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

September 18, 2023 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU d'Angers
        • Contact:
          • Aline CLAVERT, MD
      • Brest, France
        • Recruiting
        • CHU DE BREST Hôpital A.Morvan
        • Contact:
          • Hussam SAAD, MD
      • Clermont-Ferrand, France
        • Recruiting
        • Hôpital Estaing
        • Contact:
          • Romain GUIZEZ, PhD
      • Dijon, France
        • Recruiting
        • CHRU DIjon
        • Contact:
          • Cédric ROSSI, MD
      • Le Mans, France
        • Recruiting
        • CH du Mans
        • Contact:
          • Kamel Laribi, MD
      • Lyon, France
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
          • Emmanuelle FERRANT, MD
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Anne-Sophie MICHALLET, MD
      • Mulhouse, France
        • Recruiting
        • Hôpital Emile Muller
        • Contact:
          • Bernard Drenou, MD
      • Nancy, France
        • Recruiting
        • CHRU de Nancy
        • Contact:
          • Pierre FEUGIER, PhD
      • Nîmes, France
        • Recruiting
        • Institut de Cancérologie du Gard
        • Contact:
          • Eric JOURDAN, MD
      • Paris, France, 75008
        • Recruiting
        • Hopital Saint-Louis
        • Contact:
          • Catherine Thieblemont, MD
      • Reims, France
        • Recruiting
        • CHU de Reims- Hôpital R.Debré
        • Contact:
          • Anne QUINQUENEL, MD
      • Rennes, France
        • Recruiting
        • CHU de Rennes
        • Contact:
          • Sophie DE GUIBERT, MD
      • Tours, France
        • Recruiting
        • Hôpital Bretonneau
        • Contact:
          • Caroline DARTIGEAS, MD
      • Vannes, France
        • Recruiting
        • CH Bretagne Atlantique vannes
        • Contact:
          • Mélanie MERCIER, MD
    • ILE DE LA Reunion
      • Saint Pierre, ILE DE LA Reunion, France
        • Recruiting
        • CH Sud Réunion
        • Contact:
          • Hugo LEGENDRE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 and 2 years after initiation of targeted therapy
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
at inclusion, 1 and 2 years after initiation of targeted therapy
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
at 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Study Director: Loïc YSEBAERT, MD, PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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