THEMIS: Evaluation of the Ambulatory Medical Assistance Nurse Program in Chronic Lymphocytic Leukemia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ambulatory medical assistance Patient benefiting from the ambulatory medical assistance nurse program in addition to conventional care for patients chronic lymphoid leukemia under targeted therapy |
Other: Ambulatory medical assistance
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.
|
| No Intervention: Conventional care Patient benefiting from conventional care for patients chronic lymphoid leukemia under targeted therapy |
Outcome Measures
Primary Outcome Measures
- Ambulatory medical assistance efficiency [1 year]
To evaluate at 1 year the efficiency of the ambulatory medical assistance program, through the scale EQ-5D-5L
Secondary Outcome Measures
- Survival of patients [1 and 2 years after initiation of targeted therapy]
Compare the survival of patients with or without ambulatory medical assistance at 1 and 2 years
- Quality of life of patients [at inclusion, 1 and 2 years after initiation of targeted therapy]
Compare the quality of life of patients with or without ambulatory medical assistance with European Organisation for Research and Treatment of Cancer C30 scores
- Cost-effectiveness analysis [at 1 and 2 years]
Perform a cost-effectiveness analysis at 1 and 2 years comparing costs and survival from a community perspective
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women over the age of 18
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Patients with chronic lymphoid leukemia and starting treatment with targeted therapy: ibrutinib, venetoclax or acalabrutinib, alone or in combination with obinutuzumab or rituximab in 1L or R/R according to the indications of the Marketing Authorization.
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Be able to understand the objective and the constraints related to the research
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Patient having signed the consent form
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Patient with Social Security affiliation or equivalent
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Person able to speak on the phone
Exclusion Criteria:
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Patient who has already benefited from ambulatory medical assistance nurse program with a previous treatment
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Pregnant women
-
Patients under judicial protection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH Sud Réunion | Saint Pierre | ILE DE LA Reunion | France | |
| 2 | CHU d'Angers | Angers | France | ||
| 3 | CHU DE BREST Hôpital A.Morvan | Brest | France | ||
| 4 | Hôpital Estaing | Clermont-Ferrand | France | ||
| 5 | CHRU Dijon | Dijon | France | ||
| 6 | CH du Mans | Le Mans | France | ||
| 7 | Centre Hospitalier Lyon sud | Lyon | France | ||
| 8 | Centre Léon Bérard | Lyon | France | ||
| 9 | Hôpital Emile MULLER | Mulhouse | France | ||
| 10 | CHRU de Nancy | Nancy | France | ||
| 11 | Institut de Cancérologie du Gard | Nîmes | France | ||
| 12 | Hôpital Saint-Louis | Paris | France | 75008 | |
| 13 | CHU de Reims- Hôpital R.Debré | Reims | France | ||
| 14 | CHU de RENNES | Rennes | France | ||
| 15 | Hôpital Bretonneau | Tours | France | ||
| 16 | CH Bretagne Atlantique Vannes | Vannes | France |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Study Director: Loïc YSEBAERT, MD, PhD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/21/0340