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

Breast Cancer Clinical Trial

— PSYCANCER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271476
• Other study ID #: 2017-01-CHRMT
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 25, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 25, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Depression
• Eye Movement Desensitization and Processing
• Psychoterapy

Intervention

Behavioral:
• EMDR psychotherapy
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)

Locations

Country	Name	City	State
France	CHR Metz-Thionville	Metz

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville	University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients involvement	acceptability of the new psychotherapy	week 12
Secondary	adequacy of the intervention with the field	adaptability of the EMDR protocol	Week 12
Secondary	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