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NCT Number: NCT06330142

Hippotherapy Teenager-pediatric Radiotherapy

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.

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Key information

Conditions

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Paul Strauss

Strasbourg, 67033, France

Location status: Recruiting

Location contact

Claire DOSSUN

SUB_INVESTIGATOR

Georges NOEL

SUB_INVESTIGATOR

Laura BOINOT-FRITSCH

PRINCIPAL_INVESTIGATOR

Manon VOEGELIN

CONTACT

[email protected]

0368767360

Valérie SARTORI

CONTACT

[email protected]

0368767223

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Participation in 10 horse-assisted therapy sessions

Other

supporting children and teenagers undergoing radiotherapy with a horse-assisted therapy approach

Primary outcomes

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

    Time frame: 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 outcomes

  1. Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT

    Time frame: 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.

  2. Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT

    Time frame: 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)

  3. Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT

    Time frame: 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)

  4. Assessing the acute side effects of radiotherapy at the start and end of irradiation

    Time frame: at the start and end of radiotherapy sessions (from 3 to 7 weeks)

    Evaluation of acute toxicities induced by radiotherapy CTCAE version 5 scale

  5. Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse

    Time frame: 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.

  6. Evaluate participant's expectations and satisfaction with their care

    Time frame: at the beginning and end of HAT sessions (up to 10 weeks)

    questionnaire

  7. Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation

    Time frame: 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.

  8. Assessing the impact of HAT on the child during irradiation according to the MERT

    Time frame: at each radiotherapy session (from 3 to 7 weeks)

  9. Evaluate the rider's impression of the child's well-being of the child during HAT sessions

    Time frame: 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

  10. Assessing the impact of an alternative activity on parents' satisfaction with care

    Time frame: at the end of the HAT sessions (at 10 weeks)

    Open questionnaire at the end of HAT to be completed by parents

Study contacts

Contact information is provided by the study sponsor or research team.

Manon VOEGELIN

CONTACT

[email protected]

368767360 ext. 33

Valérie SARTORI

CONTACT

[email protected]

368767223 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Registry information

Official study title

T-QAP: radioTherapy eQuicie Adolescent - Pediatrics

Acronym: T-QAP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2024
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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