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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02515-48 | Other Identifier | 2017-A02515-48 |
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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
| Association des foulées de la Haute Lozère | UNKNOWN |
| Association CEMSBM | UNKNOWN |
| Connaître et Combattre les Myélodysplasies |
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Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional haematological care | Experimental | Patients with haematological malignancy Conventional haematological care |
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| Conventional care associated with a monthly consultation | Experimental | Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early palliative care integration | Drug | The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life evaluation: standardized questionnaire | Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being [score range 0-28], Social/Family Well-Being [score range 0-28], Emotional Well-Being [score range 0-24], and Functional Well-Being [score range 0-28] and specific questions concerning anemia [score range 0-80]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score [score range 0-188]. | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of discomfort symptoms | evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS) | at Day 0, 3 months, 6 months, 9 months, 12 months |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | 0473754963 | drci@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Métropole Savoie | Not yet recruiting | Chambéry | 73000 | France |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| UNKNOWN |
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no masking
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| at day 1 : from the randomization until the date of death or until 1 year [study end]. |
| Satisfaction of the care pathwaydesired by the patient | matching between patients desires writing in the medical file and the providing care | at 12 months or death |
| cost-effectiveness analysis | The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices). | at 12 months or death |
| Chu Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| Chu Limoges | Recruiting | Limoges | 87042 | France |
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| Centre Léon Bérard | Not yet recruiting | Lyon | 69008 | France |
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| Institut de Cancérologie de la Loire | Recruiting | Saint-Priest-en-Jarez | 42271 | France |
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| CH Jacques Lacarin | Not yet recruiting | Vichy | 03200 | France |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |