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)

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.

Study Overview

• Status: Unknown
• Conditions: Haematologic Disease (Cancer); Onco-coaching of Sport- Inspirated
• Intervention / Treatment: Other: Interviews with coach

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13273
    • Recruiting
    • GENRE
    • Contact: COURNIER Sandra; Phone Number: 33 (0) 4 91 22 37 78; Email: drci.up@ipc.unicancer.fr
    • Principal Investigator: BLAISE Didier, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)	Other: Interviews with coach; 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.; Other Names: questionnaires given by coach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	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.	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.	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.	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.	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.	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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: BLAISE Didier, MD, PhD, Institut Paoli-Calmettes

Publications and helpful links

Helpful Links

• Institut PAOLI-CALMETTES

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: REBOND-IPC 2016-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No