Evaluation of the Ambulatory Medical Assistance Nurse Program in Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study

Conditions
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Chronic Lymphoid Leukemia

Intervention / Treatment
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* Other: Ambulatory medical assistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over the age of 18 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. Be able to understand the objective and the constraints related to the research Patient having signed the consent form Patient with Social Security affiliation or equivalent Person able to speak on the phone Exclusion Criteria: Patient who has already benefited from ambulatory medical assistance nurse program with a previous treatment Pregnant women Patients under judicial protection

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory medical assistance<br>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<br>* 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.<br>|
| No Intervention: Conventional care<br>Patient benefiting from conventional care for patients chronic lymphoid leukemia under targeted therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Targeted therapy, Ambulatory medical assistance, Chronic lymphoid leukemia, Real-world costs