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)

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Cancer; Haematological Malignancies
• Intervention / Treatment: Other: Decentralised Pathway Coordinated by the Advanced Practice Nurse

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre BORIES; Phone Number: 05 31 15 65 14; Email: Bories.pierre@iuct-oncopole.fr
• Study Contact Backup: Name: Alexandra LAMBERT; Phone Number: 05 31 15 57 98; Email: lambert.alexandra@iuct-oncopole.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Institut Universitaire du Cancer de Toulouse - Oncopole
    • Principal Investigator: Pierre Bories, MD
    • Contact: Pierre BORIES, MD; Phone Number: 05 31 15 65 14; Email: Bories.pierre@iuct-oncopole.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients with solid cancer or haematological malignancies and requiring oral chemotherapy

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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
Patient satisfaction with decentralised management.	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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): May 19, 2027
• Study Completion (Estimated): May 19, 2027

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Retroceded oral chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 24GENE18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No