Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells

Study Overview
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Brief Summary
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To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).

Detailed Description
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After signing the consent form and validating the inclusion and non-inclusion criteria, patients will be included in the study. They will be randomized unequally (2:1) into one of the study groups: OC (Onco-Coaching) group: patients will undergo onco-coaching sessions at a rate of 1 session/month until 6 months post-inclusion (M9/R6). 73 patients will be randomized in this group Group C (Control): Patients will not receive onco-coaching follow-up, but will be able to benefit from classical management in full autonomy. 35 patients will be randomized in this group

Official Title
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Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells : a Randomized Controlled Trial REBOND2-IPC 2022-009

Conditions
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Hematological Cancer

Intervention / Treatment
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* Other: interviews with coachs, semi-structured interviews and questionnaires
* Other: semi-structured interviews and questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age and have a good understanding and practice of the French language, Have been treated by an allogeneic hematopoietic stem cell transplant Signed consent to participate, Affiliation with a social security plan, or beneficiary of such a plan. Exclusion Criteria: Patients under treatment for complications (infections, GvHD,...) except patients with cGvHD requiring corticosteroid therapy less than or equal to 1 mg/kg daily Patient with progressive or relapsing hematological disease, Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express his/her consent, Person requiring psychotherapeutic care Impossibility to submit to the follow-up of the trial for geographical, social or psychological reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: They will be randomized unequally (2:1) into one of the study groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Groupe OC (Onco-Coaching)<br>You will be offered 6 coaching sessions at a rate of one session per month. The first session will take place in the month following your inclusion in the study. The study also includes the evaluation, by quality of life questionnaires, of the well-being variables (Self-efficacy, Capabilities, PANAS and Life Satisfaction, Hope, Anxiety and Depression in hospital, Subjective well-being and Health benefit). They should be completed at the time of inclusion in the protocol at 1, 3, 6, 9 and 12 months after inclusion. The purpose of these interviews is to ask more specific questions about the impact of the program. | Other: interviews with coachs, semi-structured interviews and questionnaires<br>* You will be offered 6 coaching sessions at a rate of one session per month and the first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12. Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant)<br>|
| Active Comparator: Groupe C (Contrôle)<br>the patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm. | Other: semi-structured interviews and questionnaires<br>* The first interview will be conducted on the day of inclusion or within one month of inclusion, the others will take place at R6 and R12.Questionnaires will be administered on the day of inclusion and then at R1, R6, R9 and R12. RO is the day of inclusion and it corresponds to M3 (3 months post transplant)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12). | evolution over time of the FACT-BMT( Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score during the first 15 months after transplantation the highest score corresponds to a worse condition of the patient.the value are between 0 and 200 | from inclusion(RO=M3) to R12( Month 15 =12 month post inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the impact of a coaching program on patient quality of life sub-dimensions 15 months post-transplant (M15/R12). | evolution of the FACT-BMT(Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score up to R12 evolution over time of sub-scores related to physical well-being, social well-being, functional well-being and relationship with the physician.the quality of life is a questionnaire with scores ranging from 5 to 20 | from inclusion(RO=M3) to R12(Month15 =12 month post inclusion) | 
| Measure the impact of a coaching program on the patient's empowerment (capabilities, subjective well-being, hope and self-efficacy). | evolution over time of self-efficacy (the higher the score, the better the efficiency), capability, subjective well-being and hope scores | from inclusion(RO=M3) to R12(Month15 =12 month post inclusion) | 
| Measure the impact of a coaching program on reducing emotional distress. | changes over time in HADS scores (Hospital Anxiety and Depression Scale)the highest score corresponds to high anxiety and depression the value are between 0 and 21 but if the patient has a score higher than 11, he is suffering from anxiety or depression | from inclusion(RO=M3) to R12(Month 15 =12 month post inclusion) | 
| Evaluate the cost-utility of the coaching program. | incremental cost-effectiveness ratio (QALYs) | from inclusion(RO=M3) to R12(Month15 =12 month post inclusion) | 
| Assess correlations between quality of life and patient empowerment | evolution over time of the patient's speech (semi-directive interviews) | from inclusion(RO=M3) to R12(Month15 =12 month post inclusion) | 
| Assess the overall survival of participants | measure the overall survival rate at M15/R12 | from inclusion(RO=M3) to R12(Month15 =12 month post inclusion) |