- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07861971
Feasibility Study of a Sports-Inspired Onco-Coaching Progranm for Young Adults i Cancer Remission (rebond-jas)
REBOND JAS: Feasibility Study of a Sport-Inspired Onco-Coaching Program for Young Adults in Cancer Remission: Rebond-JAs-IPC 2025-017
This is a single-center, non-randomized feasibility study. For this study, 19 young adults treated for cancer at the Paoli-Calmettes Institute will be included.This study includes interviews and questionnaires to assess the adherence rate. It will be measured by the percentage of patients who attend the first two coaching sessions (either in person or via videoconference) relative to the total number of patients included in the study.
The invitation to participate in this program will be made by the surgeon, hematologist, oncologist, or radiation therapist.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The first coaching session must take place within one month following inclusion. Coaching sessions will involve all patients enrolled in the study.
Coaching sessions with the coach will be offered as monthly individual interviews over a period ranging from 2 to 6 months. The frequency of sessions will be co-determined by the coach and the participant, depending on the participant's needs. The coach will aim to schedule sessions with at least one month between them. Therefore, patients will have a minimum of 2 and a maximum of 6 onco-coaching sessions.
Sessions will be held at the Faculty of Sports Sciences, in a dedicated office. The first session must be conducted in person. Subsequent sessions may be conducted remotely (by phone or videoconference), depending on patient preferences. This option is supported by findings from recent studies (McCann et al., 2019; Mostafa et al., 2025; Zhong et al., 2025).
During sessions, the coach uses standard motivational interviewing techniques (Miller, 1983). Through the use of open-ended questions, active and reflective listening, positive reinforcement and validation techniques, as well as regular reformulation of what is expressed, the coach reveals contradictions and ambivalence, defuses resistance, and promotes self-determined strategies for change (Miller and Rollnick, 2002).
From the first session, the coach works with each participant to define personalized goals and a strategy to achieve them, including identifying available resources. Each session should last between 45 minutes and 1 hour.Questionnaires:
QEEC-AYAs: A tool designed to measure the psychosocial needs of adolescents and young adults during and after treatment. Developed by Justafré et al. (2023), it includes 48 items divided into 7 dimensions: information (8 items), care team (6 items), physical health (4 items), emotional health (14 items), sexual and reproductive health (6 items), health behaviors and well-being (4 items), and daily life (6 items). The questionnaire demonstrates strong psychometric properties, with Cronbach's alpha values above 0.80.
Interviews:
These semi-structured interviews will be conducted to analyze the impact of the intervention on patients and to better understand the underlying processes. They will be carried out by researchers specialized in social psychology and quantitative data analysis, using a semi-structured adaptive interview guide. Each interview will last between 30 minutes and 1 hour.
The first semi-structured interview will be conducted in a room at the Faculty of Sports Sciences by at least two researchers. The second interview may be conducted either remotely or in person at the Faculty of Sports Sciences.
All interviews must be recorded using a voice recorder, then pseudonymized (only the study ID number) and transferred to the secure server of the Management Sport Cancer laboratory. The recordings must then be deleted from the voice recorder.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: jihane pakradouni, PhD
- Numéro de téléphone: +33491223778
- E-mail: DRCI.UP@ipc.unicancer.fr
Lieux d'étude
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Marseille, France, 13009
- Recrutement
- Institut Paoli-Calmettes
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Contact:
- Marie-anne Hospital, MD
- Numéro de téléphone: 0491227742
- E-mail: HOSPITALM@ipc.unicancer.fr
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Contact:
- Allison Arthur
- Numéro de téléphone: 0491223448
- E-mail: arthura@ipc.unicancer.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Male or female aged 18 to 25 at the time of cancer diagnosis and/or at the time of inclusion.In complete remission, within one year following the end of treatment and at the time of inclusion
La description
Inclusion Criteria:
- Male or female aged 18 to 25 at the time of cancer diagnosis and/or at the time of inclusion.
- In complete remission, within one year following the end of treatment and at the time of inclusion.
- Treated at the Comprehensive Cancer Center Institut Paoli-Calmettes.
- Able to speak and write in French.
- Has not objected to participation in the study.
- Affiliated with a social security scheme or beneficiary of such a scheme.
Non -Inclusion Criteria:
- Patient undergoing treatment, except for maintenance therapy.
- Patient experiencing a relapse.
- Person in an emergency situation, legally protected adult (under guardianship, curatorship, or judicial protection), or unable to express non-opposition.
- Patient with clinically confirmed psychological symptoms (e.g., receiving antidepressants, mood stabilizers, anxiolytics, etc.).
- Inability to comply with study follow-up due to geographic, social, or psychological reasons.
Exclusion Criteria:
Relapse occurring between inclusion and the second onco-coaching session.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The primary objective of the study is to assess the feasibility of a sport-inspired onco-coaching program by evaluating the participation rate of young adults in the first two coaching sessions.
Délai: 2 years
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The primary evaluation criterion of the study will be the adherence rate to the onco-coaching program. It will be measured by the percentage of patients who attend the first two coaching sessions (either in person or via videoconference) relative to the total number of patients enrolled in the study. The invitation to participate in the program will be made by the surgeon, hematologist, oncologist, or radiation therapist. |
2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To identify the success and failure factors of the extrahospital support program through qualitative interviews.
Délai: 2 years
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Assessment of participants' satisfaction with the program through semi-structured interviews |
2 years
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To evaluate overall adherence to the onco-coaching program
Délai: 2 years
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Compliance with the onco-coaching program, measured empirically across all scheduled visits by assigning equal weight to all participants, regardless of the number of visits planned. |
2 years
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To collect and characterize the reasons why patients decline to participate in the study
Délai: 2 years
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Number of refusals to sign the informed consent form. |
2 years
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Rebond-JAs-IPC 2025-017
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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