Clinical trial NCT06797037: Proof of Concept to Assess the Feasibility of a Decentralised Pathway Coordinated by the Advanced Practice Nurse for Patients Receiving Oral Treatment for Cancer or Malignant Haemopathy (ACCELER PLATFORM)
Official title: Proof of Concept to Assess the Feasibility of a Decentralised Pathway Coordinated by the Advanced Practice Nurse for Patients Receiving Oral Treatment for Cancer or Malignant Haemopathy (ACCELER PLATFORM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Cancer
Haematological Malignancies
Keywords: Retroceded oral chemotherapy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint was defined as the feasibility of decentralisation.
timeFrame: 7 months for each patient
Secondary outcomes:
measure: Patient adherence to decentralised management.
timeFrame: 7 months for each patient
measure: Patient satisfaction with decentralised management.
timeFrame: 7 months for each patient
measure: Time taken to collect data from home to site.
timeFrame: 7 months for each patient
measure: The rate of patients for whom the data interface well with the site's electronic patient record.
timeFrame: 7 months for each patient
measure: The operation of the outsourced computerised patient file tool (MHCare).
timeFrame: 7 months for each patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
Study officials:
References: