styles, Resilience, Psychological, Quality of Life, Epigenesis, Genetic
- Being tested
- Biological and epigenetic measures
- Keywords
- Breast Cancer, ACEs, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological and epigenetic measuresGenetic
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline. Through study completion, an average of 1 year.
Secondary outcomes (7)
Fear of recurrence
The level of fear of cancer recurrence as assessed by the Cancer Recurrence Fear Inventory
Measured: Baseline. Through study completion, an average of 1 year.
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.
Measured: Baseline. Through study completion, an average of 1 year.
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.
Measured: Baseline. Through study completion, an average of 1 year.
Attachment
Attachment relationships were assessed using the Relationship Scales Questionnaire (RSQ).
Measured: Baseline. Through study completion, an average of 1 year.
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.
Measured: Baseline. Through study completion, an average of 1 year.
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.
Measured: Baseline. Through study completion, an average of 1 year.
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)
Measured: Baseline. Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start12 Apr 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Principal investigator, Christine Rotonda, University of Lorraine
- Investigators
- Marion Trousselard, Pr, Principal investigator, UR 4360 APEMAC, University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843539
- Sponsor's protocol ID
- 2021-A02850-36
- Acronym
- CAPONE
- Status last verified
- Jul 2025
- First submitted
- 16 Mar 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer
- ClinicalTrials.gov ID
- NCT05843539
- Acronym / sponsor ID
- CAPONE / 2021-A02850-36
- Conditions
- Adverse Childhood Experiences, Cancer, Breast, Attachment Styles, Resilience, Psychological, Quality of Life, Epigenesis, Genetic
- Keywords
- Breast Cancer, ACEs, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological and epigenetic measuresThis 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. | Genetic | – |
Primary outcome
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.
7 secondary outcomes
Fear of recurrence
Time frame: Baseline. Through study completion, an average of 1 year.
Fatigue
Time frame: Baseline. Through study completion, an average of 1 year.
Anxiety and Depression
Time frame: Baseline. Through study completion, an average of 1 year.
Attachment
Time frame: Baseline. Through study completion, an average of 1 year.
Adverse Childhood Experiences
Time frame: Baseline. Through study completion, an average of 1 year.
Resilience
Time frame: Baseline. Through study completion, an average of 1 year.
RMSSD values
Time frame: Baseline. Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Trousselard, Pr principal investigator
UR 4360 APEMAC, University of Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Childhood Experiences and Cancer, Breast, run by University of Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of women in remission from breast cancer (time frame: Baseline. Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.