Breast Cancer FemalePSYCANCERNCT03898453
EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient
A study testing EMDR psychotherapy and support psychotherapy in people with Breast Cancer Female, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
The study will consist in an evaluation of the EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- EMDR psychotherapy and support psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2019to 24 Sep 2023
- Phase
- Interventional
- 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
Who may be able to join
- Being a 18 or more year old woman
- Having primary breast cancer or going to start treatment or having completed treatments for less than 6 months
- Presenting a state-anxiety level a score higher than 35.
- Being able to complete questionnaires.
- Having signed the consent letter
- Be affiliated to a social security system
Who cannot join
- Have contraindications for EMDR psychotherapy (neurological disorders, dissociative states, oculomotor problems)
- Have metastatic breast cancer
- physical multiple pathologies
- Have a psychiatric history (including anxio-depressive disorders). Background Assessment from M.I.N.I. (Sheehan et al., 1997)
- Present an addiction, an abuse of drugs or alcohol
- Person placed under the protection of justice, guardianship or trusteeship.
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial
The study will consist in an evaluation of the EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score (CES-D) and PTSD score, and a higher increase in quality of life.
Read the detailed description
The study will consist in an evaluation of the EMDR psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score and PTSD score, and a higher increase in quality of life (QLQ)
- Conditions
- Breast Cancer Female
- Being tested
- EMDR psychotherapy, support psychotherapy
- Keywords
- Breast Cancer, support psychotherapy, EMDR therapy, anxiety disorders
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR psychotherapyBehavioural
Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient stabilisation Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care and questionnaires Follow-up 8 (three month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)
support psychotherapyBehavioural
Visit 0 : patient inclusion (questionnaires and interview) Visits 1-7: several methods could be used: psychoeducation about cancer and psychotherapy, positive interaction and activity schedule, emotional support , relaxation, prevention techniques… Questionnaires will be completed by patients at visit 5 and 7.
Follow-up 8 (one month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)
| Study group | Role | What they receive |
|---|---|---|
| Group EMDR psychotherapy | Experimental | Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient stabilisation Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care and questionnaires Follow-up 8 (three month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires) Receives: Behavioral: EMDR psychotherapy |
| Group Control : support psychotherapy | Other | Visit 0 : patient inclusion (questionnaires and interview) Visits 1-7: several methods could be used: psychoeducation about cancer and psychotherapy, positive interaction and activity schedule, emotional support , relaxation, prevention techniques… Questionnaires will be completed by patients at visit 5 and 7.
Follow-up 8 (one month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires) Receives: Behavioral: support psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety
STAI-Y-A (State-Trait Anxiety Inventory) This questionnaire consists of a 20-items. The state version (STAI Y-A) indicate for 20 items and on 4-point Likert-Scale (not at all, somewhat, moderately so, and very much so) the extent to which they are currently experiencing each symptoms of anxiety. The total score ranges from 20 to 80. A higher total score indicate a higher level of anxiety.
Measured: Month 9
Secondary outcomes (3)
quality of life of cancer patients
EORTC QLQ-C30 Questionnaire The European Organization for research and Treatment of Cancer 30-item Quality of life (QoL) questionnaire is a well-validated health-related QoL instrument.
Measured: Month 9
depression
CES-D (The Center for Epidemiologic Studies Depression) Questionnaire
Measured: Month 9
posttraumatic symptoms
PTGI (The Posttraumatic Growth Inventory) Questionnaire
Measured: Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start11 Mar 2019
- Primary completion24 Sep 2023
- Study completion24 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups assignment - One group will receive EMDR psychotherapy the other one support psychotherapy.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine, Central Hospital, Nancy, France
- Responsible party
- Sponsor
- Investigators
- Raffaele LONGO, Dr, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898453
- Sponsor's protocol ID
- 2018-A01128-47
- Acronym
- PSYCANCER
- Status last verified
- Sep 2022
- First submitted
- 30 Jan 2019
- Last updated
- 23 Oct 2023
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03898453
- Acronym / sponsor ID
- PSYCANCER / 2018-A01128-47
- Conditions
- Breast Cancer Female
- Keywords
- Breast Cancer, support psychotherapy, EMDR therapy, anxiety disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Collaborators
- University of Lorraine, Central Hospital, Nancy, France
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 2 Apr 2019 (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.
The study will consist in an evaluation of the EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score (CES-D) and PTSD score, and a higher increase in quality of life.
Detailed description
The study will consist in an evaluation of the EMDR psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score and PTSD score, and a higher increase in quality of life (QLQ)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups assignment - One group will receive EMDR psychotherapy the other one support psychotherapy.
| Arm | Type | Receives |
|---|---|---|
| Group EMDR psychotherapy | Experimental | Behavioral: EMDR psychotherapyVisit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient stabilisation Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care and questionnaires Follow-up 8 (three month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires) |
| Group Control : support psychotherapy | Other | Behavioral: support psychotherapyVisit 0 : patient inclusion (questionnaires and interview) Visits 1-7: several methods could be used: psychoeducation about cancer and psychotherapy, positive interaction and activity schedule, emotional support , relaxation, prevention techniques… Questionnaires will be completed by patients at visit 5 and 7. Follow-up 8 (one month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being a 18 or more year old woman
- Having primary breast cancer or going to start treatment or having completed treatments for less than 6 months
- Presenting a state-anxiety level a score higher than 35.
- Being able to complete questionnaires.
- Having signed the consent letter
Key exclusion criteria (7 listed)
- Have contraindications for EMDR psychotherapy (neurological disorders, dissociative states, oculomotor problems)
- Have metastatic breast cancer
- physical multiple pathologies
- Have a psychiatric history (including anxio-depressive disorders). Background Assessment from M.I.N.I. (Sheehan et al., 1997)
- Present an addiction, an abuse of drugs or alcohol
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 |
|---|---|---|
| EMDR psychotherapyVisit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient stabilisation Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care and questionnaires Follow-up 8 (three month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires) | Behavioural | Group EMDR psychotherapy |
| support psychotherapyVisit 0 : patient inclusion (questionnaires and interview) Visits 1-7: several methods could be used: psychoeducation about cancer and psychotherapy, positive interaction and activity schedule, emotional support , relaxation, prevention techniques… Questionnaires will be completed by patients at visit 5 and 7. Follow-up 8 (one month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires) | Behavioural | Group Control : support psychotherapy |
Primary outcome
State Anxiety
Time frame: Month 9
STAI-Y-A (State-Trait Anxiety Inventory) This questionnaire consists of a 20-items. The state version (STAI Y-A) indicate for 20 items and on 4-point Likert-Scale (not at all, somewhat, moderately so, and very much so) the extent to which they are currently experiencing each symptoms of anxiety. The total score ranges from 20 to 80. A higher total score indicate a higher level of anxiety.
3 secondary outcomes
quality of life of cancer patients
Time frame: Month 9
depression
Time frame: Month 9
posttraumatic symptoms
Time frame: Month 9
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 23 Oct 2023.
- 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.
Raffaele LONGO, Dr principal investigator
CHR Metz-Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR psychotherapy and support psychotherapy in people with Breast Cancer Female, run by Centre Hospitalier Régional Metz-Thionville 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 6 inclusion and 7 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 23 Oct 2023. 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?
State Anxiety (time frame: Month 9). 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 23 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.