<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272789</url>
  </required_header>
  <id_info>
    <org_study_id>REBOND-IPC 2016-014</org_study_id>
    <nct_id>NCT03272789</nct_id>
  </id_info>
  <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</brief_title>
  <acronym>REBOND</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sometimes, certain patients, while the treatment comes to an end and while a remission is&#xD;
      possible, present psychological and emotional difficulties. The return in a &quot; new life &quot; is&#xD;
      lived as a factor of often unexpected stress which force the patients, from the end of the&#xD;
      treatment, to reconsider their future orientation, their roles and social identities, their&#xD;
      interpersonal relations, and the quality of their life.&#xD;
&#xD;
      Often, they feel a strong feeling of isolation and a shape of social marginalization stressed&#xD;
      by the fact that forgiveness lead automatically to a spacing of the stays to the hospital,&#xD;
      which were for them a source of social interactions. Often incapable to deal with these&#xD;
      negative emotional situations, they live profound depressive episodes known to be associated&#xD;
      to a lesser survival.&#xD;
&#xD;
      The investigators think that a support of type onco-coaching of sport- inspirated could allow&#xD;
      these survivors to find a certain quality of life to see certain well-being.&#xD;
&#xD;
      In a recent study, It was analyzed the leadership &quot; which works &quot; in the high-level sport in&#xD;
      France. Five selectors of national teams of team sports were questioned about their&#xD;
      conceptions on the best practices of management and management of the people. They grant a&#xD;
      quite particular attention on the individual consideration of the athlete and the&#xD;
      implementation of a relationship of trust, to the delegation of the power and the sharing&#xD;
      regulated by the decision-making which strengthen the sportsman in a feeling of autonomy and&#xD;
      skill, catalysts of an intrinsic motivation.&#xD;
&#xD;
      These needs were satisfied, they give meaning to the share and get a psychological&#xD;
      well-being. The satisfaction of these needs is generally made through the realization of&#xD;
      purposes, results wished by an action, which can sometimes enter in contradiction with the&#xD;
      satisfaction of the fundamental needs and thus damage the well-being. The role of the coach&#xD;
      is to help the coached to target its purposes, to decide on a strategy to affect him and keep&#xD;
      an intact motivation throughout the process. Without being therapeutic, the questioning and&#xD;
      the action of the coach would allow the coached to reach gradually the satisfaction of its&#xD;
      fundamental psychological needs and thus a real well-being.&#xD;
&#xD;
      The intention is to make them benefit knowledge and expertise in the field of the coaching&#xD;
      and by a logic of research inter disciplinary to set up steps of support individualized to&#xD;
      propose adapted answers and assist them at best in their company on returning to the life by&#xD;
      making a significant contribution with the patients to help them to find of the autonomy in&#xD;
      their own decision-making, to find their social identity (refusal and discharge of positive&#xD;
      or negative discrimination), to accompany the therapeutic education of the patient towards a&#xD;
      stake in social reeducation and finally, to highlight and to strengthen its interests and&#xD;
      social concerns.&#xD;
&#xD;
      In terms of public health, this approach, facilitating the transition of the treatment in the&#xD;
      complete remission, could be subjected and so improve the quality of the services of support&#xD;
      proposed until then.&#xD;
&#xD;
      If the hypotheses of research see each other confirmed, this device coaching of&#xD;
      sport-inspired of the patients in remission could then be transferable in other oncologic&#xD;
      fields.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate the patient's interest with this proposal of care</measure>
    <time_frame>At inclusion</time_frame>
    <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.&#xD;
The proposal of the sessions of coaching will be made by the doctor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From inclusion to month 12</time_frame>
    <description>Demonstrate an improvement of the feeling of personal efficiency with questionnaires (Generalized Self-Efficacy Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From inclusion to month 12</time_frame>
    <description>Demonstrate an improvement of the feeling of personal efficiency with interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From inclusion to month 12</time_frame>
    <description>Demonstrate an improvement of the feeling of the hope with interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From inclusion to month 12</time_frame>
    <description>Demonstrate an improvement of the feeling of the hope questionnaires (scale of the hope)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From inclusion to month 12</time_frame>
    <description>Demonstrate an improvement of the feeling of the global motivation with interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From inclusion to month 12</time_frame>
