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Trial record 3 of 16 for:    themis
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Evaluation of the Ambulatory Medical Assistance Nurse Program in Chronic Lymphocytic Leukemia (THEMIS)

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ClinicalTrials.gov Identifier: NCT05350826
Recruitment Status : Recruiting
First Posted : April 28, 2022
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Lymphoid Leukemia Other: Ambulatory medical assistance Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Targeted Therapies in Chronic Lymphocytic Leukemia and Medico-economic Evaluation of the Ambulatory Medical Assistance Nurse Program : a Prospective Multicenter Randomized Study
Actual Study Start Date : April 13, 2023
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 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.
No Intervention: Conventional care
Patient benefiting from conventional care for patients chronic lymphoid leukemia under targeted therapy


Outcome Measures
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Primary Outcome Measures :
  1. Ambulatory medical assistance efficiency [ Time Frame: 1 year ]
    To evaluate at 1 year the efficiency of the ambulatory medical assistance program, through the scale EQ-5D-5L


Secondary Outcome Measures :
  1. Survival of patients [ Time Frame: 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

  2. Quality of life of patients [ Time Frame: 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

  3. Cost-effectiveness analysis [ Time Frame: at 1 and 2 years ]
    Perform a cost-effectiveness analysis at 1 and 2 years comparing costs and survival from a community perspective


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05350826


Contacts
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Contact: Loïc YSEBAERT, MD, PhD 0531156351 ext 33 ysebaert.loic@iuct-oncopole.fr
Contact: Sandra DE BARROS 0561145982 ext 33 debarros.s@chu-toulouse.fr

Locations
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France
CH Sud Réunion Recruiting
Saint Pierre, ILE DE LA Reunion, France
Contact: Hugo LEGENDRE, MD         
CHU d'Angers Recruiting
Angers, France
Contact: Aline CLAVERT, MD         
CHU DE BREST Hôpital A.Morvan Recruiting
Brest, France
Contact: Hussam SAAD, MD         
Hôpital Estaing Recruiting
Clermont-Ferrand, France
Contact: Romain GUIZEZ, PhD         
CHRU Dijon Recruiting
Dijon, France
Contact: Cédric ROSSI, MD         
CH du Mans Recruiting
Le Mans, France
Contact: Kamel LARIBI, MD         
Centre Hospitalier Lyon sud Recruiting
Lyon, France
Contact: Emmanuelle FERRANT, MD         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Anne-Sophie MICHALLET, MD         
Hôpital Emile MULLER Recruiting
Mulhouse, France
Contact: Bernard DRENOU, MD         
CHRU de Nancy Recruiting
Nancy, France
Contact: Pierre FEUGIER, PhD         
Institut de Cancérologie du Gard Recruiting
Nîmes, France
Contact: Eric JOURDAN, MD         
Hôpital Saint-Louis Recruiting
Paris, France, 75008
Contact: Catherine THIEBLEMONT, MD         
CHU de Reims- Hôpital R.Debré Recruiting
Reims, France
Contact: Anne QUINQUENEL, MD         
CHU de RENNES Recruiting
Rennes, France
Contact: Sophie DE GUIBERT, MD         
Hôpital Bretonneau Recruiting
Tours, France
Contact: Caroline DARTIGEAS, MD         
CH Bretagne Atlantique Vannes Recruiting
Vannes, France
Contact: Mélanie MERCIER, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Study Director: Loïc YSEBAERT, MD, PhD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT05350826    
Other Study ID Numbers: RC31/21/0340
First Posted: April 28, 2022    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Targeted therapy
Ambulatory medical assistance
Chronic lymphoid leukemia
Real-world costs
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes