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

NCT03271476 | Completed

• 1 other identifier: 2017-01-CHRMT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Eye Movement Desensitization and Processing; Psychoterapy

Keywords

Breast Cancer; EMDR

Outcome Measures

Primary Outcomes (1)

• patients involvement

  acceptability of the new psychotherapy

  week 12

Secondary Outcomes (2)

• adequacy of the intervention with the field

  Week 12

• EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires

  Week 12

Study Arms (1)

Arms

EXPERIMENTAL

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

Interventions

EMDR psychotherapy BEHAVIORAL

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)

Arms

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead
• University of Lorraine: collaborator

Study Sites (1)

CHR Metz-Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rafaele Longo, Dr

  CHR Metz-Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All the women will receive the same intervention.

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: September 1, 2017
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

FR (1)