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

Primary Purpose

Breast Cancer, Eye Movement Desensitization and Processing, Psychoterapy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EMDR psychotherapy
Sponsored by
Centre Hospitalier Régional Metz-Thionville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, EMDR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHR Metz-Thionville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arms

Arm Description

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)

Outcomes

Primary Outcome Measures

patients involvement
acceptability of the new psychotherapy

Secondary Outcome Measures

adequacy of the intervention with the field
adaptability of the EMDR protocol
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

Full Information

First Posted
August 29, 2017
Last Updated
January 30, 2019
Sponsor
Centre Hospitalier Régional Metz-Thionville
Collaborators
University of Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT03271476
Brief Title
EMDR Psychotherapy to Treat Anxious-depressive Symptoms in Breast Cancer Patient
Acronym
PSYCANCER
Official Title
EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Beast Cancer : a Faisability Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
July 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
Collaborators
University of Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Eye Movement Desensitization and Processing, Psychoterapy
Keywords
Breast Cancer, EMDR

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All the women will receive the same intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arms
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
EMDR psychotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
patients involvement
Description
acceptability of the new psychotherapy
Time Frame
week 12
Secondary Outcome Measure Information:
Title
adequacy of the intervention with the field
Description
adaptability of the EMDR protocol
Time Frame
Week 12
Title
EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires
Description
ratio of patients which wants to participate and effectively participate
Time Frame
Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafaele Longo, Dr
Organizational Affiliation
CHR Metz-Thionville
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Metz-Thionville
City
Metz
ZIP/Postal Code
57085
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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