NCT06330142

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Jun 2024Jun 2027

First Submitted

Initial submission to the registry

March 7, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 19, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2027

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

March 7, 2024

Last Update Submit

December 17, 2025

Conditions

Keywords

RadiotherapyEquicieAdolescentPediatric

Outcome Measures

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

    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 Outcomes (10)

  • 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

  • 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)

  • 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)

  • +5 more secondary outcomes

Study Arms (1)

entire study population

OTHER
Other: Participation in 10 horse-assisted therapy sessions

Interventions

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

entire study population

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Paul Strauss

Strasbourg, 67033, France

RECRUITING

Central Study Contacts

Valérie SARTORI

CONTACT

Manon VOEGELIN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 26, 2024

Study Start

June 19, 2024

Primary Completion (Estimated)

June 19, 2027

Study Completion (Estimated)

June 19, 2027

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations