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

Not Applicable

Recruiting

• Conditions: Hemopathies

• Registration Number: NCT06713811
• Lead Sponsor: Private Hospital of Confluent, France

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-03
• Status Verified: 2025-05
• Study Start: 2025-05-22
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-28
• Primary Completion: 2027-05-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Follow-up for haemopathy justifying initiation of oral therapy (one or more authorized molecules) for more than 6 months (1st line of treatment or more),
• Intravenous treatment may be associated with it, in accordance with international recommendations (immunotherapy, corticosteroid therapy, other),
• Patient affiliated to a social security scheme,
• Patient having given written consent prior to any specific study procedure.

Exclusion Criteria

• Oral treatment expected to last < 6 months,
• Cerebral tumor involvement,
• Other active cancer < 3 years, excluding skin, prostate and cervical carcinomas treated by surgery alone,
• Pregnancy or breast-feeding
• Persons deprived of their liberty, under guardianship or curatorship,
• Dementia, mental alteration or psychiatric pathology that could compromise the patient's informed consent and/or compliance with the protocol and trial follow-up,
• Patient unable to undergo protocol monitoring for psychological, social, family or geographical reasons.
• No Internet connection
• No telephone line

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Observance	month 1, month 3, month 6	Observance will be evaluated by Morisky questionnaire (8 questions : 7 questions with 0 or 1 and 1 question with Likert scale from 0 to 1). A score \>=8 indicates a good adhesion, 6-8 is an average adhesion and \<6 a poor adhesion.

Secondary Outcome Measures

Name	Time	Method
Adverse events	month 1, month 3 and month 6 for control arm ; as they occur for experimental arm	Adverse events will be reported according to international terminology (CTCAE, Common Terminology Criteria for Adverse Events v5.0), and recorded at each visit for patients in the control arm and by .
Number of unexpected hospitalizations	6 months	The number of unexpected hospitalizations will be recorded per arm for the duration of the study
The duration of unexpected hospitalizations	6 months	The duration of unexpected hospitalizations will be recorded per arm for the duration of the study
Reason for unexpected hospitalizations	6 months	The reason for unexpected hospitalizations will be recorded per arm for the duration of the study

Trial Locations

Locations (3)

Clinique de l'Europe; 🇫🇷 Amiens, France

Clinique de la Baie; 🇫🇷 Morlaix, France

Hôpital Privé du Confluent; 🇫🇷 Nantes, France