EMDR Psychotherapy to Treat Anxious-depressive Symptoms in Breast Cancer Patient

Study Overview
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Brief Summary
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The study will consist in an adjustment/adaptation of the standard EMDR protocol for cancer disease, and most particulary for women who present a breast cancer and during adjuvant therapy. It will also test the faisability of the research, with a view to adjust the calendar and the ressources to put at disposal for a randomized control trial that follow. This study will also allow to test the need and acceptibility of this new psychotherapy for the patient, and to identify facilitators and obstacles : participation/rejection ratio, inclusion rythm, adhesion of the medical staff about the project

Official Title
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EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Beast Cancer : a Faisability Study

Conditions
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Breast Cancer, Eye Movement Desensitization and Processing, Psychoterapy

Intervention / Treatment
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* Behavioral: EMDR psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a woman aged of 18 years or more Having a primary invasive breast cancer Having undergo a mastectomy for a primary invasive breast cancer Being able to complete the questionnaires Being informed of the study and having signed the informed consent Being affiliated to a welfare system Exclusion Criteria: having contraindications to recieve EMDR psychotherapy (neurologic disorders, dissociatif states, oculomotor issues) Having started adjuvant treatments following surgery Having metastatic breast cancer Presenting physical polypathologies Having psychiatric antecedents (included anxiety and depressif disorders - assessed with M.I.N.I. (Sheehan and al., 1997)). Having drug or alcohol addiction Being placed under the safeguard of justice, guardianship or trusteeship Being pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All the women will receive the same intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arms<br>Experimental: EMDR psychotherapy All the women will be in this arm and thus will receive the same intervention which is : 8 sessions (1 per week). The first session is an inclusion visit at Metz-Thionville Hospital, then 6 EMDR psychotherapy sessions and finally a last visit one month after for data recovery (questionnaire and semi-directive interview) | Behavioral: EMDR psychotherapy<br>* Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient supporting 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 Visit 8 : EMDR psychotherapy care ans questionnaires Visit 9 (one month after) : semi-directive interview and data recovery (questionnaires)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients involvement | acceptability of the new psychotherapy | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequacy of the intervention with the field | adaptability of the EMDR protocol | Week 12 | 
| EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires | ratio of patients which wants to participate and effectively participate | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, EMDR