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.
Endometrial cancer is one of the most common gynaecological cancers among women in the developed countries. After a curative surgical treatment, many relapses occur in the vaginal cuff. The PORTEC-2 trial has demonstrated a similar reduction in local relapses of intermediate- to high-risk endometrial cancer with vaginal cuff brachytherapy (VCB) than with external beam radiotherapy (EBRT). However, VCB induced less late toxicities. VCB is therefore indicated after surgery for intermediate- to high-risk endometrial cancer. VCB is also recommended after radiation therapy, for patients with stage II or III type 1 endometrial cancers according to the International Federation of Gynaecology and Obstetrics classification (FIGO), and for all patients with histological type 2 endometrial cancers. If the late tolerance of VCB is correct, the acute tolerance remains limited, and is mainly characterized by local pain and anxiety) Virtual reality appears to be a promising tool to enhance treatment cancer tolerance, offering a safe and entertaining environment. By the way, the use of virtual reality could limit physical and psychical discomfort induced by VCB. This randomized phase III multicenter trial aims to assess the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain (primary endpoint), and in terms of anxiety (secondary endpoint). Randomization will define which patient will wear a virtual reality helmet. Stratification will be performed according to the following criteria: vaginal molded applicator versus cylinder, two applications versus four; \<70 years versus\> 70 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
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.
The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
Institut Gustave Roussy
Villejuif, France
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
Time frame: 1 week
Pain during brachytherapy applicator installations, independently at each fraction
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.
Time frame: 1 week
Mean anxiety during brachytherapy applicator installations
Anxiety assessment will be done with visual analogue scale (line of 10 centimeters without graduation : beginning of the line means no pain, and the terminal extremity means worst pain ever felt) anxiety, before and after brachytherapy applicator setting up, and with Hamilton scale (scores will be comprised between 0 : no anxiety, and 30 : maximal anxiety) before brachytherapy applicator setting up.
Time frame: 1 week
Quality of life, six to height weeks after brachytherapy
Quality of life assessment will be done with the the endometrial cancer (EC)-specific Quality of Life module of the European Organization for Research and Treatment of Cancer (EORTC QLQ-EN24).
Time frame: 6 to 8 weeks after brachytherapy
Anxiety and depression, six to height weeks after brachytherapy
Anxiety and depression will be assessed six to height weeks after brachytherapy with the Hamilton Anxiety and Depression scale (scores will be comprised between 0 : no anxiety, and 30 : maximal anxiety).
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Time frame: 6 to 8 weeks after brachytherapy
Correlation between mean pain during brachytherapy applicator setting up and age
Correlation will potentially be established between pain during brachytherapy applicator setting up and age.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and G8 scale.
Correlation will potentially be established between pain during brachytherapy applicator setting up and G8 scale.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and histologic type of cancer.
Correlation will potentially be established between pain during brachytherapy applicator setting up and histologic type of cancer.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and FIGO stage.
Correlation will potentially be established between pain during brachytherapy applicator setting up and FIGO stage.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and Performance status.
Correlation will potentially be established between pain during brachytherapy applicator setting up and Performance status.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and patient weight.
Correlation will potentially be established between pain during brachytherapy applicator setting up and patient weight.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and marital status.
Correlation will potentially be established between pain during brachytherapy applicator setting up and marital status.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and socio educational status
Correlation will potentially be established between pain during brachytherapy applicator setting up and socio educational status.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and number of pregnancies.
Correlation will potentially be established between pain during brachytherapy applicator setting up and number of pregnancies.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and history of pelvic surgery
Correlation will potentially be established between pain during brachytherapy applicator setting up and history of pelvic surgery.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the number of concomitant treatment.
Correlation will potentially be established between pain during brachytherapy applicator setting up and the number of concomitant treatment.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of concomitant treatment.
Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of concomitant treatment.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the nature of cancer treatments
Correlation will potentially be established between pain during brachytherapy applicator setting up and the nature of cancer treatments.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the supportive cares performed
Correlation will potentially be established between pain during brachytherapy applicator setting up and the supportive cares performed.
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy scheme
Correlation will potentially be established between pain during brachytherapy applicator setting up and the radiotherapy achievement
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the brachytherapy scheme
Correlation will potentially be established between pain during brachytherapy applicator setting up and the brachytherapy scheme
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4)
Correlation will potentially be established between pain during brachytherapy applicator setting up and the radiotherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4).
Time frame: 1 week
Correlation between mean pain during brachytherapy applicator setting up and the toxicities of previous brachytherapy fractions (describe according to the Common Terminology Criteria for Adverse Events 4.4).
Correlation will potentially be established between pain during brachytherapy applicator setting up and the brachytherapy induced toxicities (describe according to the Common Terminology Criteria for Adverse Events 4.4).
Time frame: 1 week