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Onco-coaching of Sport-inspired for the Social, Professional and Psychological Restoring of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells (REBOND)

2019年1月22日 更新者:Institut Paoli-Calmettes

Onco-coaching of Sport-inspired for the Social, Professional and Psychological Restoring of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells: Pilot Study

Sometimes, certain patients, while the treatment comes to an end and while a remission is possible, present psychological and emotional difficulties. The return in a " new life " is lived as a factor of often unexpected stress which force the patients, from the end of the treatment, to reconsider their future orientation, their roles and social identities, their interpersonal relations, and the quality of their life.

Often, they feel a strong feeling of isolation and a shape of social marginalization stressed by the fact that forgiveness lead automatically to a spacing of the stays to the hospital, which were for them a source of social interactions. Often incapable to deal with these negative emotional situations, they live profound depressive episodes known to be associated to a lesser survival.

The investigators think that a support of type onco-coaching of sport- inspirated could allow these survivors to find a certain quality of life to see certain well-being.

In a recent study, It was analyzed the leadership " which works " in the high-level sport in France. Five selectors of national teams of team sports were questioned about their conceptions on the best practices of management and management of the people. They grant a quite particular attention on the individual consideration of the athlete and the implementation of a relationship of trust, to the delegation of the power and the sharing regulated by the decision-making which strengthen the sportsman in a feeling of autonomy and skill, catalysts of an intrinsic motivation.

These needs were satisfied, they give meaning to the share and get a psychological well-being. The satisfaction of these needs is generally made through the realization of purposes, results wished by an action, which can sometimes enter in contradiction with the satisfaction of the fundamental needs and thus damage the well-being. The role of the coach is to help the coached to target its purposes, to decide on a strategy to affect him and keep an intact motivation throughout the process. Without being therapeutic, the questioning and the action of the coach would allow the coached to reach gradually the satisfaction of its fundamental psychological needs and thus a real well-being.

The intention is to make them benefit knowledge and expertise in the field of the coaching and by a logic of research inter disciplinary to set up steps of support individualized to propose adapted answers and assist them at best in their company on returning to the life by making a significant contribution with the patients to help them to find of the autonomy in their own decision-making, to find their social identity (refusal and discharge of positive or negative discrimination), to accompany the therapeutic education of the patient towards a stake in social reeducation and finally, to highlight and to strengthen its interests and social concerns.

In terms of public health, this approach, facilitating the transition of the treatment in the complete remission, could be subjected and so improve the quality of the services of support proposed until then.

If the hypotheses of research see each other confirmed, this device coaching of sport-inspired of the patients in remission could then be transferable in other oncologic fields.

調査の概要

研究の種類

介入

入学 (予想される)

32

段階

  • 適用できない

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。

研究場所

      • Marseille、フランス、13273
        • 募集
        • GENRE
        • コンタクト:
        • 主任研究者:
          • BLAISE Didier, MD, PhD

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

説明

Inclusion Criteria:

  • Age > 18 years and presenting a good understanding and a practice of the French language,
  • Having been treated by allogeneic transplantation of hematopoietic stem cells,
  • Written informed consent,
  • Affiliation to Social Security System.

Exclusion Criteria:

  • Patient with a graft versus host disease requiring a treatment by immunosuppressors to be controlled,
  • Patient under treatments du to complications (infections, graft versus host disease (GVHD), …),
  • Patient with evolutive hematologic disease or in relapse,
  • Patients deprived of liberty or placed Under the authority of a tutor,
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.

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

  • 主な目的:他の
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
他の:interviews and questionnaires
Realization of interviews (at day 0, and at 1, 2, 3 6 and 12 months) and questionnaires delivery (at day 0, and at 3, 6 and 12 months)
For Interviews : done at Day 0 and at 1, 2, 3, 6 and 12 months. Questionnaires : given at Day 0, and at 3, 6 and 12 months.
他の名前:
  • questionnaires given by coach

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
Estimate the patient's interest with this proposal of care
時間枠:At inclusion

The evaluation of this intervention will be the acceptance by the patient of the inclusion in this pilot study, and thus the percentage of the patients realizing the first appointment of onco-coaching.

The proposal of the sessions of coaching will be made by the doctor.

