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

NCT06713811 | Recruiting

• 1 other identifier: 2024-23-HPC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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).

Conditions

Hemopathies

Keywords

observance; malignant hemopathies; telemonitoring

Outcome Measures

Primary Outcomes (1)

• Observance

  Observance will be evaluated by Girerd questionnaire (6 questions : 7 questions with 0 or 1). A score \>=3 indicates a poor adhesion, 1-2 is an average adhesion and \<6 a good adhesion.

  month 1, month 3, month 6

Secondary Outcomes (4)

• Adverse events

  month 1, month 3 and month 6 for control arm ; as they occur for experimental arm

• Number of unexpected hospitalizations

  6 months

• The duration of unexpected hospitalizations

  6 months

• Reason for unexpected hospitalizations

  6 months

Study Arms (2)

standard

NO INTERVENTION

experimental

EXPERIMENTAL

Other: Telemonitoring

Interventions

Telemonitoring OTHER

Cureety is a digital telemonitoring platform specially designed to monitor cancer patients through self-reporting of adverse events. It supports patients and medical teams to complement existing care practices.

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Private Hospital of Confluent, France: lead

Study Sites (3)

Clinique de l'Europe

Amiens, 80090, France

RECRUITING

Clinique de la Baie

Morlaix, 29672, France

RECRUITING

Hôpital Privé du Confluent

Nantes, 44000, France

RECRUITING

Central Study Contacts

Katell Le Dû, MD

CONTACT

+33 6 15 24 60 67; dr.ledu@groupeconfluent.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 3, 2024
• Study Start: May 22, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)