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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)

2019년 1월 22일 업데이트: 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.

연구 개요

연구 유형

중재적

등록 (예상)

32

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Marseille, 프랑스, 13273
        • 모병
        • GENRE
        • 연락하다:
        • 수석 연구원:
          • BLAISE Didier, MD, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 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.
다른 이름들:
  • questionnaires given by coach

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Estimate the patient's interest with this proposal of care
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: BLAISE Didier, MD, PhD, Institut Paoli-Calmettes

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 7월 12일

기본 완료 (예상)

2019년 7월 1일

연구 완료 (예상)

2019년 12월 1일

연구 등록 날짜

최초 제출

2017년 8월 21일

QC 기준을 충족하는 최초 제출

2017년 9월 1일

처음 게시됨 (실제)

2017년 9월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 1월 22일

마지막으로 확인됨

2019년 1월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • REBOND-IPC 2016-014

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Haematologic Disease (Cancer)에 대한 임상 시험

Interviews with coach에 대한 임상 시험

3
구독하다