VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.

NCT03324958 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-02-08

No results posted yet for this study

Summary

This randomized phase III multicenter trial aims to evaluate the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain and anxiety.

Conditions

Interventions

DEVICE

Virtual reality Helmet

The virtual reality helmet will be installed by a radiotherapist or a radiotherapy manipulator, just before the intra vaginal applicator. The virtual reality headset will be connected to a dedicated computer. The virtual reality program will run for 10 minutes which will cover the entire procedure for setting up the brachytherapy device. In order to optimize the distractive potential of virtual reality, four different virtual reality programs will be offered to patients during each brachytherapy fraction. These programs will be contemplative so as not to compromise the immobility of the patients during the installation of the brachytherapy applicator.

OTHER

No Virtual Reality Helmet

The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER
  • Centre Antoine Lacassagne

    collaborator OTHER
  • Institut de Cancérologie de la Loire

    collaborator OTHER
  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Nicolas Magné, PhD · Institut de Cancérologie Lucien Neuwirth

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2020-12-01
Completion
2021-03-04

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT03324958 on ClinicalTrials.gov