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Trial record 35 of 6801 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

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ClinicalTrials.gov Identifier: NCT02956876
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment Phase
ColoRectal Cancer Drug: standard chemotherapy for colorectal cancer Other: Nurse practitioner consultation Other: Medical practitioner consultation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 754 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer, Requiring Intravenous Chemotherapy Versus a Medical Monitoring
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nurse practitioner consultation
standard chemotherapy for colorectal cancer
Drug: standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer

Other: Nurse practitioner consultation
Nurse practitioner consultation will be done standard chemotherapy for colorectal cancer

Standard consultation
standard chemotherapy for colorectal cancer
Drug: standard chemotherapy for colorectal cancer
standard chemotherapy for colorectal cancer

Other: Medical practitioner consultation
Medical practitioner consultation will be done standard chemotherapy for colorectal cancer.




Primary Outcome Measures :
  1. Number of side effects of chemotherapy for WHO grade greater than 2 [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. Quality of life of patients by QLQC-30 questionnaire [ Time Frame: Day 7 ]
  2. Number of provisional chemotherapy orders [ Time Frame: Day 7 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956876


Contacts
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Contact: Hélène MAGNIER helene.magnier@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France
Principal Investigator: Pierre MICHEL, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Pierre MICHEL, Pr Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02956876     History of Changes
Other Study ID Numbers: 2015/211/HP
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Digestive System Neoplasms
Digestive System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases