EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient (PSYCANCER)

Centre Hospitalier Régional Metz-Thionville

Status: Completed

Conditions: Breast Cancer Female

Treatments: Behavioral: EMDR psychotherapy; Behavioral: support psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03898453

2018-A01128-47

Details and patient eligibility

About

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.

Full 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)

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Group EMDR psychotherapy

Experimental group

Description:

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)

Treatment:

Behavioral: EMDR psychotherapy

Group Control : support psychotherapy

Other group

Description:

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)

Treatment:

Behavioral: support psychotherapy