Haematological Malignancies, Solid Cancer
Conditions
Keywords
Retroceded oral chemotherapy
Brief summary
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.
Interventions
OTHERDecentralised Pathway Coordinated by the Advanced Practice Nurse
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.
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient over 18. 2. A patient with solid cancer or haematological malignancy receiving oral retroceded therapy as part of standard management. 3. Patient with a performance index (ECOG): 0-2. 4. Patient contactable by telephone for follow-up by the Advanced Practice Nurse. 5. Patient willing to make two home visits within 6 months of inclusion.
Exclusion criteria
1. Pregnant or breast-feeding patient. 2. Any psychological, family, geographical or social condition which, in the judgement of the oncologist, could potentially prevent the collection of informed consent or hinder compliance with the study protocol. 3. Patients deprived of their liberty by administrative or legal decision, or patients under guardianship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint was defined as the feasibility of decentralisation. | 7 months for each patient | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient adherence to decentralised management. | 7 months for each patient | This will be measured by the acceptance rate of trial participants compared with the number of proposals made. |
| Patient satisfaction with decentralised management. | 7 months for each patient | 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'. |
| Time taken to collect data from home to site. | 7 months for each patient | 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. |
| The rate of patients for whom the data interface well with the site's electronic patient record. | 7 months for each patient | 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. |
| The operation of the outsourced computerised patient file tool (MHCare). | 7 months for each patient | This will be assessed at each visit by the rate of patients for whom the tool worked well. |
Countries
France
Contacts
CONTACTPierre BORIES
CONTACTAlexandra LAMBERT
Outcome results
None listed