- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: jihane pakradouni, PhD
- 전화번호: +33491223778
- 이메일: DRCI.UP@ipc.unicancer.fr
연구 장소
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Marseille, 프랑스, 13009
- 모병
- Institut Paoli-Calmettes
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연락하다:
- Marie-anne Hospital, MD
- 전화번호: 0491227742
- 이메일: HOSPITALM@ipc.unicancer.fr
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연락하다:
- Allison Arthur
- 전화번호: 0491223448
- 이메일: arthura@ipc.unicancer.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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.
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To identify the success and failure factors of the extrahospital support program through qualitative interviews.
기간: 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
기간: 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
기간: 2 years
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Number of refusals to sign the informed consent form. |
2 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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