Breast CancerPSYCANCERNCT03271476
EMDR Psychotherapy to Treat Anxious-depressive Symptoms in Breast Cancer Patient
A study testing EMDR psychotherapy in people with Breast Cancer and Eye Movement Desensitization and Processing, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Eye Movement Desensitization and Processing, Psychoterapy
- What is being tested?
- EMDR psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 25 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- EMDR psychotherapy
- Keywords
- Breast Cancer, EMDR
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR psychotherapyBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Arms | Experimental | 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) Receives: Behavioral: EMDR psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients involvement
acceptability of the new psychotherapy
Measured: week 12
Secondary outcomes (2)
adequacy of the intervention with the field
adaptability of the EMDR protocol
Measured: Week 12
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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Sep 2017
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the women will receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Sponsor
- Investigators
- Rafaele Longo, Dr, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271476
- Sponsor's protocol ID
- 2017-01-CHRMT
- Acronym
- PSYCANCER
- Status last verified
- Jan 2019
- First submitted
- 29 Aug 2017
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tarquinio, C. , Machado, J. , Longo, R. , Siles, J. , Bruno, J. , Gendarme, S. , Ziegler, A. , Mellouki, N. , Eby, E. and Rotonda, C. (2022) The Treatment of Anxious-Depressive Disorders among Breast Cancer Patients Integrating the EMDR Psychotherapy: From Pilot Study Results to the Development of a Randomized Trial. Psychology, 13, 313-327. doi: 10.4236/psych.2022.133019.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Beast Cancer : a Faisability Study
- ClinicalTrials.gov ID
- NCT03271476
- Acronym / sponsor ID
- PSYCANCER / 2017-01-CHRMT
- Keywords
- Breast Cancer, EMDR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the women will receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Arms | Experimental | Behavioral: EMDR psychotherapyExperimental: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR psychotherapyVisit 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) | Behavioural | Arms |
Primary outcome
patients involvement
Time frame: week 12
acceptability of the new psychotherapy
2 secondary outcomes
adequacy of the intervention with the field
Time frame: Week 12
EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publicationTarquinio, C. , Machado, J. , Longo, R. , Siles, J. , Bruno, J. , Gendarme, S. , Ziegler, A. , Mellouki, N. , Eby, E. and Rotonda, C. (2022) The Treatment of Anxious-Depressive Disorders among Breast Cancer Patients Integrating the EMDR Psychotherapy: From Pilot Study Results to the Development of a Randomized Trial. Psychology, 13, 313-327. doi: 10.4236/psych.2022.133019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafaele Longo, Dr principal investigator
CHR Metz-Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR psychotherapy in people with Breast Cancer and Eye Movement Desensitization and Processing, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients involvement (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.