Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer — INCISIVE  

ColoRectal Cancer Clinical Trial

Official title: Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer, Requiring Intravenous Chemotherapy Versus a Medical Monitoring

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• ColoRectal Cancer
• Colorectal Neoplasms

• NCT number: NCT02956876
• Study type: Interventional
• Source: University Hospital, Rouen
• Contact: Hélène MAGNIER
• Email: helene.magnier@chu-rouen.fr
• Status: Recruiting
• Phase: Phase 3
• Start date: December 5, 2016
• Completion date: December 2020