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)

Обзор

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.

Вмешательства

• Другое 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 questionn

Первичные конечные точки

• The primary endpoint was defined as the feasibility of decentralisation. [Срок оценки: 7 months for each patient]

Вторичные конечные точки (5)

• Patient adherence to decentralised management. [Срок оценки: 7 months for each patient]
• Patient satisfaction with decentralised management. [Срок оценки: 7 months for each patient]
• Time taken to collect data from home to site. [Срок оценки: 7 months for each patient]
• The rate of patients for whom the data interface well with the site's electronic patient record. [Срок оценки: 7 months for each patient]
• The operation of the outsourced computerised patient file tool (MHCare). [Срок оценки: 7 months for each patient]

Критерии участия

Критерии включения

• 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.
• Patient willing to make two home visits within 6 months of inclusion.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse

Идентификаторы

NCT: NCT06797037 · 24GENE18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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