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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groupe OC (Onco-Coaching) | Experimental | 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. |
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| Groupe C (Contrôle) | Active Comparator | the patient will have standard management including also questionnaires and semi-structured interviews within the same time frame as the experimental arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interviews with coachs, semi-structured interviews and questionnaires | Other | 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) |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique GENRE, Dr | Contact | 0491223778 | drci.up@ipc.unicancer.fr | |
| Allison ARTHUR | Contact | 0491223448 |
| Name | Affiliation | Role |
|---|---|---|
| Didier BLAISE, Pr | Institut Paoli-Calmettes | Principal Investigator |
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They will be randomized unequally (2:1) into one of the study groups
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| semi-structured interviews and questionnaires | Other | 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) |
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| 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) |
| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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