Hippotherapy Teenager-pediatric Radiotherapy (T-QAP)

March 18, 2024 updated by: Institut de cancérologie Strasbourg Europe

T-QAP: radioTherapy eQuicie Adolescent - Pediatrics

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67033
        • Institut de cancerologie Strasbourg Europe
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura BOINOT-FRITSCH
        • Sub-Investigator:
          • Georges NOEL
        • Sub-Investigator:
          • Claire DOSSUN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: entire study population
Other: Participation in 10 horse-assisted therapy sessions
supporting children and teenagers undergoing radiotherapy with a horse-assisted therapy approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measure
Measure Description
Time Frame
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.
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
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)
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
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)
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
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
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
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.
At every HAT sessions (up to 10 weeks)
Evaluate participant's expectations and satisfaction with their care
Time Frame: at the beginning and end of HAT sessions (up to 10 weeks)
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
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.
every week during radiotherapy (from 3 to 7 weeks)
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)
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
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
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
Time Frame: at the end of the HAT sessions (at 10 weeks)
Open questionnaire at the end of HAT to be completed by parents
at the end of the HAT sessions (at 10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de cancérologie Strasbourg Europe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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