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

ConditionHemopathies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrivate Hospital of Confluent, France

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telemonitoring

    Other intervention

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: standardNo intervention 0 interventions
Group B: experimentalExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
month 1, month 3, month 6

Secondary outcomes

1

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 .

Time frame
month 1, month 3 and month 6 for control arm ; as they occur for experimental arm
2

Number of unexpected hospitalizations

The number of unexpected hospitalizations will be recorded per arm for the duration of the study

Time frame
6 months
3

The duration of unexpected hospitalizations

The duration of unexpected hospitalizations will be recorded per arm for the duration of the study

Time frame
6 months
4

Reason for unexpected hospitalizations

The reason for unexpected hospitalizations will be recorded per arm for the duration of the study

Time frame
6 months

Other outcomes

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