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Clinical Trial NCT06330142 (T-QAP) for Radiotherapy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Hippotherapy Teenager-pediatric Radiotherapy (T-QAP) 22 Pediatric Adolescent

Recruiting
Clinical Trial NCT06330142 (T-QAP) is an interventional study for Radiotherapy that is recruiting. It started on 19 June 2024 with plans to enroll 22 participants. Led by Centre Paul Strauss, it is expected to complete by 19 June 2027. The latest data from ClinicalTrials.gov was last updated on 23 December 2025.
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 sta...

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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 trea...Show More
Official Title

T-QAP: radioTherapy eQuicie Adolescent - Pediatrics

Conditions
Radiotherapy
Other Study IDs
  • T-QAP
  • 2022-006
NCT ID Number
NCT06330142
Start Date (Actual)
2024-06-19
Last Update Posted
2025-12-23
Completion Date (Estimated)
2027-06-19
Enrollment (Estimated)
22
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Radiotherapy
Equicie
Adolescent
Pediatric
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Otherentire study population
Participation in 10 horse-assisted therapy sessions
supporting children and teenagers undergoing radiotherapy with a horse-assisted therapy approach
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
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
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
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)
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)
Evaluate participant's expectations and satisfaction with their care
questionnaire
at the beginning and end of HAT sessions (up to 10 weeks)
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)
Assessing the impact of HAT on the child during irradiation according to the MERT
at each radiotherapy session (from 3 to 7 weeks)
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)
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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
8 Years
Eligible Sexes
All
  • 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

  • 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
Centre Paul Strauss logoCentre Paul Strauss
Study Central Contact
Contact: Valérie SARTORI, 368767223, [email protected]
Contact: Manon VOEGELIN, 368767360, [email protected]
1 Study Locations in 1 Countries
Centre Paul Strauss, Strasbourg, 67033, France
Valérie SARTORI, Contact, 0368767223, [email protected]
Manon VOEGELIN, Contact, 0368767360, [email protected]
Laura BOINOT-FRITSCH, Principal Investigator
Georges NOEL, Sub-Investigator
Claire DOSSUN, Sub-Investigator
Recruiting