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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 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-12-15

No results posted yet for this study

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

Interventions

DEVICE

Oncomfort® clinical virtual reality

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.

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Nathalie GARNIER-VIOUGEAT, MD · Fondation Hôpital Saint-Joseph

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2022-03-23
Completion
2024-01-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04574609 on ClinicalTrials.gov