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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: hypnosis

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • Institut régional du Cancer de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis; The patient achieve self-hypnosis sessions in these chemotherapy treatments	Behavioral: hypnosis; The patient achieve self-hypnosis sessions in these chemotherapy treatments

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

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Study Chair: Michel FABBRO, Institut régional du Cancer de Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): June 6, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ICM-URC-2014/ 31

Plan for Individual participant data (IPD)

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