Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Toolalong the Care Pathway of Patients Undergoing Breast Cancer Treatment.

NCT04574609 | Unknown

• 1 other identifier: HYGEE
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

In 2017, it is estimated that nearly 60,000 new cases of breast cancer will be diagnosed in France. Although several treatments are indicated in this context, chemotherapy remains a curability option whose place today extends to small tumors to support its increasingly approved administration contributing to a continuous increase in survival rates. However, diagnostic procedures and anti-cancer treatments are frequently responsible for toxicity that can reach high levels of severity and even generate sequelae. These physical and psychological after-effects of breast cancer treatment have a short and medium-term impact on the quality of life of the patients treated: anxiety, fear, pain, job loss, and the onset of precariousness. In addition, surgical procedures such as PAC and pic-line surgery are often associated with anxiety and pain. Chemotherapy is particularly associated with anxiety, stress, fatigue, nausea and vomiting. Some immediate, delayed or even anticipated side effects are not always effectively controlled by the medication available to us. Anti-nausea medications can lead to drug interactions and/or other adverse effects. The interest of a non-drug approach is to get rid of these adverse effects. However, it is underestimated and therefore currently not integrated into current practice. Its benefits must therefore be explored within the framework of in-depth research protocols that justify our study.

Conditions

Breast Cancer

Keywords

hypnotherapy; virtual reality; anxiety; pain

Outcome Measures

Primary Outcomes (1)

• Evaluate, in patients undergoing chemotherapy for the treatment of breast cancer, the impact of the use of hypnotherapy performed by a virtual reality tool on the anxiety felt just before the PAC procedure.

  Difference between the 2 groups of patients in terms of the anxiety felt just before the PAC procedure, evaluated by the Spielberger's State Anxiety Scale (STAI form Y-A). This scale evaluates the feelings of apprehension, tension, nervousness and anxiety that the subject feels at the time of the anxiety-provoking or competitive situation.

  Day 7

Secondary Outcomes (5)

• Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy performed by a virtual reality tool on the maximum pain and its duration felt by patients since the insertion of PAC.

  Day 7

• Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on the incidence of chemotherapy associated adverse events.

  Day 7

• Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on quality of life as measured by the QLC30 scale at the end of chemotherapy.

  1 year

• Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on the quality of life measured on the QBR23 scale at the end of chemotherapy.

  1 year

• Evaluate the impact of the use of hypnotherapy on the immune system in patients undergoing chemotherapy for the treatment of breast cancer using a virtual reality tool.

  Day 7 and 1 year

Study Arms (2)

no hypnotherapy

NO INTERVENTION

A "control" group of patients receiving the usual management for PAC and chemotherapy sessions.

hypnotherapy

EXPERIMENTAL

A "hypnotherapy" group of patients benefiting from hypnotherapy sessions prior to PAC and chemotherapy cures in addition to the usual management.

Device: Oncomfort® clinical virtual reality

Interventions

Oncomfort® clinical virtual reality DEVICE

hypnotherapy" arm, patients will receive in addition to the care provided by the usual : * for PAC insertion: a 45-minute hypnotherapy session 2 hours before the procedure in a room of the outpatient surgery unit (UCA). * during the entire duration of chemotherapy (and/or immunotherapy for HER2+ patients) : one hypnotherapy session before the first treatment and then every 3 weeks. One hypnotherapy session before the first treatment and then every 3 weeks. Thus, sessions will take place before each treatment for 3-week inter-course regimens and every 3 treatments for chemotherapy administered on a weekly. Each session will last 20 minutes.

hypnotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman whose age ≥ 18 years old
• Negative pregnancy test for women of childbearing age
• Francophone patient
• Patient newly diagnosed with localized or metastatic breast cancer at the Paris Saint-Joseph Hospital Group (GhPSJ).
• Patients in whom adjuvant or neoadjuvant chemotherapy treatment is planned
• Patient affiliated to the social security system or, failing that, to another health insurance system
• Patient who has given written consent.

You may not qualify if:

• Psychotic patients (paranoia, schizophrenia and manic-depressive psychosis)
• Patient suffering from pathological dissociations
• Deaf and hard of hearing
• Blind and severely visually impaired
• Patient suffering from wounds or infections in the head area
• Patient suffering from respiratory disorders
• Patient with a high level of claustrophobia
• Patient whose investigator determines that he or she cannot wear a virtual reality helmet
• Patient under guardianship or curatorship
• Patient deprived of liberty.
• Pregnant or breastfeeding patient.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie GARNIER-VIOUGEAT, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 5, 2020
• Study Start: September 24, 2020
• Primary Completion: March 23, 2022
• Study Completion: January 30, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

FR (1)