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)

NCT ID: NCT06797037

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2027-05-19

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.

Conditions

Solid Cancer; Haematological Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with solid cancer or haematological malignancies and requiring oral chemotherapy

Group Type: OTHER

Decentralised Pathway Coordinated by the Advanced Practice Nurse

Intervention Type: 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.

Interventions

Decentralised 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pierre BORIES

Role: CONTACT

Bories.pierre@iuct-oncopole.fr

05 31 15 65 14

Alexandra LAMBERT

Role: CONTACT

lambert.alexandra@iuct-oncopole.fr

05 31 15 57 98

Facility Contacts

Pierre BORIES, MD

Role: primary

Bories.pierre@iuct-oncopole.fr

05 31 15 65 14

Other Identifiers

24GENE18

Identifier Type: -

Identifier Source: org_study_id