Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer
NCT ID: NCT02956876
Last Updated: 2020-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
754 participants
INTERVENTIONAL
2016-12-05
2020-12-31
Brief Summary
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Medical advances and societal leading to increased life expectancy, have operated a mutation of the cancer disease. Formerly fatal disease, it is now a chronic disease in some cases. These changes are causing new challenges for the health system.
To address this problem, it is asked health professionals to adapt the organization of health care delivery to improve efficiency, in a constrained economic environment. To this end, action 4.1 of the cancer plan includes the creation of clinical nursing profession, a proposal reiterated in article 120 of the French Health System Law. Nursing clinicians will be empowered to ensure, under certain conditions, prescription treatments protocolized of follow-up tests, further treatment and support, as well as the extension or adaptation of specific treatments.
This project is a first step, in France, in thinking around new organizations in the supply of care in oncology.
For patients, strengthening their monitoring during chemotherapy, will better know their tolerance regarding chemotherapy. This optimized management of chemotherapy-induced effects will help reduce the use of emergency care.
The establishment of such a practitioner will free medical time to handle the most complex patients and perform tasks related to research.
For hospital pharmacies this type of organization will optimize their productivity by anticipating orders for chemotherapy pockets.
This project represents an opportunity to demonstrate the added value of advanced practice nurses in France in the health system and particularly in oncology. It also adds value to clinical expertise nurse and register the profession in the research.
The hypothesis is that the quality and safety of care provided by a nurse practitioner are equivalent to those provided by a doctor at follow-up of patients with gastrointestinal cancer, treated with intravenous chemotherapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nurse practitioner consultation
standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer
Nurse practitioner consultation
Nurse practitioner consultation will be done standard chemotherapy for colorectal cancer
Standard consultation
standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer
Medical practitioner consultation
Medical practitioner consultation will be done standard chemotherapy for colorectal cancer.
Interventions
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standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer
Nurse practitioner consultation
Nurse practitioner consultation will be done standard chemotherapy for colorectal cancer
Medical practitioner consultation
Medical practitioner consultation will be done standard chemotherapy for colorectal cancer.
Eligibility Criteria
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Inclusion Criteria
* Treatment with intravenous chemotherapy or treatment with concomitant oral and intravenous chemotherapy.
* Patient beginning a cycle of chemotherapy he had already received chemotherapy sessions or not.
* Patient aged 18 or over.
* Patient with predictable life expectancy greater than 3 months.
* Patient speak and understand the French.
* Patient having read and understood the information letter and signed the consent form.
* For women of childbearing age: effective contraception 3 months before the start of treatment and negative blood pregnancy test
Exclusion Criteria
* Patient aged under 18.
* Prognosis committed within 3 months.
* Pregnant women or breastfeeding.
* Initial clinical assessment quoting fatigue to a higher grade 2 according to the WHO classification before the start of chemotherapy treatment.
* Against indication(s) for chemotherapy.
* Person deprived of liberty by an administrative or judicial decision or person under the protection of a conservator.
* History of disease or psychological or sensory abnormality that may prevent the patient to understand the requirements for participation in the protocol or preventing it from giving informed consent.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Pierre MICHEL, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Central Contacts
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Other Identifiers
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2015/211/HP
Identifier Type: -
Identifier Source: org_study_id
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