NCT05350826

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphoid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-13
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-04-28
• Last updated: 2023-09-21

Locations

16 sites across 1 country: France