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

NCT03324958 | Terminated

• 2 other identifiers: 2017-05012017-A01919-44
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

Endometrial Cancer

Keywords

Endometrial cancer; Brachytherapy; Virtual reality; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Mean pain during brachytherapy applicator installations

  Pain assessment will be done with visual analogue scale pain (line of 10 centimeters without graduation : beginning of the line means no pain, and the terminal extremity means worst pain ever felt), before and after brachytherapy applicator setting up

  1 week

Secondary Outcomes (22)

• Pain during brachytherapy applicator installations, independently at each fraction

  1 week

• Mean anxiety during brachytherapy applicator installations

  1 week

• Quality of life, six to height weeks after brachytherapy

  6 to 8 weeks after brachytherapy

• Anxiety and depression, six to height weeks after brachytherapy

  6 to 8 weeks after brachytherapy

• Correlation between mean pain during brachytherapy applicator setting up and age

  1 week

Study Arms (2)

Virtual Reality Helmet

EXPERIMENTAL

Patients will use a virtual reality helmet during brachytherapy applicator's setting up. The use of virtual reality helmet has already been assessed during oncologic treatments, and seems to reduce pain and anxiety. The use of virtual reality helmet has never been assessed to reduce the pain or anxiety associated with brachytherapy applicators' setting up.

Device: Virtual reality Helmet

No Virtual Reality Helmet

ACTIVE COMPARATOR

Patient wont use virtual reality helmet during brachytherapy applicator setting up, as in current practice.

Other: No Virtual Reality Helmet

Interventions

Virtual reality Helmet DEVICE

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.

Virtual Reality Helmet

No Virtual Reality Helmet OTHER

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

No Virtual Reality Helmet

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years old.
• Patients with endometrial cancer, with histological type I and II, regardless of the degree of differentiation.
• Patients with stage I, II or III endometrial cancer according to the FIGO classification.
• Patients treated with high-dose-rate vaginal cuff brachytherapy, with curative intent.
• Patients affiliated or entitled to a social security scheme.
• Patients who received information about the study and co-signed with the investigator the consent to participate at the study.

You may not qualify if:

• Patients with stage IV endometrial cancer according to FIGO classification.
• Patients presenting recurrence of endometrial cancer.
• Pregnant or nursing women.
• Patients under protection of justice or unable to give consent.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator
• Centre Antoine Lacassagne: collaborator
• Institut de Cancérologie de la Loire: collaborator

Study Sites (2)

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Nicolas Magné, PhD

  Institut de Cancérologie Lucien Neuwirth

  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

Model Details: Assessment of the mean local pain during brachytherapy applicator'setting up, with and without virtual reality helmet use.

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 30, 2017
• Study Start: March 26, 2019
• Primary Completion: December 1, 2020
• Study Completion: March 4, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)