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

Primary Purpose

Chronic Lymphoid Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ambulatory medical assistance
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Lymphoid Leukemia focused on measuring Targeted therapy, Ambulatory medical assistance, Chronic lymphoid leukemia, Real-world costs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Sud RéunionRecruiting
  • CHU d'AngersRecruiting
  • CHU DE BREST Hôpital A.MorvanRecruiting
  • Hôpital EstaingRecruiting
  • CHRU DijonRecruiting
  • CH du MansRecruiting
  • Centre Hospitalier Lyon sudRecruiting
  • Centre Léon BérardRecruiting
  • Hôpital Emile MULLERRecruiting
  • CHRU de NancyRecruiting
  • Institut de Cancérologie du GardRecruiting
  • Hôpital Saint-LouisRecruiting
  • CHU de Reims- Hôpital R.DebréRecruiting
  • CHU de RENNESRecruiting
  • Hôpital BretonneauRecruiting
  • CH Bretagne Atlantique VannesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ambulatory medical assistance

Conventional care

Arm Description

Patient benefiting from the ambulatory medical assistance nurse program in addition to conventional care for patients chronic lymphoid leukemia under targeted therapy

Patient benefiting from conventional care for patients chronic lymphoid leukemia under targeted therapy

Outcomes

Primary Outcome Measures

Ambulatory medical assistance efficiency
To evaluate at 1 year the efficiency of the ambulatory medical assistance program, through the scale EQ-5D-5L

Secondary Outcome Measures

Survival of patients
Compare the survival of patients with or without ambulatory medical assistance at 1 and 2 years
Quality of life of patients
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
Perform a cost-effectiveness analysis at 1 and 2 years comparing costs and survival from a community perspective

Full Information

First Posted
April 7, 2022
Last Updated
September 18, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05350826
Brief Title
Evaluation of the Ambulatory Medical Assistance Nurse Program in Chronic Lymphocytic Leukemia
Acronym
THEMIS
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 Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphoid Leukemia
Keywords
Targeted therapy, Ambulatory medical assistance, Chronic lymphoid leukemia, Real-world costs

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ambulatory medical assistance
Arm Type
Experimental
Arm Description
Patient benefiting from the ambulatory medical assistance nurse program in addition to conventional care for patients chronic lymphoid leukemia under targeted therapy
Arm Title
Conventional care
Arm Type
No Intervention
Arm Description
Patient benefiting from conventional care for patients chronic lymphoid leukemia under targeted therapy
Intervention Type
Other
Intervention Name(s)
Ambulatory medical assistance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ambulatory medical assistance efficiency
Description
To evaluate at 1 year the efficiency of the ambulatory medical assistance program, through the scale EQ-5D-5L
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Survival of patients
Description
Compare the survival of patients with or without ambulatory medical assistance at 1 and 2 years
Time Frame
1 and 2 years after initiation of targeted therapy
Title
Quality of life of patients
Description
Compare the quality of life of patients with or without ambulatory medical assistance with European Organisation for Research and Treatment of Cancer C30 scores
Time Frame
at inclusion, 1 and 2 years after initiation of targeted therapy
Title
Cost-effectiveness analysis
Description
Perform a cost-effectiveness analysis at 1 and 2 years comparing costs and survival from a community perspective
Time Frame
at 1 and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loïc YSEBAERT, MD, PhD
Phone
0531156351
Ext
33
Email
ysebaert.loic@iuct-oncopole.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra DE BARROS
Phone
0561145982
Ext
33
Email
debarros.s@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc YSEBAERT, MD, PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Study Director
Facility Information:
Facility Name
CH Sud Réunion
City
Saint Pierre
State/Province
ILE DE LA Reunion
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo LEGENDRE, MD
Facility Name
CHU d'Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline CLAVERT, MD
Facility Name
CHU DE BREST Hôpital A.Morvan
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hussam SAAD, MD
Facility Name
Hôpital Estaing
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain GUIZEZ, PhD
Facility Name
CHRU Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric ROSSI, MD
Facility Name
CH du Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamel LARIBI, MD
Facility Name
Centre Hospitalier Lyon sud
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle FERRANT, MD
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie MICHALLET, MD
Facility Name
Hôpital Emile MULLER
City
Mulhouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard DRENOU, MD
Facility Name
CHRU de Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre FEUGIER, PhD
Facility Name
Institut de Cancérologie du Gard
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric JOURDAN, MD
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine THIEBLEMONT, MD
Facility Name
CHU de Reims- Hôpital R.Debré
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne QUINQUENEL, MD
Facility Name
CHU de RENNES
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie DE GUIBERT, MD
Facility Name
Hôpital Bretonneau
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline DARTIGEAS, MD
Facility Name
CH Bretagne Atlantique Vannes
City
Vannes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie MERCIER, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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