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

January 30, 2019 updated by: Centre Hospitalier Régional Metz-Thionville

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Metz, France, 57085
        • CHR Metz-Thionville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients involvement
Time Frame: week 12
acceptability of the new psychotherapy
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adequacy of the intervention with the field
Time Frame: Week 12
adaptability of the EMDR protocol
Week 12
EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires
Time Frame: Week 12
ratio of patients which wants to participate and effectively participate
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Collaborators

University of Lorraine

Investigators

  • Principal Investigator: Rafaele Longo, Dr, CHR Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

July 25, 2018

Study Completion (Actual)

July 25, 2018

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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