VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Mean pain during brachytherapy applicator installations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean pain during brachytherapy applicator installations
时间窗: 1 week
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
次要结局
- 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)
- Correlation between mean pain during brachytherapy applicator setting up and G8 scale.(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and histologic type of cancer.(1 week)
- Pain during brachytherapy applicator installations, independently at each fraction(1 week)
- Quality of life, six to height weeks after brachytherapy(6 to 8 weeks after brachytherapy)
- Correlation between mean pain during brachytherapy applicator setting up and FIGO stage.(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and Performance status.(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and the nature of concomitant treatment.(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and the supportive cares performed(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and the radiotherapy scheme(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and the brachytherapy scheme(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)(1 week)
- Mean anxiety during brachytherapy applicator installations(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and history of pelvic surgery(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and marital status.(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and socio educational status(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and patient weight.(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and number of pregnancies.(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and the number of concomitant treatment.(1 week)
- Correlation between mean pain during brachytherapy applicator setting up and the nature of cancer treatments(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).(1 week)