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NCT Number: 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)

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.

Recruiting

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Key information

Conditions

Solid Cancer Haematological Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location status: Recruiting

Location contact

Pierre BORIES, MD

CONTACT

[email protected]

05 31 15 65 14

Pierre BORIES, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. The primary endpoint was defined as the feasibility of decentralisation.

    Time frame: 7 months for each patient

    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.

Secondary outcomes

  1. Patient adherence to decentralised management.

    Time frame: 7 months for each patient

    This will be measured by the acceptance rate of trial participants compared with the number of proposals made.

  2. Patient satisfaction with decentralised management.

    Time frame: 7 months for each patient

    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'.

  3. Time taken to collect data from home to site.

    Time frame: 7 months for each patient

    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.

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

    Time frame: 7 months for each patient

    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.

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

    Time frame: 7 months for each patient

    This will be assessed at each visit by the rate of patients for whom the tool worked well.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra LAMBERT

CONTACT

[email protected]

05 31 15 57 98

Pierre BORIES

CONTACT

[email protected]

05 31 15 65 14

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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