Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06713811

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

Led by Private Hospital of Confluent, France · Updated on 2025-06-13

110

Participants Needed

3

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Follow-up for hemopathy requiring oral therapy lasting more than 6 months (first line or more)
  • Intravenous treatments allowed alongside oral therapy as per guidelines
  • Patient must be affiliated with a social security scheme
  • Patient must provide written consent before study procedures
Not Eligible

You will not qualify if you...

  • Oral treatment expected to last less than 6 months
  • Brain tumor involvement
  • Other active cancer within 3 years, except certain skin, prostate, and cervical cancers treated only by surgery
  • Pregnancy or breastfeeding
  • Persons deprived of liberty or under legal guardianship
  • Dementia, mental illness, or psychiatric conditions affecting consent or compliance
  • Inability to participate due to psychological, social, family, or geographic reasons
  • No internet connection
  • No telephone line

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Clinique de l'Europe

Amiens, France, 80090

Actively Recruiting

2

Clinique de la Baie

Morlaix, France, 29672

Actively Recruiting

3

Hôpital Privé du Confluent

Nantes, France, 44000

Actively Recruiting

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Research Team

K

Katell Le Dû, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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