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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
450
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.
CH Sud Réunion
Saint-Pierre, ILE de LA Reunion, France
RECRUITINGCHU d'Angers
Angers, France
RECRUITINGCHU DE BREST Hôpital A.Morvan
Brest, France
RECRUITINGHôpital Estaing
Clermont-Ferrand, France
RECRUITINGCHRU Dijon
Dijon, France
RECRUITINGCH du Mans
Le Mans, France
RECRUITINGCentre Hospitalier Lyon sud
Lyon, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGHôpital Emile MULLER
Mulhouse, France
RECRUITINGCHRU de Nancy
Nancy, France
RECRUITING...and 6 more locations
Ambulatory medical assistance efficiency
To evaluate at 1 year the efficiency of the ambulatory medical assistance program, through the scale EQ-5D-5L
Time frame: 1 year
Survival of patients
Compare the survival of patients with or without ambulatory medical assistance at 1 and 2 years
Time frame: 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
Time frame: 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
Time frame: at 1 and 2 years
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