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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard | No Intervention | ||
| experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 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 . | month 1, month 3 and month 6 for control arm ; as they occur for experimental arm |
| Number of unexpected hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katell Le Dû, MD | Contact | +33 6 15 24 60 67 | dr.ledu@groupeconfluent.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Europe | Recruiting | Amiens | 80090 | France |
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The number of unexpected hospitalizations will be recorded per arm for the duration of the study |
| 6 months |
| The duration of unexpected hospitalizations | The duration of unexpected hospitalizations will be recorded per arm for the duration of the study | 6 months |
| Reason for unexpected hospitalizations | The reason for unexpected hospitalizations will be recorded per arm for the duration of the study | 6 months |
| Clinique de la Baie | Recruiting | Morlaix | 29672 | France |
|
| Hôpital Privé du Confluent | Recruiting | Nantes | 44000 | France |
|