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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03898453
Recruitment Status : Active, not recruiting
First Posted : April 2, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
University of Lorraine
Central Hospital, Nancy, France
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Brief Summary:
The study will consist in an evaluation of the EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score (CES-D) and PTSD score, and a higher increase in quality of life.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Behavioral: EMDR psychotherapy Behavioral: support psychotherapy Not Applicable

Detailed Description:
The study will consist in an evaluation of the EMDR psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score and PTSD score, and a higher increase in quality of life (QLQ)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups assignment - One group will receive EMDR psychotherapy the other one support psychotherapy.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group EMDR psychotherapy
Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient stabilisation 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 and questionnaires Follow-up 8 (three month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)
Behavioral: EMDR psychotherapy
Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient stabilisation 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 and questionnaires Follow-up 8 (three month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)

Group Control : support psychotherapy

Visit 0 : patient inclusion (questionnaires and interview) Visits 1-7: several methods could be used: psychoeducation about cancer and psychotherapy, positive interaction and activity schedule, emotional support , relaxation, prevention techniques… Questionnaires will be completed by patients at visit 5 and 7.

Follow-up 8 (one month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)

Behavioral: support psychotherapy

Visit 0 : patient inclusion (questionnaires and interview) Visits 1-7: several methods could be used: psychoeducation about cancer and psychotherapy, positive interaction and activity schedule, emotional support , relaxation, prevention techniques… Questionnaires will be completed by patients at visit 5 and 7.

Follow-up 8 (one month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)





Primary Outcome Measures :
  1. State Anxiety [ Time Frame: Month 9 ]
    STAI-Y-A (State-Trait Anxiety Inventory) This questionnaire consists of a 20-items. The state version (STAI Y-A) indicate for 20 items and on 4-point Likert-Scale (not at all, somewhat, moderately so, and very much so) the extent to which they are currently experiencing each symptoms of anxiety. The total score ranges from 20 to 80. A higher total score indicate a higher level of anxiety.


Secondary Outcome Measures :
  1. quality of life of cancer patients [ Time Frame: Month 9 ]
    EORTC QLQ-C30 Questionnaire The European Organization for research and Treatment of Cancer 30-item Quality of life (QoL) questionnaire is a well-validated health-related QoL instrument.

  2. depression [ Time Frame: Month 9 ]
    CES-D (The Center for Epidemiologic Studies Depression) Questionnaire

  3. posttraumatic symptoms [ Time Frame: Month 9 ]
    PTGI (The Posttraumatic Growth Inventory) Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being a 18 or more year old woman
  • Having primary breast cancer and have not been re-offended and have had breast surgery for primary invasive breast cancer
  • Presenting a state-anxiety level a score higher than 35.
  • Being able to complete questionnaires.
  • Having signed the consent letter
  • Be affiliated to a social security system

Exclusion Criteria:

  • Have contraindications for EMDR psychotherapy (neurological disorders, dissociative states, oculomotor problems)
  • To have started the adjuvant treatments following the surgery since more than one month
  • Have metastatic breast cancer
  • physical multiple pathologies
  • Have a psychiatric history (including anxio-depressive disorders). Background Assessment from M.I.N.I. (Sheehan et al., 1997)
  • Present an addiction, an abuse of drugs or alcohol
  • Person placed under the protection of justice, guardianship or trusteeship.
  • Pregnant or lactating woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898453


Locations
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France
CHR Metz-Thionville
Metz, France, 57085
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
University of Lorraine
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Raffaele LONGO, Dr CHR Metz-Thionville

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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT03898453     History of Changes
Other Study ID Numbers: 2018-A01128-47
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Régional Metz-Thionville:
Breast Cancer
support psychotherapy
EMDR therapy
anxiety disorders

Additional relevant MeSH terms:
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Breast Neoplasms
Depression
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms