NCT06713811: EMMA

Evaluation of the Impact of Electronic Monitoring on Patient Compliance in Hematology

Recruiting now NA Last updated 13 June 2025

What this trial tests

NA trial testing Telemonitoring in Hemopathies in 110 participants. Currently enrolling.

Timeline

22 May 2025

Primary endpoint
1 May 2027

1 July 2027

Quick facts

Lead sponsor	Private Hospital of Confluent, France
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	22 May 2025
Primary completion	1 May 2027
Estimated completion	1 July 2027
Sites	3 locations across France

Drugs / interventions tested

• Telemonitoring

Conditions studied

• Hemopathies — all drugs for Hemopathies →

Sponsor

Private Hospital of Confluent, France

Who can join

18 and older, any sex, with Hemopathies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Management of hemopathies has progressed with the arrival of new drugs such as CAR T-cells (Chimeric Antigen Receptor T-cells), immunotherapy and targeted therapies, while increasing emphasis is being placed on outpatient care.

The emergence of oral therapies has simplified the treatment pathway, but they are not without their undesirable effects, which can sometimes lead to treatment suspension or even discontinuation. These undesirable effects may be related either to the haemopathy (pain, general signs, fatigue, malnutrition, infection, etc.), or to the toxicity of the treatments, or to co-morbidities. It is therefore essential to detect and manage these adverse effects in real time.

In patients treated with oral therapy, poor compliance (\<80% of doses taken) can have a direct impact on progression-free survival and sometimes on overall survival (Dashputre et al, Williams et al).

It is therefore imperative for patients to follow prescribed treatments correctly, and for doctors to check for the absence of side-effects that could adversely affect patient safety and quality of life.

Monitoring of these side effects varies from one center to another: it can be "classic", with a call from the patient or GP in the event of an event; it can be telephone-based (AMA-type coordination nurse for Ambulatory Medical Assistance); and finally, it can be electronic via a remote monitoring application.

Monitoring by electronic application has been evaluated in oncology, with a benefit on early detection of side effects or signs of disease progression The human resources and organization of hematology departments are highly heterogeneous, and few studies have been carried out for patients treated long-term (≥ 6 months) with oral therapy.

For these patients, therapeutic compliance is one of the parameters to be assessed, in order to optimize dose-intensity and duration of response.

We propose here to compare two types of follow-up for patients due to start oral therapy: standard follow-up and follow-up by electronic application (Cureety).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.