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)

NCT06797037 | Recruiting

• 1 other identifier: 24GENE18
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

Retroceded oral chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Patient adherence to decentralised management.

  7 months for each patient

• Patient satisfaction with decentralised management.

  7 months for each patient

• Time taken to collect data from home to site.

  7 months for each patient

• The rate of patients for whom the data interface well with the site's electronic patient record.

  7 months for each patient

• The operation of the outsourced computerised patient file tool (MHCare).

  7 months for each patient

Study Arms (1)

Patients with solid cancer or haematological malignancies and requiring oral chemotherapy

OTHER

Other: Decentralised Pathway Coordinated by the Advanced Practice Nurse

Interventions

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.

Patients with solid cancer or haematological malignancies and requiring oral chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18.
• A patient with solid cancer or haematological malignancy receiving oral retroceded therapy as part of standard management.
• Patient with a performance index (ECOG): 0-2.
• Patient contactable by telephone for follow-up by the Advanced Practice Nurse.

You may not qualify if:

• Pregnant or breast-feeding patient.
• 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.
• Patients deprived of their liberty by administrative or legal decision, or patients under guardianship.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

RECRUITING

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 19, 2027
• Study Completion (Estimated): May 19, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

FR (1)