Clinical trial NCT02956876: Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer
Official title: Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer, Requiring Intravenous Chemotherapy Versus a Medical Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: ColoRectal Cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 754
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France according to the latest report from the Institut national du Cancer (INCa). Second leading cause of cancer death in men, its management is a public health problem. According to projections by WHO, the prevalence of cancers expected to increase 50% by 2050 especially in digestive oncology. These projections can be concluded that the demand for care will continue to be growing.

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.


Eligibility criteria: Inclusion Criteria:

* Digestive diagnostic of colorectal cancer.
* 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 over 80.
* 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.

Primary outcomes:
measure: Number of side effects of chemotherapy for WHO grade greater than 2
timeFrame: Day 7
Secondary outcomes:
measure: Quality of life of patients by QLQC-30 questionnaire
timeFrame: Day 7
measure: Number of provisional chemotherapy orders
timeFrame: Day 7
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Pierre MICHEL, Pr
role: PRINCIPAL_INVESTIGATOR
References: