Cancer PediatricEQUICAPNCT07515274
Evaluation of the Effects of Equicoaching on Social Reintegration Among Young Adults Who Have Been Treated for Cancer
A study testing equicoaching in people with Cancer Pediatric, run by Centre Leon Berard at 1 site in France.
Trial summary
This is a category 2 human research study (RIPH), interventional, single-center, prospective, open-label. The primary objective of this study is to qualitatively assess the effects of equicoaching on social reintegration in young adults who have been treated for cancer. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Cancer Pediatric
- What is being tested?
- equicoaching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2026to 31 Jan 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have been treated for a malignant oncological or hematological condition.
- Be between 15 and 25 years of age at the time of cancer diagnosis. This age range corresponds to that chosen by the Leon Berard Cancer Center (CLB) and the Institute of Pediatric Hematology and Oncology (IHOPe) for the Adolescents and Young Adults with Cancer (DAJAC) program
- Have been treated at IHOPe/CLB as part of the DAJAC program
- Have completed intensive treatment within the last twelve months.
- Be able to understand, read, and write French
- Be affiliated with a health insurance plan
Show all 10Show fewer
- Have been informed about the study and have given consent
- For minors:
- All of the above criteria
- Parent/legal guardian informed about the study and having given consent
Who cannot join
- Patient deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding women
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
CLB
Lyon
Amandine BERTRAND, MD, 0469166685, amandine.bertrand@ihope.fr
Amandine BERTRAND, MD
About this study
This is a category 2 human research study (RIPH), interventional, single-center, prospective, open-label.
The primary objective of this study is to qualitatively assess the effects of equicoaching on social reintegration in young adults who have been treated for cancer.
The secondary objectives are to evaluate the contribution of equicoaching to:
- Self-confidence;
- Well-being
- Quality of life Satisfaction with equicoaching will also be evaluated.
Read the detailed description
The study will be systematically offered via DAJAC referral nurses and/or the referral oncohematologist to all IHOPe patients (and their parent/legal guardian in the case of minors), in accordance with the inclusion and exclusion criteria, during follow-up consultations or during the multidisciplinary end-of-treatment day. The study team will keep a list of eligible patients to ensure the completeness of possible inclusions and the study acceptance rate. The information sheet and consent form will be provided, a reasonable reflection period will be allowed, and the investigator will answer any questions if necessary. If the patient agrees to participate, they will give their written consent by personally dating and signing the consent form (or parents will sign for minor patients). After collecting the study-specific consent form, an initial meeting will be held at the CLB between the participants and members of the project team. The purpose of this meeting is to get to know each other and create group dynamics. This initial discussion will also provide an opportunity to explain the overall objectives and outline the intervention with the participants.
An initial individual interview will be organized with each participant involved in order to discuss their experience of the disease, their social relationships, their leisure activities, their relationship with horses, and their relationship with sport, exploring their experiences and practices in physical activities. Questionnaires to assess quality of life, well-being, and self-confidence will be completed during this interview. This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions at an equestrian center in Ste Consorce (69), combined with monthly individual follow-up via videoconference.
The various group sessions will address the following topics:
- Regaining self-esteem and self-confidence
- Identifying and understanding motivational factors
- Aligning thoughts, feelings, and emotions
- Overcoming doubts and fears, moving forward
- Setting one or more goals and translating them into an action plan
- Taking action to achieve your goal These sessions will take place in an equestrian arena and will consist of exercises in small groups, interacting with one or more horses. For example, the AJAs will have to guide the horses over an obstacle course using their voice, touch, and/or sound effects. After each exercise, there will be a debriefing with the equicoaches, during which the AJAs will be asked to share their feelings/impressions about their experience and discuss those of the other participants. Following each group session (15 days later), the AJAs will have individual interviews with one of the equicoaches. These interviews will provide an opportunity to explore certain topics discussed in the group sessions in greater depth, as well as to explore new topics related to the AJAs' expectations and the themes previously discussed. This personalized approach will also provide a link between the different equicoaching sessions and allow for adjustments to be made to the content and the situations in which it is practiced.Finally, at the end of the intervention, a second individual interview will be organized to review its benefits.During the various meetings with members of the EQUICAP team, if a participant shows high levels of anxiety or depression, or any other behavior and/or speech that seems alarming, it has been agreed that the principal investigator will be informed as soon as possible so that the necessary measures can be taken (referral to a specialist belonging to the IHOPe/CLB structure or a private practitioner). Semi-structured individual interviews before and after the intervention on various topics (the course of the disease, the ability to plan for the future, independence, social relationships, and perceptions of equicoaching). The following questionnaires will be completed by participants at various stages of the study: 1) Self-confidence will be measured using Rosenberg's self-esteem scale.It consists of 10 statements about self-esteem, which respondents must rate on a Likert scale ranging from "strongly disagree" to "strongly agree." The scale assesses overall self-esteem, including aspects such as personal satisfaction, self-confidence, and self-evaluation. Measurements will be taken during the initial (T2) and final (T4) individual interviews. 2) Well-being will be measured using the Warwick Edinburgh Mental Well-being Scale (WEMWBS). This scale consists of 14 statements that assess positive aspects of mental well-being, such as feelings of happiness, optimism, and vitality. Respondents indicate their agreement with each statement on a Likert-type scale ranging from "not at all" to "very often." Measurements will be taken during the initial (T2) and final (T4) individual interviews. 3) Quality of life will be measured using the emotional functioning dimension of the PedsQL (Pediatric Quality of Life Inventory Generic Core Scales) quality of life questionnaire. It assesses four areas: physical, emotional, social, and academic well-being.Measurements will be taken during the initial (T2) and final (T4) individual interviews.Finally, satisfaction with Equicoaching will be assessed using a self-administered questionnaire at the end of the intervention (T4).
