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

Primary Purpose

Breast Cancer Female

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EMDR psychotherapy
support 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 Female focused on measuring Breast Cancer, support psychotherapy, EMDR therapy, anxiety disorders

Eligibility Criteria

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

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

Sites / Locations

  • CHR Metz-Thionville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group EMDR psychotherapy

Group Control : support psychotherapy

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
depression
CES-D (The Center for Epidemiologic Studies Depression) Questionnaire
posttraumatic symptoms
PTGI (The Posttraumatic Growth Inventory) Questionnaire

Full Information

First Posted
January 30, 2019
Last Updated
October 19, 2023
Sponsor
Centre Hospitalier Régional Metz-Thionville
Collaborators
University of Lorraine, Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03898453
Brief Title
EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient
Acronym
PSYCANCER
Official Title
EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
September 24, 2023 (Actual)
Study Completion Date
September 24, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Breast Cancer, support psychotherapy, EMDR therapy, anxiety disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups assignment - One group will receive EMDR psychotherapy the other one support psychotherapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group EMDR psychotherapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Group Control : support psychotherapy
Arm Type
Other
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
EMDR psychotherapy
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
support psychotherapy
Intervention Description
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 Measure Information:
Title
State Anxiety
Description
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.
Time Frame
Month 9
Secondary Outcome Measure Information:
Title
quality of life of cancer patients
Description
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.
Time Frame
Month 9
Title
depression
Description
CES-D (The Center for Epidemiologic Studies Depression) Questionnaire
Time Frame
Month 9
Title
posttraumatic symptoms
Description
PTGI (The Posttraumatic Growth Inventory) Questionnaire
Time Frame
Month 9

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaele 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
No

Learn more about this trial

EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient

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