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The emergence of targeted therapy (ibrutinib, venetoclax, acalabrutinib) has revolutionized the management practices of chronic lymphoid leukemia due to their effectiveness. However, targeted therapy induces a significant additional cost compared to treatment with immunochemotherapy and their use can be problematic due to the frequent occurrence of side effects, which can be serious. In order to improve the current management of patients treated with targeted therapy, the aim of this study is to evaluate the ambulatory medical assistance nurse program. Ambulatory medical assistance is based on regular telephone calls to patient's homes by a specialist nurse and consists of the monitoring, detection and early management of possible adverse effects of targeted therapy, in link with the hematologist. The main objective of this clinical research is to determine efficiency of the ambulatory medical assistance nurse program.
This research is a prospective randomized multicenter comparative study in 2 parallel groups (1: 1) : patients benefiting from the ambulatory medical assistance nurse program in addition to conventional care versus patients benefiting from conventional care. For each patient, data will be collected during 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory medical assistance | Experimental | Patient benefiting from the ambulatory medical assistance nurse program in addition to conventional care for patients chronic lymphoid leukemia under targeted therapy |
|
| Conventional care | No Intervention | Patient benefiting from conventional care for patients chronic lymphoid leukemia under targeted therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory medical assistance | Other | Ambulatory medical assistance is a patient-empowerment program and consists to programmed phone calls (bi-monthly for the first 6 months then monthly for the following 6 months) delivered by an oncology nurse, in link with the hematologist. |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory medical assistance efficiency | To evaluate at 1 year the efficiency of the ambulatory medical assistance program, through the scale EQ-5D-5L | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of patients | Compare the survival of patients with or without ambulatory medical assistance at 1 and 2 years | 1 and 2 years after initiation of targeted therapy |
| Quality of life of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loïc YSEBAERT, MD, PhD | Contact | 0531156351 | 33 | ysebaert.loic@iuct-oncopole.fr |
| Sandra DE BARROS | Contact | 0561145982 | 33 | debarros.s@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Loïc YSEBAERT, MD, PhD | University Hospital, Toulouse | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Sud Réunion | Recruiting | Saint-Pierre | ILE de LA Reunion | France |
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Compare the quality of life of patients with or without ambulatory medical assistance with European Organisation for Research and Treatment of Cancer C30 scores
| at inclusion, 1 and 2 years after initiation of targeted therapy |
| Cost-effectiveness analysis | Perform a cost-effectiveness analysis at 1 and 2 years comparing costs and survival from a community perspective | at 1 and 2 years |
| CHU d'Angers | Recruiting | Angers | France |
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| CHU DE BREST Hôpital A.Morvan | Recruiting | Brest | France |
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| Hôpital Estaing | Recruiting | Clermont-Ferrand | France |
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| CHRU Dijon | Recruiting | Dijon | France |
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| CH du Mans | Recruiting | Le Mans | France |
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| Centre Hospitalier Lyon sud | Recruiting | Lyon | France |
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| Centre Léon Bérard | Recruiting | Lyon | France |
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| Hôpital Emile MULLER | Recruiting | Mulhouse | France |
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| CHRU de Nancy | Recruiting | Nancy | France |
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| Institut de Cancérologie du Gard | Recruiting | Nîmes | France |
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| Hôpital Saint-Louis | Recruiting | Paris | 75008 | France |
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| CHU de Reims- Hôpital R.Debré | Recruiting | Reims | France |
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| CHU de RENNES | Recruiting | Rennes | France |
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| Hôpital Bretonneau | Recruiting | Tours | France |
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| CH Bretagne Atlantique Vannes | Recruiting | Vannes | France |
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| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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