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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)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later May 19, 2027 → Nov 19, 2028
See other at-risk trials from Institut Claudius Regaud

Record History

  1. Notable Primary and study completion pushed from May 19, 2027 to Nov 19, 2028v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Feb 2027 to May 19, 2027
    • Start date changed from estimate of Apr 2025 to May 19, 2025
    • Site details revised
    v4
  4. Notable Start date: Feb 2025 to Apr 2025v3
  5. Minor Secondary endpoints: details revised at 1 of 5 entriesv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06797037
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)
Solid Cancer, Haematological Malignancies
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov