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Feasibility Study of a Sports-Inspired Onco-Coaching Progranm for Young Adults i Cancer Remission (rebond-jas)

2026年10月1日 更新者:Institut Paoli-Calmettes

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.

調査の概要

状態

募集

詳細な説明

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.

研究の種類

観察的

入学 (推定)

19

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:OTHER
  • 時間の展望:PROSPECTIVE

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
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.
時間枠:2 years

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

二次結果の測定

結果測定
メジャーの説明
時間枠
To identify the success and failure factors of the extrahospital support program through qualitative interviews.
時間枠:2 years

Assessment of participants' satisfaction with the program through semi-structured interviews

2 years
To evaluate overall adherence to the onco-coaching program
時間枠:2 years

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
To collect and characterize the reasons why patients decline to participate in the study
時間枠:2 years

Number of refusals to sign the informed consent form.

2 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月3日

一次修了 (推定)

2028年8月3日

研究の完了 (推定)

2028年8月3日

試験登録日

最初に提出

2026年9月25日

QC基準を満たした最初の提出物

2026年10月1日

最初の投稿 (実際)

2026年10月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年10月1日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Rebond-JAs-IPC 2025-017

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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