- Conditions
- Cancer Pediatric
- Being tested
- equicoaching
- Keywords
- cancer pediatric
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
equicoachingProcedure or surgery
An initial individual interview will be organized with each participant to discuss their experience of the disease, their social relationships, their leisure activities, their relationship with horses, and their relationship with sports, exploring their experiences and practices in physical activities. Questionnaires to assess quality of life, well-being, and self-confidence will be completed during this interview.
This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions combined with individual follow-up. This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions combined with monthly individual follow-up via videoconference. The various group sessions will address different topics.
After each group session, the AJAs will have individual i
| Study group | Role | What they receive |
|---|---|---|
| intervention EQUICAP | Experimental | Not described Receives: Procedure: equicoaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
social reintegration
Social reintegration will be assessed using a qualitative comparative analysis of two individual semi-structured interviews conducted at baseline and six months after the intervention.
Interview topics will include illness trajectory, social and family relationships, level of autonomy and independence, ability to plan for the future, social participation, and participants' perceptions of the equicoaching intervention.
All interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis with NVivo software to identify changes in themes and subthemes over time.
Measured: Inclusion and month 6
Secondary outcomes (3)
Self-confidence
Self-esteem will be measured using the Rosenberg Self-Esteem Scale, a 10-item self-administered questionnaire.Total scores range from 10 to 40, with higher scores indicating better self-esteem.
Measured: Inclusion and month 6
Well-being
Mental well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), a 14-item self-administered questionnaire measuring positive aspects of mental health.Total scores range from 14 to 70, with higher scores indicating better mental well-being.
Measured: Inclusion and month 6
emotional functioning subscale of Quality of life
Emotional functioning will be measured using the Emotional Functioning subscale of the Pediatric Quality of Life Inventory (PedsQL).The subscale consists of 5 items assessing emotional difficulties. Items are scored on a 5-point Likert scale and transformed to a 0-100 scale, with higher scores indicating better emotional functioning.
Measured: Inclusion and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start5 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PediatricStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515274
- Sponsor's protocol ID
- ET25-219 (EQUICAP)
- Acronym
- EQUICAP
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Equicoaching on Social Reintegration Among Young Adults Who Have Been Treated for Cancer
- ClinicalTrials.gov ID
- NCT07515274
- Acronym / sponsor ID
- EQUICAP / ET25-219 (EQUICAP)
- Conditions
- Cancer Pediatric
- Keywords
- cancer pediatric
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 Apr 2026 (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 is a category 2 human research study (RIPH), interventional, single-center, prospective, open-label.
The primary objective of this study is to qualitatively assess the effects of equicoaching on social reintegration in young adults who have been treated for cancer.
The secondary objectives are to evaluate the contribution of equicoaching to:
- Self-confidence;
- Well-being
- Quality of life Satisfaction with equicoaching will also be evaluated.
Detailed description
The study will be systematically offered via DAJAC referral nurses and/or the referral oncohematologist to all IHOPe patients (and their parent/legal guardian in the case of minors), in accordance with the inclusion and exclusion criteria, during follow-up consultations or during the multidisciplinary end-of-treatment day. The study team will keep a list of eligible patients to ensure the completeness of possible inclusions and the study acceptance rate. The information sheet and consent form will be provided, a reasonable reflection period will be allowed, and the investigator will answer any questions if necessary. If the patient agrees to participate, they will give their written consent by personally dating and signing the consent form (or parents will sign for minor patients). After collecting the study-specific consent form, an initial meeting will be held at the CLB between the participants and members of the project team. The purpose of this meeting is to get to know each other and create group dynamics. This initial discussion will also provide an opportunity to explain the overall objectives and outline the intervention with the participants.
An initial individual interview will be organized with each participant involved in order to discuss their experience of the disease, their social relationships, their leisure activities, their relationship with horses, and their relationship with sport, exploring their experiences and practices in physical activities. Questionnaires to assess quality of life, well-being, and self-confidence will be completed during this interview. This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions at an equestrian center in Ste Consorce (69), combined with monthly individual follow-up via videoconference.
