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

Not Applicable

Recruiting

• Conditions: Chronic Lymphoid Leukemia
• Interventions: Other: Ambulatory medical assistance

• Registration Number: NCT05350826
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-28
• Study Start: 2023-04-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambulatory medical assistance	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (16)

CHU d'Angers; 🇫🇷 Angers, France

CH Sud Réunion; 🇫🇷 Saint Pierre, ILE DE LA Reunion, France

CHU DE BREST Hôpital A.Morvan; 🇫🇷 Brest, France

Hôpital Estaing; 🇫🇷 Clermont-Ferrand, France

CHRU Dijon; 🇫🇷 Dijon, France

CH du Mans; 🇫🇷 Le Mans, France

Centre Hospitalier Lyon sud; 🇫🇷 Lyon, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hôpital Emile MULLER; 🇫🇷 Mulhouse, France

CHU de Reims- Hôpital R.Debré; 🇫🇷 Reims, France

Institut de Cancérologie du Gard; 🇫🇷 Nîmes, France

CHRU de Nancy; 🇫🇷 Nancy, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

CHU de RENNES; 🇫🇷 Rennes, France

Hôpital Bretonneau; 🇫🇷 Tours, France

CH Bretagne Atlantique Vannes; 🇫🇷 Vannes, France