Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer
INCISIVE
1 other identifier
interventional
207
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 colorectal-cancer
Started Dec 2016
Typical duration for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedStudy Start
First participant enrolled
December 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2022
CompletedFebruary 6, 2026
February 1, 2026
6 years
November 3, 2016
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of side effects of chemotherapy for WHO grade greater than 2
Day 7
Secondary Outcomes (2)
Quality of life of patients by QLQC-30 questionnaire
Day 7
Number of provisional chemotherapy orders
Day 7
Study Arms (2)
Nurse practitioner consultation
EXPERIMENTALstandard chemotherapy for colorectal cancer
Standard consultation
OTHERstandard chemotherapy for colorectal cancer
Interventions
standard chemotherapy for colorectal cancer
Nurse practitioner consultation will be done standard chemotherapy for colorectal cancer
Medical practitioner consultation will be done standard chemotherapy for colorectal cancer.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rouen University Hospital
Rouen, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre MICHEL, Pr
University Hospital, Rouen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2016
First Posted
November 7, 2016
Study Start
December 5, 2016
Primary Completion
November 19, 2022
Study Completion
November 19, 2022
Last Updated
February 6, 2026
Record last verified: 2026-02