At inclusion

二次結果の測定

結果測定
メジャーの説明
時間枠
Estimate the improvement of the well-being of the patients at the stemming from the sessions of coaching by means of questionnaires questioning their feeling.
時間枠:From inclusion to month 12
Demonstrate an improvement of the feeling of personal efficiency with questionnaires (Generalized Self-Efficacy Scale)
From inclusion to month 12
Estimate the improvement of the well-being of the patients at the stemming from the sessions of coaching by means of interviews questioning their feeling.
時間枠:From inclusion to month 12
Demonstrate an improvement of the feeling of personal efficiency with interviews
From inclusion to month 12
Estimate the improvement of the well-being of the patients at the stemming from the sessions of coaching by means of interviews questioning their feeling.
時間枠:From inclusion to month 12
Demonstrate an improvement of the feeling of the hope with interviews
From inclusion to month 12
Estimate the improvement of the well-being of the patients at the stemming from the sessions of coaching by means of questionnaires questioning their feeling.
時間枠:From inclusion to month 12
Demonstrate an improvement of the feeling of the hope questionnaires (scale of the hope)
From inclusion to month 12
Estimate the improvement of the well-being of the patients at the stemming from the sessions of coaching by means of interviews questioning their feeling.
時間枠:From inclusion to month 12
Demonstrate an improvement of the feeling of the global motivation with interviews
From inclusion to month 12
Estimate the improvement of the well-being of the patients at the stemming from the sessions of coaching by means of questionnaires questioning their feeling.
時間枠:From inclusion to month 12
Demonstrate an improvement of the feeling of the global motivation with questionnaires (global motivation scale)
From inclusion to month 12
Estimate the improvement of the well-being of the patients at the stemming from the sessions of coaching by means of interviews questioning their feeling.
時間枠:From inclusion to month 12
Demonstrate an improvement of the quality of their interpersonal relations of the patients with interviews
From inclusion to month 12
Estimate the improvement of the well-being of the patients at the stemming from the sessions of coaching by means of questionnaires questioning their feeling.
時間枠:From inclusion to month 12
Demonstrate an improvement of the quality of their interpersonal relations of the patients with questionnaires (scale of the quality of the interpersonal relations)
From inclusion to month 12

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

捜査官

  • 主任研究者:BLAISE Didier, MD, PhD、Institut Paoli-Calmettes

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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)

2017年7月12日

一次修了 (予想される)

2019年7月1日

研究の完了 (予想される)

2019年12月1日

試験登録日

最初に提出

2017年8月21日

QC基準を満たした最初の提出物

2017年9月1日

最初の投稿 (実際)

2017年9月6日

学習記録の更新

投稿された最後の更新 (実際)

2019年1月23日

QC基準を満たした最後の更新が送信されました

2019年1月22日

最終確認日

2019年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • REBOND-IPC 2016-014

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

医薬品およびデバイス情報、研究文書

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Haematologic Disease (Cancer)の臨床試験

  • HuidaGene Therapeutics Co., Ltd.
    募集
  • Novartis Pharmaceuticals
    終了しました
    メラノーマ | 高度なEGFR変異体非小さな細胞肺cancer(NSCLC) | KRAS G12変異NSCLC | 食道扁平上皮がん(SCC) | ヘッド/ネックSCC | 進行した胃腸間質腫瘍(GIST) | 進行したNRAS/BRAFT WT皮膚黒色腫
    アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
  • Hemab ApS
    PSI CRO
    募集
    フォン・ヴィレブランド病(VWD) | フォン・ヴィレブランド病 (VWD)、タイプ 1 | フォンウィルブランド病(VWD)、タイプ2 | Von Willebrand Disease(VWD)、タイプ3 | フォン・ウィルブランド病、タイプ2a | Von Willebrand病、タイプ2M | Von Willebrand病、タイプ2N
    アメリカ, イギリス, オーストラリア
  • Adelphi Values LLC
    Blueprint Medicines Corporation
    完了
    肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されました
    アメリカ
  • Jonsson Comprehensive Cancer Center
    National Cancer Institute (NCI); Highlight Therapeutics
    積極的、募集していない
    平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件
    アメリカ

Interviews with coachの臨床試験

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