Evaluation of the Effects of Equicoaching on Social Reintegration Among Young Adults Who Have Been Treated for Cancer (EQUICAP)

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:

1. Self-confidence;
2. Well-being
3. Quality of life Satisfaction with equicoaching will also be evaluated.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Pediatric
• Intervention / Treatment: Procedure: equicoaching

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:

1. Regaining self-esteem and self-confidence
2. Identifying and understanding motivational factors
3. Aligning thoughts, feelings, and emotions
4. Overcoming doubts and fears, moving forward
5. Setting one or more goals and translating them into an action plan
6. 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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • CLB
    • Principal Investigator: Amandine BERTRAND, MD
    • Contact: Amandine BERTRAND, MD; Phone Number: 0469166685; Email: amandine.bertrand@ihope.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• Patient deprived of liberty by judicial or administrative decision
• Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: intervention EQUICAP

Procedure: equicoaching; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Inclusion and month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Inclusion and month 6

Collaborators and Investigators

• Sponsor: Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cancer pediatric
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ET25-219 (EQUICAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No