    <description>Demonstrate an improvement of the feeling of the global motivation with questionnaires (global motivation scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From inclusion to month 12</time_frame>
    <description>Demonstrate an improvement of the quality of their interpersonal relations of the patients with interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>From inclusion to month 12</time_frame>
    <description>Demonstrate an improvement of the quality of their interpersonal relations of the patients with questionnaires (scale of the quality of the interpersonal relations)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Haematologic Disease (Cancer)</condition>
  <condition>Onco-coaching of Sport- Inspirated</condition>
  <arm_group>
    <arm_group_label>interviews and questionnaires</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interviews with coach</intervention_name>
    <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.</description>
    <arm_group_label>interviews and questionnaires</arm_group_label>
    <other_name>questionnaires given by coach</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years and presenting a good understanding and a practice of the French&#xD;
             language,&#xD;
&#xD;
          -  Having been treated by allogeneic transplantation of hematopoietic stem cells,&#xD;
&#xD;
          -  Written informed consent,&#xD;
&#xD;
          -  Affiliation to Social Security System.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a graft versus host disease requiring a treatment by immunosuppressors to&#xD;
             be controlled,&#xD;
&#xD;
          -  Patient under treatments du to complications (infections, graft versus host disease&#xD;
             (GVHD), …),&#xD;
&#xD;
          -  Patient with evolutive hematologic disease or in relapse,&#xD;
&#xD;
          -  Patients deprived of liberty or placed Under the authority of a tutor,&#xD;
&#xD;
          -  Any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the study protocol or follow-up schedule.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BLAISE Didier, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>GENRE Dominique, MD</last_name>
    <phone>33 (0) 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>COURNIER Sandra</last_name>
    <phone>33 (0) 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GENRE</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>COURNIER Sandra</last_name>
      <phone>33 (0) 4 91 22 37 78</phone>
      <email>drci.up@ipc.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>BLAISE Didier, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.institutpaolicalmettes.fr</url>
    <description>Institut PAOLI-CALMETTES</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272789
org study id: REBOND-IPC 2016-014
nct id: NCT03272789
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Estimate the patient's interest with this proposal of care
time frame: At inclusion
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.
measure: 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.
time frame: From inclusion to month 12
description: Demonstrate an improvement of the feeling of personal efficiency with questionnaires (Generalized Self-Efficacy Scale)
measure: 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.
time frame: From inclusion to month 12
description: Demonstrate an improvement of the feeling of personal efficiency with interviews
measure: 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.
time frame: From inclusion to month 12
description: Demonstrate an improvement of the feeling of the hope with interviews
measure: 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.
time frame: From inclusion to month 12
description: Demonstrate an improvement of the feeling of the hope questionnaires (scale of the hope)
measure: 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.
time frame: From inclusion to month 12
description: Demonstrate an improvement of the feeling of the global motivation with interviews
measure: 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.
time frame: From inclusion to month 12
description: Demonstrate an improvement of the feeling of the global motivation with questionnaires (global motivation scale)
measure: 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.
time frame: From inclusion to month 12
description: Demonstrate an improvement of the quality of their interpersonal relations of the patients with interviews
measure: 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.
time frame: From inclusion to month 12
description: Demonstrate an improvement of the quality of their interpersonal relations of the patients with questionnaires (scale of the quality of the interpersonal relations)
arm group label: interviews and questionnaires
arm group type: Other
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: Interviews with coach
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.
arm group label: interviews and questionnaires
other name: questionnaires given by coach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: BLAISE Didier, MD, PhD
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
last name: GENRE Dominique, MD
phone: 33 (0) 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
last name: COURNIER Sandra
phone: 33 (0) 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
url: http://www.institutpaolicalmettes.fr
description: Institut PAOLI-CALMETTES
responsible party type: Sponsor
mesh term: Hematologic Diseases
sharing ipd: No