Hypnosis for Patients Treated With Adjuvant Chemotherapy for Breast Cancer(HYPNOVAL)

Study Overview
=================
Brief Summary
-----------------
The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

Detailed Description
-----------------
In the field of management of cancer, many approaches have been used since tens of years, particularly in regard of pain management, both in achieving surgical or invasive procedures in the pain induced by the disease itself. the investigators owe the first description in 1829 Chapelin and col who used hypnosis in a patient with breast cancer in which a mastectomy should be performed. Meta-analysis (2000) showed the positive impact of analgesia obtained through hypnosis on the perception of pain intensity. In children in whom regular venous punctures is performed, using hypnosis seems indisputable on the management of anticipatory anxiety, leading to a better experience of the act itself. Regarding the nausea and vomiting induced by chemotherapy, numerous studies are old, not always randomized and performed often before the era of the setrons; but seems favorable impact on anticipated nausea and vomiting, the updated studies should emerge on the issue of delayed emesis which remain a serious adverse event and not completely resolved. Mark to improve the EORTC validated tools of quality of life measurement widely used for example in ovarian cancer. The impact of hypnosis on the quality of life or the side effects of treatment or rehospitalization for toxicity remains controversial (Judson, 2011). A meta-analysis combining the tests carried out before and after the era of setrons (Richardson, 2007) concluded that the effectiveness of the anticipated nausea and vomiting. In this context,the investigators proposed to conduct a feasibility study to evaluate the role and impact of medical Ericksonian hypnosis on acute and delayed adverse event (incl nausea and vomiting) in female patients treated by adjuvant chemotherapy for breast cancer. The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy

Official Title
-----------------
Medical Ericksonian Hypnosis on Patients Treated With Adjuvant Chemotherapy for Breast Cancer at the ICM Val d'Aurelle - Montpellier: a Feasibility Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: hypnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Female, age > 18 years-old Without previous practice of hypnosis Patient with diagnosis of breast cancer Patient receiving an adjuvant chemotherapy for at least 3 months with an indication of radiotherapy after chemotherapy Patient accepting the principle of the study with a signed written informed consent Patient affiliated to French Social Security Exclusion Criteria: • Male Age < 18 years Patient refusing hypnosis Pregnancy, breast-feeding, or lack of effective contraception in female patients with reproductive potential. Patient with psychological or mental disorders under psychotropic treatments (lithium, neuroleptics) Not ability to speak and read French, deaf and/or mute

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis<br>The patient achieve self-hypnosis sessions in these chemotherapy treatments | Behavioral: hypnosis<br>* The patient achieve self-hypnosis sessions in these chemotherapy treatments<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients rated as being compliant to self-hypnosis | The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy. Primary endpoint is the proportion of patients rated as being compliant to self-hypnosis sessions during adjuvant chemotherapy (6 sessions). A patient is considered as compliant if it achieves at least 2/3 of the planned self-hypnosis sessions, that is, 4 of 6 planned sessions. | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of hypnosis on the tolerance of the CT | The secondary objective is to describe its impact on the tolerance of the CT | through study completion, an average of 2 years |