Solid CancerNCT06797037
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)
A study testing Decentralised Pathway Coordinated by the Advanced Practice Nurse in people with Solid Cancer and Haematological Malignancies, run by Institut Claudius Regaud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer, Haematological Malignancies
- What is being tested?
- Decentralised Pathway Coordinated by the Advanced Practice Nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2025to 19 Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059
Pierre BORIES, MD, 05 31 15 65 14, Bories.pierre@iuct-oncopole.fr
Pierre BORIES, MD
About this study
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.
Read more
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
- Being tested
- Decentralised Pathway Coordinated by the Advanced Practice Nurse
- Keywords
- Retroceded oral chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decentralised Pathway Coordinated by the Advanced Practice NurseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with solid cancer or haematological malignancies and requiring oral chemotherapy | Other | Not described Receives: Other: Decentralised Pathway Coordinated by the Advanced Practice Nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months for each patient
Secondary outcomes (5)
Patient adherence to decentralised management.
This will be measured by the acceptance rate of trial participants compared with the number of proposals made.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start19 May 2025
- Primary completion19 Nov 2028 (estimated)
- Study completion19 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797037
- Sponsor's protocol ID
- 24GENE18
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No