T-QAP: radioTherapy eQuicie Adolescent - Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy
研究概览
简要总结
This study proposes a horse-assisted therapy (HAT) approach to accompany children and young adults undergoing irradiation in the ICANS Radiotherapy Department.
The aim of this new approach is to improve quality of life and reduce anxiety in children and adolescents treated with radiotherapy. The impact of equine-assisted therapy on quality of life and anxiety disorders will be described prospectively between the start and end of irradiation in children and parents who agree to inclusion.
详细描述
Electro-radiology medical technician (ERMT) are privileged contacts with children. They accompany them every day during radiotherapy sessions. An animal-mediated approach would provide a new out-of-hospital environment. The equine sessions, precious moments when the child can forget about his illness, would enable him to escape from his condition as a patient. Indeed, the sick child adopts a posture to withstand treatment and take on responsibilities such as "not crying" and "being brave". These moments, away from the hospital, are essential to the smooth running of care, since they limit the weariness induced by daily radiotherapy sessions and help preserve the quality of caregiver/child cooperation during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8 to <18 years.
- •With an indication for radiotherapy for cancer (of any type)
- •Patients hospitalized and/or managed on an ambulatory basis
- •Child and parents (or accompanying adults) who speak and understand French
- •Free, express and informed consent of the adult patient OR of those exercising parental authority for minor patients
- •Child with social security coverage
排除标准
- •Children afraid of horses and stables
- •Contraindication to the practice of equine-assisted therapy (allergy to horses or dust, children with asthma attacks triggered by dust/animal hair ...)
- •Patient on stretcher
- •Children or parents (or carers) with significant cognitive impairment, making self-assessment or hetero-assessment impossible even with assistance
- •Unavailability or lack of interest in participating in equine-assisted therapy sessions
研究组 & 干预措施
entire study population
干预措施: Participation in 10 horse-assisted therapy sessions (Other)
结局指标
主要结局
Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy
时间窗: before radiotherapy, halfway through the HAT sessions (at 5 weeks), at the end of the HAT sessions (at 10 weeks) and one month after the end of the HAT sessions
The questionnaire used to assess quality of life will be completed by the child. Two versions of the VSP-A questionnaire exist, depending on the child's age (versions \< 10 years and 10-17 years). Results can be compared with reference values for the general population.
次要结局
- Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT(before radiotherapy, halfway through the HAT sessions (at 5 weeks), at the end of the HAT sessions (at 10 weeks) and one month after the end of the HAT sessions)
- Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT(before radiotherapy, halfway through HAT sessions (at 5 weeks), at the end of HAT sessions (at 10 weeks) and one month after the end of HAT sessions)
- Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT(before radiotherapy, halfway through HAT sessions (at 5 weeks), at the end of HAT sessions (at 10 weeks) and one month after the end of HAT sessions)
- Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse(At every HAT sessions (up to 10 weeks))
- Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation(every week during radiotherapy (from 3 to 7 weeks))
- Assessing the acute side effects of radiotherapy at the start and end of irradiation(at the start and end of radiotherapy sessions (from 3 to 7 weeks))
- Assessing the impact of HAT on the child during irradiation according to the MERT(at each radiotherapy session (from 3 to 7 weeks))
- Assessing the impact of an alternative activity on parents' satisfaction with care(at the end of the HAT sessions (at 10 weeks))
- Evaluate participant's expectations and satisfaction with their care(at the beginning and end of HAT sessions (up to 10 weeks))
- Evaluate the rider's impression of the child's well-being of the child during HAT sessions(at the end of the first session and at the end of the last session of HAT (up to 10 weeks))