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Spots Global Cancer Trial Database for Evaluation of the Ambulatory Medical Assistance Nurse Program in Chronic Lymphocytic Leukemia

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Trial Identification

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

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

Study ID: NCT05350826

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CH Sud Réunion, Saint Pierre, ILE DE LA Reunion, France

CHU d'Angers, Angers, , 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

CHRU de Nancy, Nancy, , France

Institut de Cancérologie du Gard, Nîmes, , France

Hôpital Saint-Louis, Paris, , France

CHU de Reims- Hôpital R.Debré, Reims, , France

CHU de RENNES, Rennes, , France

Hôpital Bretonneau, Tours, , France

CH Bretagne Atlantique Vannes, Vannes, , France

Contact Details

Name: Loïc YSEBAERT, MD, PhD

Affiliation: University Hospital, Toulouse

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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