The various group sessions will address the following topics:
- Regaining self-esteem and self-confidence
- Identifying and understanding motivational factors
- Aligning thoughts, feelings, and emotions
- Overcoming doubts and fears, moving forward
- Setting one or more goals and translating them into an action plan
- Taking action to achieve your goal These sessions will take place in an equestrian arena and will consist of exercises in small groups, interacting with one or more horses. For example, the AJAs will have to guide the horses over an obstacle course using their voice, touch, and/or sound effects. After each exercise, there will be a debriefing with the equicoaches, during which the AJAs will be asked to share their feelings/impressions about their experience and discuss those of the other participants. Following each group session (15 days later), the AJAs will have individual interviews with one of the equicoaches. These interviews will provide an opportunity to explore certain topics discussed in the group sessions in greater depth, as well as to explore new topics related to the AJAs' expectations and the themes previously discussed. This personalized approach will also provide a link between the different equicoaching sessions and allow for adjustments to be made to the content and the situations in which it is practiced.Finally, at the end of the intervention, a second individual interview will be organized to review its benefits.During the various meetings with members of the EQUICAP team, if a participant shows high levels of anxiety or depression, or any other behavior and/or speech that seems alarming, it has been agreed that the principal investigator will be informed as soon as possible so that the necessary measures can be taken (referral to a specialist belonging to the IHOPe/CLB structure or a private practitioner). Semi-structured individual interviews before and after the intervention on various topics (the course of the disease, the ability to plan for the future, independence, social relationships, and perceptions of equicoaching). The following questionnaires will be completed by participants at various stages of the study: 1) Self-confidence will be measured using Rosenberg's self-esteem scale.It consists of 10 statements about self-esteem, which respondents must rate on a Likert scale ranging from "strongly disagree" to "strongly agree." The scale assesses overall self-esteem, including aspects such as personal satisfaction, self-confidence, and self-evaluation. Measurements will be taken during the initial (T2) and final (T4) individual interviews. 2) Well-being will be measured using the Warwick Edinburgh Mental Well-being Scale (WEMWBS). This scale consists of 14 statements that assess positive aspects of mental well-being, such as feelings of happiness, optimism, and vitality. Respondents indicate their agreement with each statement on a Likert-type scale ranging from "not at all" to "very often." Measurements will be taken during the initial (T2) and final (T4) individual interviews. 3) Quality of life will be measured using the emotional functioning dimension of the PedsQL (Pediatric Quality of Life Inventory Generic Core Scales) quality of life questionnaire. It assesses four areas: physical, emotional, social, and academic well-being.Measurements will be taken during the initial (T2) and final (T4) individual interviews.Finally, satisfaction with Equicoaching will be assessed using a self-administered questionnaire at the end of the intervention (T4).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention EQUICAP | Experimental | Procedure: equicoaching |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Have been treated for a malignant oncological or hematological condition.
- Be between 15 and 25 years of age at the time of cancer diagnosis. This age range corresponds to that chosen by the Leon Berard Cancer Center (CLB) and the Institute of Pediatric Hematology and Oncology (IHOPe) for the Adolescents and Young Adults with Cancer (DAJAC) program
- Have been treated at IHOPe/CLB as part of the DAJAC program
- Have completed intensive treatment within the last twelve months.
- Be able to understand, read, and write French
Key exclusion criteria (2 listed)
- Patient deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding women
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 |
|---|---|---|
| equicoachingAn initial individual interview will be organized with each participant to discuss their experience of the disease, their social relationships, their leisure activities, their relationship with horses, and their relationship with sports, exploring their experiences and practices in physical activities. Questionnaires to assess quality of life, well-being, and self-confidence will be completed during this interview. This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions combined with individual follow-up. This will be followed by equicoaching. This intervention will be carried out by two qualified professionals over a period of six months and will consist of six monthly group sessions combined with monthly individual follow-up via videoconference. The various group sessions will address different topics. After each group session, the AJAs will have individual i | Procedure or surgery | intervention EQUICAP |
Primary outcome
social reintegration
Time frame: Inclusion and month 6
Social reintegration will be assessed using a qualitative comparative analysis of two individual semi-structured interviews conducted at baseline and six months after the intervention. Interview topics will include illness trajectory, social and family relationships, level of autonomy and independence, ability to plan for the future, social participation, and participants' perceptions of the equicoaching intervention. All interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis with NVivo software to identify changes in themes and subthemes over time.
3 secondary outcomes
Self-confidence
Time frame: Inclusion and month 6
Well-being
Time frame: Inclusion and month 6
emotional functioning subscale of Quality of life
Time frame: Inclusion and month 6
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 13 Apr 2026.
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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 equicoaching in people with Cancer Pediatric, run by Centre Leon Berard 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 10 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Apr 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
social reintegration (time frame: Inclusion and month 6). 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 13 Apr 2026.