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Haematologic Disease (Cancer)REBONDNCT03272789

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

A study testing Interviews with coach in people with Haematologic Disease (Cancer) and Onco-coaching of Sport- Inspirated, run by Institut Paoli-Calmettes at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Interviews with coach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteFrance
Study dates
12 Jul 2017to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • GENRE

    Marseille, 13273

    COURNIER Sandra, 33 (0) 4 91 22 37 78, drci.up@ipc.unicancer.fr

    BLAISE Didier, MD, PhD

    Recruiting

Other trials in France

About this study

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

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.

Read more

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.

Being tested
Interviews with coach
Medical subject headings
Hematologic Diseases, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interviews with coachOther

    Also called questionnaires given by 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.

Study groups in NCT03272789
Study groupRoleWhat they receive
interviews and questionnairesOtherRealization 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)
Receives: Other: Interviews with coach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At inclusion

Secondary outcomes (8)
  1. 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)

    Measured: From inclusion to month 12

  2. 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

    Measured: From inclusion to month 12

  3. 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

    Measured: From inclusion to month 12

  4. 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)

    Measured: From inclusion to month 12

  5. 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

    Measured: From inclusion to month 12

  6. 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)

    Measured: From inclusion to month 12

  7. 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

    Measured: From inclusion to month 12

  8. 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)

    Measured: From inclusion to month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2017
  2. Study start12 Jul 2017
  3. Primary completionJul 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03272789
Sponsor's protocol ID
REBOND-IPC 2016-014
Acronym
REBOND
Status last verified
Jan 2019
First submitted
21 Aug 2017
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Interviews with coach in people with Haematologic Disease (Cancer) and Onco-coaching of Sport- Inspirated, run by Institut Paoli-Calmettes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact GENRE Dominique, MD (33 (0) 4 91 22 37 78, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the patient's interest with this proposal of care (time frame: At inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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