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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)

Primary Purpose

Haematologic Disease (Cancer), Onco-coaching of Sport- Inspirated

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interviews with coach
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Haematologic Disease (Cancer)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GENRERecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

interviews and questionnaires

Arm Description

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)

Outcomes

Primary Outcome Measures

Estimate the patient's interest with this proposal of care
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.

Secondary Outcome Measures

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.
Demonstrate an improvement of the feeling of personal efficiency with questionnaires (Generalized Self-Efficacy Scale)
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.
Demonstrate an improvement of the feeling of personal efficiency with interviews
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.
Demonstrate an improvement of the feeling of the hope with interviews
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.
Demonstrate an improvement of the feeling of the hope questionnaires (scale of the hope)
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.
Demonstrate an improvement of the feeling of the global motivation with interviews
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.
Demonstrate an improvement of the feeling of the global motivation with questionnaires (global motivation scale)
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.
Demonstrate an improvement of the quality of their interpersonal relations of the patients with interviews
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.
Demonstrate an improvement of the quality of their interpersonal relations of the patients with questionnaires (scale of the quality of the interpersonal relations)

Full Information

First Posted
August 21, 2017
Last Updated
January 22, 2019
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT03272789
Brief Title
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
Acronym
REBOND
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haematologic Disease (Cancer), Onco-coaching of Sport- Inspirated

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interviews and questionnaires
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Interviews with coach
Other Intervention Name(s)
questionnaires given by coach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Estimate the patient's interest with this proposal of care
Description
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.
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
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.
Description
Demonstrate an improvement of the feeling of personal efficiency with questionnaires (Generalized Self-Efficacy Scale)
Time Frame
From inclusion to month 12
Title
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.
Description
Demonstrate an improvement of the feeling of personal efficiency with interviews
Time Frame
From inclusion to month 12
Title
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.
Description
Demonstrate an improvement of the feeling of the hope with interviews
Time Frame
From inclusion to month 12
Title
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.
Description
Demonstrate an improvement of the feeling of the hope questionnaires (scale of the hope)
Time Frame
From inclusion to month 12
Title
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.
Description
Demonstrate an improvement of the feeling of the global motivation with interviews
Time Frame
From inclusion to month 12
Title
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.
Description
Demonstrate an improvement of the feeling of the global motivation with questionnaires (global motivation scale)
Time Frame
From inclusion to month 12
Title
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.
Description
Demonstrate an improvement of the quality of their interpersonal relations of the patients with interviews
Time Frame
From inclusion to month 12
Title
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.
Description
Demonstrate an improvement of the quality of their interpersonal relations of the patients with questionnaires (scale of the quality of the interpersonal relations)
Time Frame
From inclusion to month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GENRE Dominique, MD
Phone
33 (0) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
COURNIER Sandra
Phone
33 (0) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BLAISE Didier, MD, PhD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
GENRE
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
COURNIER Sandra
Phone
33 (0) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
BLAISE Didier, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.institutpaolicalmettes.fr
Description
Institut PAOLI-CALMETTES

Learn more about this trial

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

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