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

EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: EMDR psychotherapy; Behavioral: support psychotherapy

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)

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cyril Tarquinio, Pr; Phone Number: +33 6 01 17 67 82; Email: cyril.tarquinio@univ-lorraine.fr
• Study Contact Backup: Name: Christine Rotonda, PhD; Phone Number: +33 3 72 74 82 26; Email: christine.rotonda@univ-lorraine.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being a 18 or more year old woman
• Having primary breast cancer or going to start treatment or having completed treatments for less than 6 months
• 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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Anxiety	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.	Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life of cancer patients	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.	Month 9
depression	CES-D (The Center for Epidemiologic Studies Depression) Questionnaire	Month 9
posttraumatic symptoms	PTGI (The Posttraumatic Growth Inventory) Questionnaire	Month 9

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Collaborators: Central Hospital, Nancy, France; University of Lorraine
• Investigators: Principal Investigator: Raffaele LONGO, Dr, CHR Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): September 24, 2023
• Study Completion (Actual): September 24, 2023

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; anxiety disorders; support psychotherapy; EMDR therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Depression; Breast Neoplasms
• Other Study ID Numbers: 2018-A01128-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No