Chronic Lymphoid Leukemia
Conditions
Keywords
Targeted therapy, Ambulatory medical assistance, Chronic lymphoid leukemia, Real-world costs
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.
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.
Interventions
OTHERAmbulatory 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.
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactLoïc YSEBAERT, MD, PhD
Backup ContactSandra DE BARROS
Outcome results
None listed