EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Beast Cancer : a Faisability Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- patients involvement
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arms
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)
Intervention: EMDR psychotherapy (Behavioral)
Outcomes
Primary Outcomes
patients involvement
Time Frame: week 12
acceptability of the new psychotherapy
Secondary Outcomes
- EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires(Week 12)
- adequacy of the intervention with the field(Week 12)