Hippotherapy Teenager-pediatric Radiotherapy

Not Applicable

Recruiting

• Conditions: Radiotherapy
• Interventions: Other: Participation in 10 horse-assisted therapy sessions

• Registration Number: NCT06330142
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-26
• Study Start: 2024-06-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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
• WHO ≤ 2
• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
entire study population	Participation in 10 horse-assisted therapy sessions	-

Primary Outcome Measures

Name	Time	Method
Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy	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.

Secondary Outcome Measures

Name	Time	Method
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)	Evaluation of acute toxicities induced by radiotherapy CTCAE version 5 scale
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)	Open questionnaire at the end of HAT to be completed by parents
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	Parents (or carers) will complete a questionnaire to assess their child's quality of life.
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	The questionnaire used to assess anxiety will be completed by the child (SCARED child version)
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	Parents (or carers) will also complete a questionnaire to assess their child's anxiety (SCARED parents' version)
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)	Study the link between the various equestrian activities and the quality of life reported by children. Dashboard to track the duration of each activity carried out per child and per session, completed by the equestrian.
Evaluate participant's expectations and satisfaction with their care	at the beginning and end of HAT sessions (up to 10 weeks)	questionnaire
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)	Equestrian appreciation of the impact of HAT on the child's well-being during HAT sessions using questionnaires
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)	MERT's assessment of the impact of HAT on the child's well-being, based on a retrospective questionnaire for the previous week.

Trial Locations

Locations (1)

Institut de Cancerologie Strasbourg Europe; 🇫🇷 Strasbourg, France