Hippotherapy Teenager-pediatric Radiotherapy

Radiotherapy Clinical Trial

— T-QAP  

Official title:

T-QAP: radioTherapy eQuicie Adolescent - Pediatrics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06330142
• Other study ID #: 2022-006
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: March 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Valérie SARTORI
• Phone: 368767223
• Email: v.sartori[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Radiotherapy

Intervention

Other:
• Participation in 10 horse-assisted therapy sessions
supporting children and teenagers undergoing radiotherapy with a horse-assisted therapy approach

Locations

Country	Name	City	State
France	Institut de Cancerologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy	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.	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
Secondary	Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT	Parents (or carers) will complete a questionnaire to assess their child's quality of life.	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
Secondary	Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT	The questionnaire used to assess anxiety will be completed by the child (SCARED child version)	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
Secondary	Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT	Parents (or carers) will also complete a questionnaire to assess their child's anxiety (SCARED parents' version)	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
Secondary	Assessing the acute side effects of radiotherapy at the start and end of irradiation	Evaluation of acute toxicities induced by radiotherapy CTCAE version 5 scale	at the start and end of radiotherapy sessions (from 3 to 7 weeks)
Secondary	Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse	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.	At every HAT sessions (up to 10 weeks)
Secondary	Evaluate participant's expectations and satisfaction with their care	questionnaire	at the beginning and end of HAT sessions (up to 10 weeks)
Secondary	Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation	MERT's assessment of the impact of HAT on the child's well-being, based on a retrospective questionnaire for the previous week.	every week during radiotherapy (from 3 to 7 weeks)
Secondary	Assessing the impact of HAT on the child during irradiation according to the MERT		at each radiotherapy session (from 3 to 7 weeks)
Secondary	Evaluate the rider's impression of the child's well-being of the child during HAT sessions	Equestrian appreciation of the impact of HAT on the child's well-being during HAT sessions using questionnaires	at the end of the first session and at the end of the last session of HAT (up to 10 weeks)
Secondary	Assessing the impact of an alternative activity on parents' satisfaction with care	Open questionnaire at the end of HAT to be completed by parents	at the end of the HAT sessions (at 10 weeks)