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| Name | Class |
|---|---|
| University of Lorraine | OTHER |
| Central Hospital, Nancy, France | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMDR psychotherapy | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 9 |
| depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raffaele LONGO, Dr | CHR Metz-Thionville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Metz-Thionville | Metz | 57085 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Two groups assignment - One group will receive EMDR psychotherapy the other one support psychotherapy.
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| support psychotherapy | Behavioral | 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) |
|
CES-D (The Center for Epidemiologic Studies Depression) Questionnaire
| Month 9 |
| posttraumatic symptoms | PTGI (The Posttraumatic Growth Inventory) Questionnaire | Month 9 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001523 | Mental Disorders |