RadiotherapyT-QAPNCT06330142
Hippotherapy Teenager-pediatric Radiotherapy
A study testing Participation in 10 horse-assisted therapy sessions in people with Radiotherapy, run by Centre Paul Strauss at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Radiotherapy
- What is being tested?
- Participation in 10 horse-assisted therapy sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2024to 19 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Paul Strauss
Strasbourg, 67033
Valérie SARTORI, 0368767223, v.sartori@icans.eu
Manon VOEGELIN, 0368767360, promotion-rc@icans.eu
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiotherapy
- Being tested
- Participation in 10 horse-assisted therapy sessions
- Keywords
- Radiotherapy, Equicie, Adolescent, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in 10 horse-assisted therapy sessionsOther
supporting children and teenagers undergoing radiotherapy with a horse-assisted therapy approach
| Study group | Role | What they receive |
|---|---|---|
| entire study population | Other | Not described Receives: Other: Participation in 10 horse-assisted therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Parents (or carers) will complete a questionnaire to assess their child's quality of life.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: At every HAT sessions (up to 10 weeks)
Evaluate participant's expectations and satisfaction with their care
questionnaire
Measured: 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.
Measured: every week during radiotherapy (from 3 to 7 weeks)
Assessing the impact of HAT on the child during irradiation according to the MERT
Measured: 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
Measured: 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
Measured: at the end of the HAT sessions (at 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start19 Jun 2024
- Primary completion19 Jun 2027 (estimated)
- Study completion19 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330142
- Sponsor's protocol ID
- 2022-006
- Acronym
- T-QAP
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-QAP: radioTherapy eQuicie Adolescent - Pediatrics
- ClinicalTrials.gov ID
- NCT06330142
- Acronym / sponsor ID
- T-QAP / 2022-006
- Conditions
- Radiotherapy
- Keywords
- Radiotherapy, Equicie, Adolescent, Pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 19 Jun 2027 (estimated)
- Study completion
- 19 Jun 2027 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| entire study population | Other | Other: Participation in 10 horse-assisted therapy sessions |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in 10 horse-assisted therapy sessionssupporting children and teenagers undergoing radiotherapy with a horse-assisted therapy approach | Other | entire study population |
Primary outcome
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.
10 secondary outcomes
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
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
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
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)
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)
Evaluate participant's expectations and satisfaction with their care
Time frame: 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)
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)
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)
Assessing the impact of an alternative activity on parents' satisfaction with care
Time frame: at the end of the HAT sessions (at 10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in 10 horse-assisted therapy sessions in people with Radiotherapy, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie SARTORI (368767223 ext. 33, v.sartori@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.