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This is an open-label, single-centre, category 2 "Jardé Law" proof-of-concept study designed to demonstrate the feasibility of a decentralised care pathway for patients with cancer or haematological malignancies receiving oral treatment.
The study will be conducted on a population of 33 patients.
In current practice, patients with certain solid cancers or haematological malignancies may be prescribed oral chemotherapy on a retroceded basis. In these cases, the oncologist (coordinating investigator) sees the patient for a consultation every 3 cycles to prescribe/renew the treatment for approximately 3 months. Every month, the patient returns to the centre to have the treatment dispensed by the hospital pharmacy. No medical consultation is associated with this visit.
In this study, it is proposed to decentralise the delivery of treatment to these patients by introducing two visits to the patient's home by a service-providing nurse.
The decentralised patient pathway will be organised and monitored by the Advanced Practice Nurse (APN) at the investigating centre, who will be responsible in particular for coordination with the service-providing nurse and the hospital pharmacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with solid cancer or haematological malignancies and requiring oral chemotherapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decentralised Pathway Coordinated by the Advanced Practice Nurse | Other | For each patient enrolled in the study: a decentralised treatment delivery route will be organised. To achieve this, two visits will be planned by the investigating centre's Advanced Practice Nurse (APN) and carried out at the patient's home by a service-providing nurse. During these visits, the APN will take the patient's vital signs before handing over the treatment. In addition, for the purposes of the study, during the 2nd visit the patient will be asked to complete a satisfaction questionnaire. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint was defined as the feasibility of decentralisation. | Feasibility is a composite criterion, defined according to two dimensions: exhaustive collection of clinical data and logistical feasibility. For a patient, decentralisation will be considered feasible if success is observed for both dimensions. | 7 months for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Patient adherence to decentralised management. | This will be measured by the acceptance rate of trial participants compared with the number of proposals made. | 7 months for each patient |
| Patient satisfaction with decentralised management. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre BORIES | Contact | 05 31 15 65 14 | Bories.pierre@iuct-oncopole.fr | |
| Alexandra LAMBERT | Contact | 05 31 15 57 98 | lambert.alexandra@iuct-oncopole.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire du Cancer de Toulouse - Oncopole | Recruiting | Toulouse | 31059 | France |
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This will be evaluated according to different components using a likert scale. Patients will be asked 10 questions to assess their satisfaction. There will be 5 possible answers ranging from 'completely agree' to 'completely disagree'.
| 7 months for each patient |
| Time taken to collect data from home to site. | This will be defined as the time between the date of the home visit and the date on which the data is 'uploaded' into the investigating centre's computerised patient record. | 7 months for each patient |
| The rate of patients for whom the data interface well with the site's electronic patient record. | This is defined as the ratio of the number of patients for whom the data has been 'uploaded' into the electronic patient record to the total number of patients. | 7 months for each patient |
| The operation of the outsourced computerised patient file tool (MHCare). | This will be assessed at each visit by the rate of patients for whom the tool worked well. | 7 months for each patient |